Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia: Single-Blind Clinical Trial
Phase: NA
Conditions: Pneumonia Childhood, Rehabilitation, Recovery of Function
Sponsor: Hospital Infantil de Mexico Federico Gomez

Code HIM 2017-055 
 
 
 
Clinical Efficacy of Respiratory  
Pediatric Physiotherapy on a Child 
With  Hospital Treated Pneumonia: 
Single-Blind Clinical Trial 
 
 
 
 
 
Code HIM 2017-055 
Clinical Efficacy of Respiratory 
Pediatric Physiotherapy on a Child 
With Hospital Treated Pneumonia: 
Single-Blind Clinical Trial

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Code HIM 2017-055 
 
Index 
Code HIM 2017-055 .................................................................................................................................... 1 
SUMMARY ................................................................................................................................................... 4 
BACKGROUND ........................................................................................................................................... 5 
Pneumonia ................................................................................................................................................. 7 
 Anatomophysiological Characteristics of the child’s respiratory system .................................................. 8 
Treatment ................................................................................................................................................... 8 
Fundamentals of Respiratory Pediatric Physiotherapy applied as Adjuvant Treatment for Pneumonia ... 8 
PROBLEM STATEMENT ......................................................................................................................... 10 
JUSTIFICACION ........................................................................................................................................ 11 
OBJECTIVES ............................................................................................................................................. 11 
General objective ..................................................................................................................................... 11 
Specific objectives .................................................................................................................................... 11 
HYPOTHESIS ............................................................................................................................................ 11 
METHODOLOGY AND RESEARCH DESIGN ..................................................................................... 11 
Design ....................................................................................................................................................... 11 
Single-blind randomized clinical trial ....................................................................................................... 11 
Population ................................................................................................................................................ 11 
Sample size calculation ............................................................................................................................ 11 
Sampling method ..................................................................................................................................... 12 
Blinding ................................................................................................................................................. 12 
Selection Criteria ...................................................................................................................................... 12 
Inclusion criteria: .................................................................................................................................. 12 
Deferral criteria: ................................................................................................................................... 13 
Elimination criteria: .............................................................................................................................. 13 
Index 
Code HIM 2017-055 oo... cecccecsscseeseseeseseeseseescseeesenecsesecseseeseseeseseseeseeecseeeaeeessenecaeeeeseaeeseeeesesenseaeeeeaeeeeaeees 1 
SUMMARY uno. ccccceccscesesceseseeeseseesesessesessesescesesecsesecsesecacsecsesesseaeesesessesenecaeeessesecseeesaeseeseseeseseeseaeeseaeeesaeeeeaeees 4 
BACKGROUND 1.00... eceeeccecesesseseseeseseeceseseeseseesesesesesesesscseecsenecsesecsesecaesesseseeseseeseaeecaeeecaeeecaeeeseeeaeseeseateees 5 
PNEUMONIA 00... 
ee 
eee ceteeceseecnseeceseeceseeesssecesaeeesseecsseeceseecesaecesaecesaeecsseecsseccsseeceseecesaeeesaeeeaecesasecsaeeceseeosaees 7 
Anatomophysiological Characteristics of the child’s respiratory SYStOM.........ccccccccccccccesecceeeseeeeesteeeeeesees 8 
TIOQEMENE. 0... eececcccecneceenneeeceeneeeesenaeeecseaeecesnaeeesseaeeesenaeeceseaeecsesaeeceseaeeesenaeeceeeeecesenaeeeseeeeeesenaeeeesteeeeseaaes 8 
Fundamentals of Respiratory Pediatric Physiotherapy applied as Adjuvant Treatment for Pneumonia... 8 
PROBLEM STATEMENT 
000.0... eceeeeesssssseseseeseseseseeesesesesesesevacseaeseeecacscaeeesecscaeeeeesesscseaeeeesaeacaeeesesaeaeeees 10 
JUSTIFICACION. 
0... ceceescsssssseseseeeseecssseseeeeescsesesesevseaceeeesesscseeeseeaeacaeneseeacaeaeeeesseaeaeeeeesacaeeeeeeeraeaeeeeeees 11 
OBJECTIVES 20 
eee eescsesesseseseseeesesescseeeeecsesesesesesseseseuesesacscseeeeeeaeseeeesseseseeeesacseaeeeeeeesaeeceeeesesaeeeeeeeeesaes 11 
General Objective ........ 
cece ccccssssssceeccceeessseeeeccceesessseeeccecesesssseecececsesssseeescecseessaeeeseeeeeessaeeececeseetsseeeceeess 11 
SPECIFIC ODjfECTIVES 0... 
eee cceseccceessccceesseeeeseseeceeesseceeseeeeeeeseeeeeeseeeeeesseesesseecesesaeeessaeesesesaeseeeaseeeesesaeseneaaes 11 
HYPOTHESIS 000. ccecceeessseseseeeeseeseseseeceseseseseeeseacscaesesseacseaceeesacseaeueessaeseaceesecseaeeceeeesasacaeeeesecaeaeesesaeaeetes 11 
METHODOLOGY AND RESEARCH DESIGN 2... cceeeeseseeeeseseseneeeeeeseseneeeecseseneeeeesaeseneeeseraesenees 11 
DOSIN ooo. eeeeccccccccccececeeccececceccceecececeeeeeeeeesesesseeeeeeeeeeeesessssssssaasaaaaaaaaaaeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseseseseseseseseeeeeens 11 
Single-blind randomized clinical trial... ccccccccssseccessseecesssseceessseeecesseeeceesseecessseeseseseeseeeeeeeeseseeeeneaaes 11 
POPULATION 0... 
cece cccessecesescecsesseecesssseeesssseeeeseseeeseseecessseeeesesseeesesseesesesseeesesseeeeesusesesesueeesesueesesesaeeesenaeeees 11 
Sample Size CalCUlatiOn ........ eee ccescccssssccecssseeeceeseeceeesseeccssseeceesseeeessseeseseseeeeeesaeeeesseeseeeseeseeeeeeeeeeseeeeneaas 11 
SAMPLING Meth” 00.0... 
eee cccesscccsescccessseeeesseeccesseeeeessseeeeseseeeeeeeeseessseeseseseeeeeeseeeeseseeseeaseseesseeeeeseseeseneaaes 12 
BING... 
eee 
cc ccceesssscceccccesessceeecccesessscesccceesessseeeccceesesssaeeececeeessaeeeecceseessueeesecceeenssseeececeeensaseeeecens 12 
Selection Criteria... 
eee eccecsecseessceecsesscssecsecsecsscssesseceecesecsessesessesecasesesesscssssseeesaeesssessesesaeeseeeeeaes 12 
INCIUSION CLitePias oe eee eee ese cesceseeseeseeescesecseesesescesecssesecssccsecssesecesecsecsesesesasesscsesesesseseeseeseaesaeeseenaee 12 
Deferral Criteria: 0... eee cssceeeeesecsecesessecsssesccsesseesecssecsecssesscesecsesseceseeaesssssseaesaessesesseaesaeeeenaee 13 
Elimination Criteria: 
0. 
cece eceeeeceeceeceeessecesescesecsecseessecsecssescesecsesecesesaeessseseesesaesseeeeseaesaeeseeaee 13 
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Intervention group ................................................................................................................................... 14 
Intervention maneuvers ....................................................................................................................... 14 
Control group ........................................................................................................................................... 15 
Variables and measuring instruments ..................................................................................................... 15 
GENERAL DESCRIPTION OF THE STUDY ........................................................................................ 17 
Assessment prior to the procedure .......................................................................................................... 17 
Initiation and evaluation of the assigned maneuver ............................................................................... 17 
End of the study ....................................................................................................................................... 17 
DATA ANALYSIS PLAN ........................................................................................................................... 17 
LIMITATIONS OF THE STUDY .............................................................................................................. 17 
TIMELINE ................................................................................................................................................... 18 
ETHICAL CONSIDERATIONS ................................................................................................................ 18 
BIOSECURITY CONSIDERATIONS ...................................................................................................... 19 
PRODUCTS TO BE OBTAINED FROM THE STUDY ........................................................................ 19 
BIBLIOGRAPHIC REFERENCES .......................................................................................................... 19 
INTOFVENTION GOUD ......ccccccccccccceeeeene eee e tebe nett eee ennLLL EEE EEE ELLE EEE E EEE E ELLE EEE E EE ELLE EEEEE EEE CELA GEE E EE Ee ddA GEE E EEE E Eta Ea 14 
INteErVeENntiOn MANCUVETS......... 
cece eee ese cee cseeeseeceeeeseeeseeeseeceseceeeseeeseeesseecseesesaseessesecesesesseeaeeeeseeaengs 14 
CONELO] GOUP .....cccccccccccccesseceeenseeeeeeseeeeeesseeeeeeeeeeeesaeeeeeseeeeeesGeeeSEAGEEECELAEEESSEAGEEESEAGEEEEEAGGEEESAGEEEEeaGEEEESaEEEEEaa 15 
Variables and MeASUTING INSTFUIMENES ........cccccccccccccceseceeeessececesseeeseeeeeeseseeeceeseeeeseseeesesseesesesseeesseeeeeneaaes 15 
GENERAL DESCRIPTION OF THE STUDY uuu... cecceeeeeseseseneeeeseseseseeeseeseneeeeeeeeseseneeevesaeneneeesesaes 17 
Assessment prior to the ProCe Cure ........ccccccccccccccessececenseceeeenceeeseseeeeessseeeeseseeeessaeeeeeeseeeesesseeeeeseesenssseeeses 17 
Initiation and evaluation of the ASSIGNEA MANCUVEL ..........cccccccccesseccesesseseceseeesseseeeesesseeecessaeseseasesessesaeees 17 
End of the Study .0...... cece ccccccesssssceecccesessssceeccecesessseeeecccesesssseeececesesssceeeececsestsaeeeeeccsesesseeeececeeetsseeeeeseeenaas 17 
DATA ANALYSIS PLAN 0.0... cceeesesseseseseseseeesseseseseeeeeseseneseevacseseeeeaeacsceeneseescaeaeeeeesscaeaeeeeesaeaeaeeeeesacseeees 17 
LIMITATIONS OF THE STUDY 0.0... cceeeesseseeneeeeseseseseeeessseseneeeeescseaeeeeecasseaeeeeesscaeaeeeesacseaeeesesaeaeaees 17 
TIMELINE. 20... eeeeeesceeeeseeseseesesesscsesscseeseseasscessesesscsesacsesscsesaeseeacseeasaceassesessceessesesasetsaseeeacaeeeeaeeessenesaeees 18 
ETHICAL CONSIDERATIONS... ceeeceseseessseseseneeseseseseneseeeeseseneseecacseaeeeeacseseueeeeecseaeaeeeesseseneeeeesaeseeees 18 
BIOSECURITY CONSIDERATIONS... cecceceseseeseseseseeeeeseseseneseeseseseneseeeeseaeeceeeesscaeaeesesaeaeaeeeeesaeseaees 19 
PRODUCTS TO BE OBTAINED FROM THE STUDY ..0.0.. 
cc eeceseeeeeeseseseneeeeseseneneeeeeeseseneeesesseseaees 19 
BIBLIOGRAPHIC REFERENCES ...0...ccesssesssseseseseseeeeeseseseseeeeseseseneeeeesacseeeeesesaeaeaeeeeesaeseaeeesesaeaeetes 19 
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SUMMARY 
Pneumonia poses a public health problem in México, it is the main cause of mortality and 
hospital intervention in children younger than 5 years old according to the 2012 national survey 
of health and nutrition by ENSANUT. The WHO estimates an annual growth trend of 8 million 
new cases in Latin America, of which 9% require hospitalization. Hospital Treated Pneumonia 
lengthens a hospital stay by 5 days on average, which implies a sizable expense from the public 
health budget. 
The treatments recommended by guides and manuals in our country are based on the use of a 
series of antipyretics, analgesics and antibiotics, disregarding the problems caused by the 
detriment of the respiratory functions caused by pneumonia. 
 
PROBLEM STATEMENT, the accumulation of secretions in the bronchopulmonary air network 
promotes the detriment of respiratory functions generating hypoxia and causing a decrease in 
the cardiac output requiring the use of mechanical ventilation and hemodynamic support. It is 
intended to control the accumulation of secretions by means of Respiratory Pediatric 
Physiotherapy (RPP) and to evaluate its effectiveness counting on biological plausibility. 
 
The OBJECTIVE of this research protocol is to evaluate the effectiveness of RPP compared to 
postural drainage plus compression to the muscle belly of the upper limbs, as an adjuvant 
treatment for children with pneumonia. It is expected that the clinical severity decreases by 1.5 in 
the Wang score (a modification of the Silverman score), with a standard deviation of 2.6 points 
and a decrease of two days in the hospital stay with a α 0.05 in a one-tail test, a P of 80% and a 
95.5% confidence interval. 
 
METHODOLOGY, the protocol design corresponds to a single-blind trial. The population will 
consist of children aged from 0 to 8 years old diagnosed with pneumonia with a development 
time less than 7 days. The participants who comply with the selection criteria will be grouped in 
blocks of two using a randomization software (www.radomization.com). 
The sample calculation corresponds to 40 participants per group. The intervention group will be 
exposed to techniques such as prolonged slow expiration, controlled expiratory flow exercises, 
tracheal pumping and tracheal reflex. The control group will be subject to postural drainage plus 
compressions to the muscle belly of the upper limbs. Both groups will go through 10 sessions: 
One daily session from Monday to Friday with a duration of 10 to 15 minutes each. 
The Wang score (a modification of the Silverman score) will be used to measure the clinical 
severity and a pulse oximeter ChoiceMMed MD300C5 for SpO2 and heart rate readings, the 
medical records will be consulted during the hospital stay. 
 
DATA ANALYSIS PLAN, to prove whether there are or not statistical differences in and between 
both groups a Mann-Whitney U test will be used. The weightings from the Wang score (a 
modification of the Silverman score) will be considered before and immediately after the 
intervention maneuvers, and after 15, 30 and 120 minutes after said maneuvers have been 
performed. 
SUMMARY 
Pneumonia poses 
a public health problem 
in México, 
it 
is the main cause 
of mortality and 
hospital intervention in children younger than 5 years old according to the 2012 national survey 
of health and nutrition by ENSANUT. The WHO estimates an annual growth trend of 8 million 
new cases 
in Latin America, of which 9% require hospitalization. Hospital Treated Pneumonia 
lengthens a hospital stay by 5 days on average, which implies a sizable expense from the public 
health budget. 
The treatments recommended by guides and manuals in our country are based on the use of a 
series 
of antipyretics, analgesics and 
antibiotics, disregarding 
the problems caused 
by the 
detriment of the respiratory functions caused by pneumonia. 
PROBLEM STATEMENT, the accumulation of secretions in the bronchopulmonary air network 
promotes the detriment of respiratory functions generating hypoxia and causing a decrease in 
the cardiac output requiring the use of mechanical ventilation and hemodynamic support. 
It is 
intended 
to 
control 
the 
accumulation 
of 
secretions 
by 
means 
of 
Respiratory 
Pediatric 
Physiotherapy (RPP) and to evaluate its effectiveness counting on biological plausibility. 
The OBJECTIVE of this research protocol is to evaluate the effectiveness of RPP compared to 
postural drainage plus compression 
to the muscle belly of the upper limbs, 
as an adjuvant 
treatment for children with pneumonia. 
It is expected that the clinical severity decreases by 1.5 in 
the Wang score (a modification of the Silverman score), with a standard deviation of 2.6 points 
and a decrease of two days in the hospital stay with a a 0.05 in a one-tail test, a P of 80% anda 
95.5% confidence interval. 
METHODOLOGY, the protocol design corresponds to 
a single-blind trial. The population will 
consist of children aged from 0 to 8 years old diagnosed with pneumonia with a development 
time less than 7 days. The participants who comply with the selection criteria will be grouped 
in 
blocks of two using a randomization software (www.radomization.com). 
The sample calculation corresponds to 40 participants per group. The intervention group will be 
exposed to techniques such as prolonged slow expiration, controlled expiratory flow exercises, 
tracheal pumping and tracheal reflex. The control group will be subject to postural drainage plus 
compressions to the muscle belly of the upper limbs. Both groups will go through 10 sessions: 
One daily session from Monday to Friday with a duration of 10 to 15 minutes each. 
The Wang score (a modification of the Silverman score) will be used to measure the clinical 
severity and 
a pulse oximeter ChoiceMMed MD300C5 for SpOz and heart rate readings, the 
medical records will be consulted during the hospital stay. 
DATA ANALYSIS PLAN, to prove whether there are or not statistical differences in and between 
both groups a Mann-Whitney U 
test will be used. The weightings from the Wang score (a 
modification of the Silverman score) will be considered before and immediately after the 
intervention maneuvers, and after 15, 30 and 120 minutes after said maneuvers have been 
performed. 
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Code HIM 2017-055 
 
BACKGROUND 
The detriment of respiratory functions is one of the main sequels left by pneumonia, however, its 
treatment (curative, symptomatic or preventive) is not taken into consideration by the Mexican 
norm of “prevention and control of acute respiratory infections (ARI’s) during first care” NOM-
024-SSA2, nor by the 2011 guides for the treatment of nosocomial pneumonia updates from the 
department of infectiology at the Hospital Infantil de México Federico Gómez. In contrast, 
countries like Chile, *1,2 Belgium, *3 France,*3,4,5 Spain*4,6 and Switzerland*7 have turned to RPP 
during the three levels of public health care as an strategy to combat said detriment. 
 
In Chile, over a million physiotherapists are part of the national program “prevention and 
handling of acute respiratory infections in children”. *2 
 
In Switzerland, 4% of outpatients and 14.4% of hospitalized patients received said treatment 
during 2006. *7 
 
In Spain, during 2007, 7.3%of nursing babies treated in top class hospitals received RPP. *8 
 
There are reports of its use in countries such as Argentina, *9 Brazil, *10 Israel*11 and the   
          
United Kingdom. *12,13 
 
During 1998 to 2008, the mortality rate caused by ARIs decreased in Mexico by 46% and in 
Chile  by 70%. *14 There is probability of a co-relation between the inclusion of RPP in Chile’s 
health care system in 1990 and the countries’ significant decrease in the rate of mortality by 
ARIs. 
 
In our country the use of RPP is discrepant due to the use of techniques designed for adults 
(postural drainage, vibrations and percussions) applied on children, even though in 1994 the 
Fédération Française de Kinésithérapie Respiratoire recommended not using it for pediatrics, *16 
said techniques do not take into consideration the anatomophysiological or mechanical 
characteristics of newborns, nursing babies and children, which jeopardizes the health of the 
patient. *17 
 
The collected published works about the clinical efficiency of RPP are not unanimous in their 
conclusions. 
The strongest evidence of RPP on children with pneumonia comes from a systematic Cochrane 
review (SCR), *18 which takes into consideration 3 randomized controlled trials (RCT) *19,20,21 with 
a total of 255 participants (Table 1). The authors consider that the diversity in age range, 
intervention maneuvers, execution time and methodological inefficiency in the selected articles 
makes it impossible to reach a conclusion about their efficiency. 
 
RPP prevents, enables and rehabilitates the pulmonary functions from physiological or structural 
alterations in the respiratory system. In a child, the main alterations are those caused by the 
accumulation of secretions (pneumonia, atelectasis, chronic obstructive lung disease, restrictive 
lung disease, collapsed lung, progressive proteolytic destruction of the bronchial wall structure, 
lung hyperinflation and lung abscess, just to name a few). Its objective is to control the 
accumulation of secretions considering the dynamics of fluids and the anatomophysiological 
characteristics of the normal development of the child, which are described in the paragraphs 
Fundamentals of Respiratory Pediatric Physiotherapy Applied as Adjuvant Treatment for 
Pneumonia and Intervention Maneuvers. 
BACKGROUND 
The detriment of respiratory functions is one of the main sequels left by pneumonia, however, its 
treatment (curative, symptomatic or preventive) 
is not taken into consideration by the Mexican 
norm of “prevention and control of acute respiratory infections (ARI’s) during first care” NOM- 
024-SSA2, nor by the 2011 guides for the treatment of nosocomial pneumonia updates from the 
department 
of infectiology 
at the 
Hospital 
Infantil 
de México Federico Gdmez. 
In 
contrast, 
countries like Chile, '? Belgium, * France, **° Spain® and Switzerland’ have turned to RPP 
during the three levels of public health care as an strategy to combat said detriment. 
In Chile, over a million physiotherapists are part of the national program “prevention and 
handling of acute respiratory infections in children”. ? 
In Switzerland, 4% of outpatients and 14.4% of hospitalized patients received said treatment 
during 2006.” 
In Spain, during 2007, 7.3%of nursing babies treated in top class hospitals received RPP. ® 
There are reports of its use in countries such as Argentina, ° Brazil, “'° Israel’ and the 
United Kingdom. “'*:'% 
During 1998 to 2008, the mortality rate caused by ARIs decreased in Mexico by 46% and in 
Chile 
by 70%.“ There is probability of a co-relation between the inclusion of RPP in Chile’s 
health care system in 1990 and the countries’ significant decrease in the rate of mortality by 
ARIs. 
In our country the use of RPP 
is discrepant due to the use of techniques designed for adults 
(postural drainage, vibrations and percussions) applied on children, even though 
in 1994 the 
Fédération Francaise de Kinésithérapie Respiratoire recommended not using it for pediatrics, *'® 
said 
techniques 
do 
not 
take 
into 
consideration 
the 
anatomophysiological 
or 
mechanical 
characteristics of newborns, nursing babies and children, which jeopardizes the health of the 
patient.” 
The collected published works about the clinical efficiency of RPP are not unanimous in their 
conclusions. 
The strongest evidence of RPP on children with pneumonia comes from a systematic Cochrane 
review (SCR), *'® which takes into consideration 3 randomized controlled trials (RCT) “'??°?' with 
a total 
of 255 participants (Table 
1). The authors consider that the diversity 
in age range, 
intervention maneuvers, execution time and methodological inefficiency in the selected articles 
makes it impossible to reach a conclusion about their efficiency. 
RPP prevents, enables and rehabilitates the pulmonary functions from physiological or structural 
alterations 
in the respiratory system. 
In a child, the main alterations are those caused by the 
accumulation of secretions (pneumonia, atelectasis, chronic obstructive lung disease, restrictive 
lung disease, collapsed lung, progressive proteolytic destruction of the bronchial wall structure, 
lung 
hyperinflation and 
lung abscess, just 
to name 
a few). 
Its objective 
is 
to control 
the 
accumulation 
of secretions considering the dynamics 
of fluids and the anatomophysiological 
characteristics of the normal development of the child, which are described 
in the paragraphs 
Fundamentals 
of Respiratory 
Pediatric Physiotherapy Applied 
as Adjuvant 
Treatment 
for 
Pneumonia and Intervention Maneuvers. 
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Table 1. Characteristics of the RCTs considered by the SCR*18 
 
Author Comparison 
n 
Results 
Weaknesses 
Lukrafka 
JL, et al. *19 
 
 
 
 
 
Paludo C, 
et al. *20 
Intervention: TV, CC, PEEP, ELTGOL and        72 
H C .              
Control: PD. 
Time: 3 times a day. 
Intervention: CC, TV, PD, CP, HC and 
98 
Aspiration of secretions (if needed). 
Control: Standardized medical treatment. 
No differences during 
the HS (6 vs 8, p=0.11). 
                                         
No statistical significance   
in clinical resolution (4 vs 4, 
p=0.84) or in the HS (6 vs 6, 
p=0.76). 
CT and MT were used. 
Blinding not reported. 
Morphological stratification error.  
Chronometric stratification error. 
Stratification error due to 
comorbidity. 
 
CT were used.                                      
Blinding not reported. 
Clinical stratification error. 
Chronometric stratification error.                         
Stratification error due to                        
comorbidity. 
 
Zhao SK, Intervention: CPAP (instrumental technique). 94 
No statistical 
Intervention maneuver is 
et al. *21 
Control: Standardized medical treatment. 
Time: During hospital stay. 
significance 
in 
clinical 
resolution. At 12 hours 
from intervention 94.1 ± 
0.9. 
instrumental. 
Stratification error by status. 
 Morphological stratification error. 
 Blinding method not 
described. 
 
 
TV= thoracicHSibrations, CC= chest compressions, PEEP= positive end-expiratory pressure, CP= chest percussion, CPAP= continuous positive airway pressure, PD= postural drainage       
CT= conventional techniques, MT= modern techniques and HC= huff coughing. 
  
Table 1. Characteristics of the RCTs considered by the SCR'"® 
Author 
Comparison 
n 
Lukrafka _—— [ntervention: TV, CC, PEEP, ELTGOL and 
72 
JL, etal. 
UC. 
Control: PD. 
Time: 3 times a day. 
Paludo C, 
Intervention: CC, TV, PD, CP, HC and 
98 
etal.*20 
Aspiration of secretions (if needed). 
Control: Standardized medical treatment. 
Zhao SK, 
Intervention: CPAP (instrumental technique). 
94 
etal.’21 | Control: Standardized medical treatment. 
Time: During hospital stay. 
Results 
No differences during 
the HS (6 vs8, p=0.11). 
No statistical significance 
in clinical resolution (4 vs 4, 
p=0.84) or in the HS (6 vs 6, 
p=0.76). 
No statistical 
significance 
in __ 
clinical 
resolution. 
At 
12 
hours 
from 
intervention 
94.1 
+ 
0.9. 
Weaknesses 
CT and MT were used. 
Blinding not reported. 
Morphological stratification error. 
Chronometric stratification error. 
Stratification error due to 
comorbidity. 
CT were used. 
Blinding not reported. 
Clinical stratification error. 
Chronometric stratification error. 
Stratification error due to 
comorbidity. 
Intervention maneuver is 
instrumental. 
Stratification error by status. 
Morphological stratification error. 
Blinding method not 
described. 
TV= thoracicHSibrations, CC= chest compressions, PEEP= positive end-expiratory pressure, CP= chest percussion, CPAP= continuous positive airway pressure, PD= postural drainage 
CT= conventional techniques, MT= modern techniques and HC= huff coughing. 
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Pneumonia 
151 million new cases of pneumonia in children younger than 5 years old are reported 
worldwide, being the cause of 19% of deaths inside that age range, according to the WHO’s 
newsletter from May 2008. 
 
In Latin America 8 million new cases are registered each year, from which 9% require 
hospitalization. *22 
 
In 2008 in Mexico, 15,096 cases were registered and during 2009 a death rate of 19.6 out of 
every one hundred thousand was reported in children younger than five years old. 
 
In Mexico, pneumonia is a public health problem, since it is the first cause of death and hospital 
admission in children younger than 5 years old, according to the National Health and Nutrition 
Survey from 2012. 
 
Nosocomial infections represent a worldwide health problem. A survey made to 21 hospitals in 
Mexico showed that nosocomial infections represent 25% of infections in our country, and their 
morbidity and mortality rate shows a discrepancy from 1 to 36 cases for every 100 hospital 
discharges depending on the geography and level of care. *23 
 
Pneumonia is the acute multifactorial infection (caused by virus, bacteria or fungus) *24,25 of the 
lung parenchyma, characterized by the presence of cellular exudation, inflammation and 
infiltration in bronchiole, alveolus and occasionally bronchus. *26,27 
It can affect 1.a lobe 2.lobe segments 3.alveoli, or the 4.interstitial spaces. *28 
 
In-hospital pneumonia (IP) may be classified as early, when it develops between the second and 
seventh day of the hospital stay (HS). Late, when it presents itself at the eighth day of HS. And 
ventilator associated, when it emerges after 48 hours of exposure to the ventilator. *26 
 
IP prognosis has a 20% chance mortality rate while ventilator associated pneumonia has a 29%. 
*29 
 
IP extends HS by 5 days on average, *14 a condition that compromises the wellbeing of minors 
and increases the cost of its treatment, which in the public health system is covered by the 
Public Health Fund. 
 
The diagnosis in children younger than 5 years old presents a certain level of complexity, that is 
why the WHO’s guidelines from 2016 recommend the following diagnostic criteria: 
1. Symptoms: Coughing, respiratory difficulties, oral rejection, abdominal pain. 
2. Signs: Feber, tachypnea, intercostal retractions, nasal flaring, grunting, decrease in 
vesicular murmur, dullness to percussion, rales, wheezing. 
 
The complementary studies from offices and laboratories for diagnosis include X-rays of the 
thorax, biopsy, cytology of the bronchial lavage and Gram Stain. * 30,31,32 
Pneumonia 
151 
million 
new cases 
of pneumonia 
in 
children younger than 
5 
years 
old 
are 
reported 
worldwide, being the cause of 19% of deaths inside that age range, according to the WHO’s 
newsletter from May 2008. 
In 
Latin America 
8 
million 
new cases 
are 
registered 
each 
year, 
from 
which 
9% 
require 
hospitalization. 72 
In 2008 in Mexico, 15,096 cases were registered and during 2009 a death rate of 19.6 out of 
every one hundred thousand was reported in children younger than five years old. 
In Mexico, pneumonia is a public health problem, since 
it is the first cause of death and hospital 
admission in children younger than 5 years old, according to the National Health and Nutrition 
Survey from 2012. 
Nosocomial infections represent a worldwide health problem. A survey made to 21 hospitals in 
Mexico showed that nosocomial infections represent 25% of infections in our country, and their 
morbidity and mortality rate shows a discrepancy from 
1 
to 36 cases for every 100 hospital 
discharges depending on the geography and level of care. 7° 
Pneumonia is the acute multifactorial infection (caused by virus, bacteria or fungus) **° of the 
lung 
parenchyma, 
characterized 
by 
the 
presence 
of 
cellular 
exudation, 
inflammation 
and 
infiltration in bronchiole, alveolus and occasionally bronchus. 7°77 
It can affect 1.a lobe 2.lobe segments 3.alveoli, or the 4.interstitial spaces. 7° 
In-hospital pneumonia (IP) may be classified as early, when it develops between the second and 
seventh day of the hospital stay (HS). Late, when 
it presents itself at the eighth day of HS. And 
ventilator associated, when it emerges after 48 hours of exposure to the ventilator. ‘7° 
IP prognosis has a 20% chance mortality rate while ventilator associated pneumonia has a 29%. 
*29 
IP extends HS by 5 days on average, '"* a condition that compromises the wellbeing of minors 
and increases the cost of its treatment, which 
in the public health system 
is covered by the 
Public Health Fund. 
The diagnosis in children younger than 5 years old presents a certain level of complexity, that is 
why the WHO's guidelines from 2016 recommend the following diagnostic criteria: 
1. Symptoms: Coughing, respiratory difficulties, oral rejection, abdominal pain. 
2. 
Signs: Feber, tachypnea, intercostal retractions, nasal flaring, grunting, decrease in 
vesicular murmur, dullness to percussion, rales, wheezing. 
The complementary studies from offices and laboratories for diagnosis include X-rays of the 
thorax, biopsy, cytology of the bronchial lavage and Gram Stain. °°31.32 
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Infection starts when germs enter the lower respiratory tract, either by aspiration or extension of 
an adjacent space. *32 This produces a release of mediators of inflammation, alongside a 
dilatation of the blood vessels and a capillary leak that infiltrates the submucosa of the plasmic 
fluid and proteins, thus creating the obstruction mechanism. The edema inflames the mucosa 
and the plasmic exudate increases the volume of secretions, which become hyperviscous, 
increasing the difficulty of their expulsion. *26,27 
 
The accumulation of secretions in the bronchopulmonary network reduces physiological dead 
space, gas exchange, inspiration time and pulmonary compliance, generating an increase in air 
resistance and respiratory frequency. Said pulmonary restrictions often conclude in bronchial 
hyperreactivity. The accumulation of secretions can also cause atelectasis or pneumonic 
restrictions.  
 
Anatomophysiological characteristics of the child’s respiratory system 
The child’s respiratory system has a high potential for cellular renewal, cicatrization and repair. 
Its position, dimensions and relations morph with age. The alterations suffered during its 
development can affect the morphology and functionality of the ribcage, airways, pulmonary 
parenchyma and vascular bed. 
In a child, the ribcage is less efficient compared to an adult’s due to its more horizontal 
positioning and flexibility of the sternum and ribs. 
The larynx is situated higher, the epiglottis is of a smaller diameter and verticalized, the laxity of 
the cartilages promotes its own collapse during inspiration, and pulmonary compliance makes 
them prone to the collapse of peripheral airways. 
 
Intercostal, supra sternal, subcostal retractions and xiphoid retraction are present when 
pulmonary restrictions occur, increasing the action of the respiratory muscles and calorie output 
*33,34 This situation worsens with the hypoventilation that follows thoracic pains or pleural effusion 
due to compression of the pulmonary parenchyma, resulting in arterial hypoxia and an increase 
in the alveolar-arterial oxygen gradient. 
 
Hyperventilation is a response to the inflammation of the parenchyma or the chemoreceptors 
due to arterial hypoxemia, increasing PaO2 and decreasing PaCO2. Arterial hypoxemia caused 
by alterations of ventilation and perfusion is proportional to the extension of the pneumonia, 
normocapnia and hypocapnia are dependent to the raise of the alveolar-arterial oxygen gradient. 
 
Treatment 
Health organizations in Mexico base their conventional intervention on a diversity of antibiotics, 
analgesics and antipyretics recommended by the official norm 024-SSA2-11994. 
Conventional handling can not estimate the possible benefits that the treatment of the 
deterioration of respiratory functions has on the public health system and the public funds. RPP 
as adjuvant treatment has biologic plausibility. 
 
Fundamentals of Respiratory Pediatric Physiotherapy applied as Adjuvant Treatment for 
Pneumonia  
Its intervention seeks to achieve respiratory prosperity, and not the treatment of the infection, 
that is why its intervention is an adjuvant treatment. 
 
If the deterioration of pulmonary functions due to accumulation of secretions is not controlled, 
ends in the need of mechanical ventilation and hemodynamic support. *35 
Infection starts when germs enter the lower respiratory tract, either by aspiration or extension of 
an adjacent space. 
*? This produces 
a release 
of mediators 
of inflammation, alongside 
a 
dilatation of the blood vessels and a capillary leak that infiltrates the submucosa of the plasmic 
fluid and proteins, thus creating the obstruction mechanism. The edema inflames the mucosa 
and 
the plasmic exudate increases the volume 
of secretions, which become hyperviscous, 
increasing the difficulty of their expulsion. “°°?” 
The accumulation of secretions 
in the bronchopulmonary network reduces physiological dead 
space, gas exchange, inspiration time and pulmonary compliance, generating an increase in air 
resistance and respiratory frequency. Said pulmonary restrictions often conclude 
in bronchial 
hyperreactivity. 
The accumulation 
of secretions 
can 
also cause 
atelectasis 
or pneumonic 
restrictions. 
Anatomophysiological characteristics of the child’s respiratory system 
The child’s respiratory system has a high potential for cellular renewal, cicatrization and repair. 
Its 
position, dimensions and 
relations morph 
with 
age. 
The 
alterations 
suffered 
during 
its 
development can affect the morphology and functionality of the ribcage, airways, pulmonary 
parenchyma and vascular bed. 
In 
a 
child, 
the ribcage 
is 
less 
efficient compared 
to 
an 
adult’s due 
to 
its more 
horizontal 
positioning and flexibility of the sternum and ribs. 
The larynx is situated higher, the epiglottis is of a smaller diameter and verticalized, the laxity of 
the cartilages promotes its own collapse during inspiration, and pulmonary compliance makes 
them prone to the collapse of peripheral airways. 
Intercostal, 
supra 
sternal, 
subcostal 
retractions 
and 
xiphoid 
retraction 
are 
present 
when 
pulmonary restrictions occur, increasing the action of the respiratory muscles and calorie output 
"33:34 This situation worsens with the hypoventilation that follows thoracic pains or pleural effusion 
due to compression of the pulmonary parenchyma, resulting in arterial hypoxia and an increase 
in the alveolar-arterial oxygen gradient. 
Hyperventilation 
is a response to the inflammation of the parenchyma or the chemoreceptors 
due to arterial hypoxemia, increasing PaOz and decreasing PaCOz. Arterial hypoxemia caused 
by alterations of ventilation and perfusion 
is proportional to the extension of the pneumonia, 
normocapnia and hypocapnia are dependent to the raise of the alveolar-arterial oxygen gradient. 
Treatment 
Health organizations in Mexico base their conventional intervention on a diversity of antibiotics, 
analgesics and antipyretics recommended by the official norm 024-SSA2-11994. 
Conventional 
handling 
can 
not 
estimate 
the 
possible 
benefits 
that 
the 
treatment 
of the 
deterioration of respiratory functions has on the public health system and the public funds. RPP 
as adjuvant treatment has biologic plausibility. 
Fundamentals of Respiratory Pediatric Physiotherapy applied as Adjuvant Treatment for 
Pneumonia 
Its intervention seeks to achieve respiratory prosperity, and not the treatment of the infection, 
that is why its intervention is an adjuvant treatment. 
If the deterioration of pulmonary functions due to accumulation of secretions is not controlled, 
ends in the need of mechanical ventilation and hemodynamic support. °° 
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The deterioration of respiratory functions can be prevented or controlled by controlling the 
accumulation of secretions. 
 
Physiotherapy application methodology is dependent on the evaluation of clinical manifestations. 
*36 The choosing of the intervention maneuver must consider the following variables: age, stage 
of the natural history of the disease, physical exploration, its classification of chronic obstructive 
pulmonary disease, changes in pressure and the dynamics of fluids. 
 
RPP maneuvers are based on manual techniques (on patients without awareness of movement) 
or on assisted active contractions of the inspiration and respiration muscles (on patients with 
awareness of movement) to modify pleural pressure, pulmonary volume and the pressure inside 
alveoli.  The variations in pleural and transpulmonary pressure, and pleural pressure gradient 
must be greater than the resistance of the airways, elastic pressure an inertia.
The deterioration 
of respiratory functions can 
be prevented 
or controlled 
by controlling the 
accumulation of secretions. 
Physiotherapy application methodology is dependent on the evaluation of clinical manifestations. 
8 The choosing of the intervention maneuver must consider the following variables: age, stage 
of the natural history of the disease, physical exploration, its classification of chronic obstructive 
pulmonary disease, changes in pressure and the dynamics of fluids. 
RPP maneuvers are based on manual techniques (on patients without awareness of movement) 
or on assisted active contractions of the inspiration and respiration muscles (on patients with 
awareness of movement) to modify pleural pressure, pulmonary volume and the pressure inside 
alveoli. 
The variations in pleural and transpulmonary pressure, and pleural pressure gradient 
must 
be 
greater 
than 
the 
resistance 
of 
the 
airways, 
elastic 
pressure 
an_ 
inertia. 
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PROBLEM STATEMENT 
The accumulation of secretions within the broncho-pulmonary airway network causes the 
deterioration of respiratory functions (atelectasis, pulmonary hyperinflation, restrictive lung 
disease, collapsed lung, progressive proteolytic destruction of the bronchial wall structure, lung 
abscess, recurrent bronchial obstruction and respiratory distress syndrome) worsened to 
hypoxia and causing a decrease in cardiac output, which may need the use of mechanical 
ventilation and hemodynamic support. *35 
 
RPP stimulates the control of secretion accumulation modifying pleural and intraalveolar 
pressure and pulmonary volumes through passive, active-assisted or active contractions of the 
inspiratory and expiratory muscles, altering the line of air flow at will. RPP consists of two 
stages: 
 
1. Secretion sweeping: Secretions generate resistance to the line of air flow, turning 
laminar flow into turbulent flow. The handling at will of inspiration and expiration time 
increases the intensity of the turbulence and cilia movement, causing the secretions to 
detach due to the transmission of energy described by Newton’s third law in the zones 
where secretions and line of air flow make contact. 
prolonged slow expiration, FET and controlled expiratory flow exercises will be used. 
 
2. Secretion expulsion: The expelling of secretions through the airways is wanted by 
stimulating deglutition and active or assisted coughing. Tracheal pumping will be used. 
 
The control of secretion accumulation in the broncho-pulmonary airway network tends to 
decrease air flow resistance and respiratory frequency (RF), and to regain alveolar space, 
normalizing inspiration time, bronchial permeability and pulmonary mechanics. 
 
The effectiveness of said techniques has not been proved, since present evidence combines 
them with techniques designed for adult patients. 
 
Research questions: 
 
 
1. What is the effectiveness of RPP in comparison to postural drainage (PD) plus 
muscle belly compressions to the upper limbs for the reduction of clinical severity 
(in Wang score (a modification of the Silverman score)) for a child with 
pneumonia, 15, 30 and 150 minutes after it is performed? 
 
2. What is the effectiveness of RPP compared to PD plus muscle belly 
compressions to the upper limbs for the decrease in days of hospital stay for 
children with pneumonia? 
PROBLEM STATEMENT 
The accumulation 
of secretions 
within 
the broncho-pulmonary airway network causes 
the 
deterioration 
of 
respiratory functions 
(atelectasis, 
pulmonary 
hyperinflation, 
restrictive 
lung 
disease, collapsed lung, progressive proteolytic destruction of the bronchial wall structure, lung 
abscess, 
recurrent 
bronchial 
obstruction 
and 
respiratory distress syndrome) worsened 
to 
hypoxia and causing 
a decrease 
in cardiac output, which may need the use of mechanical 
ventilation and hemodynamic support. °° 
RPP 
stimulates 
the 
control 
of secretion 
accumulation 
modifying 
pleural 
and _ intraalveolar 
pressure and pulmonary volumes through passive, active-assisted or active contractions of the 
inspiratory and expiratory muscles, altering the 
line 
of air flow 
at will. RPP consists 
of two 
stages: 
1. Secretion sweeping: Secretions generate resistance 
to the 
line 
of air flow, turning 
laminar flow into turbulent flow. The handling at will of inspiration and expiration time 
increases the intensity of the turbulence and cilia movement, causing the secretions to 
detach due to the transmission of energy described by Newton’s third law in the zones 
where secretions and line of air flow make contact. 
prolonged slow expiration, FET and controlled expiratory flow exercises will be used. 
2. Secretion expulsion: The expelling 
of secretions through the airways 
is wanted 
by 
stimulating deglutition and active or assisted coughing. Tracheal pumping will be used. 
The 
control 
of secretion 
accumulation 
in 
the broncho-pulmonary airway network tends 
to 
decrease 
air flow resistance and respiratory frequency (RF), 
and 
to regain alveolar space, 
normalizing inspiration time, bronchial permeability and pulmonary mechanics. 
The effectiveness of said techniques has not been proved, since present evidence combines 
them with techniques designed for adult patients. 
Research questions: 
1. What is the effectiveness of RPP in comparison to postural drainage (PD) plus 
muscle belly compressions to the upper limbs for the reduction of clinical severity 
(in 
Wang 
score 
(a 
modification 
of 
the 
Silverman 
score)) 
for 
a 
child 
with 
pneumonia, 15, 30 and 150 minutes after it is performed? 
2. What 
is 
the 
effectiveness 
of 
RPP 
compared 
to 
PD 
plus 
muscle 
belly 
compressions to the upper limbs for the decrease 
in days of hospital stay for 
children with pneumonia? 
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JUSTIFICATION 
25% of nosocomial infections in our country are in-hospital pneumonia. 
In-hospital pneumonia increases hospital stay by 5 days on average and increases 
hospitalization costs. 
If respiratory pediatric physiotherapy is proven to be useful, days in hospital stay and 
hospitalization costs may decrease. 
 
Not performing this research protocol will promote the empirical prescription of said techniques 
by the public health system. 
 
OBJECTIVES 
General objective 
To evaluate the effectiveness of RPP compared to PD plus muscle belly compressions to the 
upper limbs for the treatment of a child with pneumonia. 
 
Specific objectives 
To evaluate the prolonged effects (15, 30 and 150 minutes after intervention) of RPP on clinical 
severity (Wang score (a modification of the Silverman score)) in comparison to PD plus muscle 
belly compressions to the upper limbs for the treatment of a child with in-hospital pneumonia. 
 
To evaluate the effect of RPP compared to PD plus muscle belly compressions to the upper 
limbs on the number of days of HS of children with pneumonia. 
 
HYPOTHESIS 
1. Children with pneumonia who receive RPP Will have a decrease of 1.5 points, with a 
standard deviation of 2.6 In the Wang score (a modification of the Silverman score), 30 minutes 
after it being performed. 
2. Children with pneumonia will have a decrease in HS of two days, compared to those treated 
with PD plus muscle belly compressions to the upper limbs. 
 
 
METHODOLOGY AND RESEARCH DESIGN 
DESIGN 
Single-blind randomized clinical trial 
 
Population 
1. Study universe: Hospitalized children with pneumonia at the infectiology service. 
2. Study population: Children from 0 to 8 years old with a diagnostic of pneumonia (under 
WHO’s criteria) with a development time less than 7 days. 
3. Sample: With the support of the epidemiology department, a daily list of all new cases of 
pneumonia will be provided. Patients then will be included once the diagnostic established by 
the pneumonia infectiology service is obtained.  
Sample size calculation 
The calculation for a sample size for an error of α 0.05 in a one-tail test and a power of 80% is 
based on the values described by Postiaux*37 in the difference between the groups 30 minutes 
after the intervention, during 10 sessions. The difference in the Wang score (a modification of 
the Silverman score) measurements between the two groups was of 1.5 points with a standard 
deviation of 2.6 points. 
JUSTIFICATION 
25% of nosocomial infections in our country are in-hospital pneumonia. 
In-hospital pneumonia increases hospital stay by 5 days on average and increases 
hospitalization costs. 
If respiratory pediatric physiotherapy is proven to be useful, days in hospital stay and 
hospitalization costs may decrease. 
Not performing this research protocol will promote the empirical prescription of said techniques 
by the public health system. 
OBJECTIVES 
General objective 
To evaluate the effectiveness of RPP compared to PD plus muscle belly compressions to the 
upper limbs for the treatment of a child with pneumonia. 
Specific objectives 
To evaluate the prolonged effects (15, 30 and 150 minutes after intervention) of RPP on clinical 
severity (Wang score (a modification of the Silverman score)) in comparison to PD plus muscle 
belly compressions to the upper limbs for the treatment of a child with in-hospital pneumonia. 
To evaluate the effect of RPP compared to PD plus muscle belly compressions to the upper 
limbs on the number of days of HS of children with pneumonia. 
HYPOTHESIS 
1. Children with pneumonia who receive RPP Will have a decrease of 1.5 points, with a 
standard deviation of 2.6 In the Wang score (a modification of the Silverman score), 30 minutes 
after it being performed. 
2. Children with pneumonia will have a decrease in HS of two days, compared to those treated 
with PD plus muscle belly compressions to the upper limbs. 
METHODOLOGY AND RESEARCH DESIGN 
DESIGN 
Single-blind randomized clinical trial 
Population 
1. Study universe: Hospitalized children with pneumonia at the infectiology service. 
2. Study population: Children from 0 to 8 years old with a diagnostic of pneumonia (under 
WHO's criteria) with a development time less than 7 days. 
3. Sample: With the support of the epidemiology department, a daily list of all new cases of 
pneumonia will be provided. Patients then will be included once the diagnostic established by 
the pneumonia infectiology service is obtained. 
Sample size calculation 
The calculation for a sample size for an error of a 0.05 in a one-tail test and a power of 80% is 
based on the values described by Postiaux’’ in the difference between the groups 30 minutes 
after the intervention, during 10 sessions. The difference in the Wang score (a modification of 
the Silverman score) measurements between the two groups was of 1.5 points with a standard 
deviation of 2.6 points. 
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Sampling method 
 
∆= 1.5 
S= 2.6 
n = 2S2(Zα/2 + Zβ)/∆2 
 
n=2(2.6)2(1.64+0.84)/(1.5)2=37 
 
The participants’ sample size will be of 40 per group, to obtain statistical differences in the 
decrease of the Wang score (a modification of the Silverman score) entre between both groups 
with a α 0.05 in a one-tail test and a power of 80%, considering a decrease of 36% and a 
standard deviation of 13%. 
 
Randomization 
 
1. A sequence of aleatory numbers in blocks of 2 will be generated in each of the study groups 
using the software randomization.com, done by a person foreign to the research. 
2. Using the randomized numbers generated by the software, it will be decided what group each 
participant belongs to (control or intervention) and what maneuver will be assigned to them. 
3. These numbers and their maneuvers will be placed inside dark envelopes. 
4. The whole randomization and assignment sequence will be performed by a person foreign to 
the research and without the knowledge of the researchers. Support will be provided from the 
coordination for nursing research, who will select the personnel for the process. 
 
Blinding 
After the assignment of the procedure, it will be blinded for the collaborator capacitated to 
measure the Wang score (a modification of the Silverman score), heart rate, SaO2 and 
registering the days of hospital stay posterior to the pneumonia diagnosis. Data capture will be 
performed by the personnel previously selected by the coordination for nursing research, without 
the knowledge of the researchers. 
 
Selection criteria 
 
Inclusion criteria: 
1. Patients from the HIMFG with diagnosis of pneumonia (considering the diagnostic criteria of 
the WHO and the Guidelines for Nosocomial Pneumonia from the infectiology department at 
the HIMFG) registered by the department of in-hospital epidemiology: 
1.1. Diagnostic criteria: 
a. Radiological, clinical and from laboratory: 
1. Radiology: Counting with at least one of the following findings: 
2. New, progressive or persistent infiltrate. 
3. Consolidation. 
4. Cavitating. 
5. Pneumatocele in children younger than 1 year old. 
 
b. Signs, symptoms and laboratory data: 
At least one of the following findings. 
1. Core temperature > 38.5°C o < 36°C (or rectal temperature >38 C° for at least 30 
minutes after discarding the cause of external overheating, for example: overclothing) 
Sampling method 
A= 1.5 
S= 2.6 
n = 2S?(Zui2 + Zp)/A? 
n=2(2.6)*(1.64+0.84)/(1.5)°=37 
The participants’ sample size will be 
of 40 per group, 
to obtain statistical differences 
in the 
decrease of the Wang score (a modification of the Silverman score) entre between both groups 
with 
a a 0.05 
in 
a one-tail test and 
a power of 80%, considering 
a decrease of 36% and 
a 
standard deviation of 13%. 
Randomization 
1. A sequence of aleatory numbers in blocks of 2 will be generated in each of the study groups 
using the software randomization.com, done by a person foreign to the research. 
2. Using the randomized numbers generated by the software, it will be decided what group each 
participant belongs to (control or intervention) and what maneuver will be assigned to them. 
3. These numbers and their maneuvers will be placed inside dark envelopes. 
4. The whole randomization and assignment sequence will be performed by a person foreign to 
the research and without the knowledge of the researchers. Support will be provided from the 
coordination for nursing research, who will select the personnel for the process. 
Blinding 
After the assignment of the procedure, 
it will 
be blinded 
for the collaborator capacitated 
to 
measure 
the Wang 
score 
(a 
modification 
of the Silverman 
score), 
heart 
rate, 
SaOz and 
registering the days of hospital stay posterior to the pneumonia diagnosis. Data capture will be 
performed by the personnel previously selected by the coordination for nursing research, without 
the knowledge of the researchers. 
Selection criteria 
Inclusion criteria: 
1. Patients from the HIMFG with diagnosis of pneumonia (considering the diagnostic criteria of 
the WHO and the Guidelines for Nosocomial Pneumonia from the infectiology department at 
the HIMFG) registered by the department of in-hospital epidemiology: 
1.1. Diagnostic criteria: 
a. Radiological, clinical and from laboratory: 
1. Radiology: Counting with at least one of the following findings: 
2. New, progressive or persistent infiltrate. 
3. Consolidation. 
4. Cavitating. 
5. Pneumatocele in children younger than 
1 year old. 
b. Signs, symptoms and laboratory data: 
At least one of the following findings. 
1. Core temperature 
> 38.5°C 
o 
< 36°C (or rectal temperature >38 C° for at least 30 
minutes after discarding the cause of external overheating, for example: overclothing) 
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2. Tachycardia (with no evident clinical cause) >2 standard deviation for the age and 
persistent (30 to 60 minutes) o bradycardia in children < 1 year old defined as a heart rate 
< 10 percent for the age (in absence of vagus nerve stimulation, β-blockers or congenital 
heart defect). 
3. Tachypnea defined as a respiratory frequency >2 standard deviation for the age or 
requirement of mechanical ventilation due to an acute process not related to an underlaying 
neuromuscular disease or secondary to general anesthesia. 
4. Recently started purulent sputum, or changes in the characteristics of the sputum, or an 
increase of respiratory secretions, or an increase in endotracheal aspiration needs. 
5. The starting or worsening of coughing, or of respiratory difficulties. 
6. Rales. 
7. Worsening of the blood gases exchange: Oxygenation index >3 or a drop of it in relation to 
previous measurements and/or a Kirby index <300 or a drop of it in relation to previous 
measurements. Both determinations indicate a worsening of respiratory functions. 
2. Patients aged 0 to 8 years old. 
3. A minimum HS of 72 hours. 
4. Having informed consent. 
5. Not having had previous RPP treatment. 
 
 
Deferral criteria: 
1. Presenting a fever state for more than three days. Performing physiotherapy increases the 
body’s peripheral temperature. 
2. Presenting an oxygen saturation below 80%. 
3. Requiring mechanical ventilation. 
4. Hemodynamic instability. 
5. Presenting systemic inflammatory response syndrome. 
6. Inotropic support. 
7. Anatomical variants in the thorax. 
8. Unstable thorax. 
9. Esophageal atresia. 
10. Pleural effusion, pneumothorax. 
11. Alterations that compromise respiratory centers and/or the phrenic nerve. 
12. Neuromuscular diseases that compromise respiratory mechanics. 
 
 
Elimination criteria: 
The existence of one or more of the following: 
1. Refusal to colaboration by the responsibleperson or patient. 
2. Barotrauma. 
3. Ascites (grave). 
4. Focal lung pneumatosis 
5. Pulmonary embolism (contraindication of the thoracic physiotherapy maneuvers). 
6. Tumors in the upper respiratory system, intra or extrathoracic. 
7. Glossitis. 
8. Immediate or mediate postoperative state of head, abdomen or thorax. 
9. Use of mechanical ventilation. 
10. Paient with cystic fibrosis 
2 
3 
4 
5 
2. Tachycardia (with no evident clinical cause) >2 standard deviation for the age and 
persistent (30 to 60 minutes) o bradycardia in children < 
1 year old defined as a heart rate 
<10 percent for the age (in absence of vagus nerve stimulation, B-blockers or congenital 
heart defect). 
3. Tachypnea defined as 
a respiratory frequency >2 standard deviation for the age 
or 
requirement of mechanical ventilation due to an acute process not related to an underlaying 
neuromuscular disease or secondary to general anesthesia. 
4. Recently started purulent sputum, or changes in the characteristics of the sputum, or an 
increase of respiratory secretions, or an increase in endotracheal aspiration needs. 
5. The starting or worsening of coughing, or of respiratory difficulties. 
6. Rales. 
7. Worsening of the blood gases exchange: Oxygenation index >3 or a drop of it in relation to 
previous measurements and/or a Kirby index <300 or a drop of 
it in relation to previous 
measurements. Both determinations indicate a worsening of respiratory functions. 
. Patients aged 0 to 8 years old. 
. Aminimum HS of 72 hours. 
. Having informed consent. 
. Not having had previous RPP treatment. 
Deferral criteria: 
1 
b 
Nh 
3 
4 
5. 
6 
7 
8 
9 
1 
1 
1 
. Presenting a fever state for more than three days. Performing physiotherapy increases the 
ody’s peripheral temperature. 
. Presenting an oxygen saturation below 80%. 
. Requiring mechanical ventilation. 
. Hemodynamic instability. 
Presenting systemic inflammatory response syndrome. 
. Inotropic support. 
. Anatomical variants in the thorax. 
. Unstable thorax. 
. Esophageal atresia. 
0. Pleural effusion, pneumothorax. 
1. Alterations that compromise respiratory centers and/or the phrenic nerve. 
2. Neuromuscular diseases that compromise respiratory mechanics. 
Elimination criteria: 
The existence of one or more of the following: 
1. 
2 
3 
4 
5 
6. 
7 
8 
9 
1 
Refusal to colaboration by the responsibleperson or patient. 
. Barotrauma. 
. Ascites (grave). 
. Focal lung pneumatosis 
. Pulmonary embolism (contraindication of the thoracic physiotherapy maneuvers). 
Tumors in the upper respiratory system, intra or extrathoracic. 
. Glossitis. 
. Immediate or mediate postoperative state of head, abdomen or thorax. 
. 
Use of mechanical ventilation. 
0. Paient with cystic fibrosis 
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Inervention group 
The intervention group (IG) will be subject to RPP. Techniques of slow expiration will be used 
(PSE and TP) and slow inspiration (CEFE) for the sweeping of secretions, during its expulsion 
forced expiratory techniques will be used (tracheal reflex). 
10 sessions will be performed, one a day from Monday to Friday, with a duration of 10 to 15 
minutes. 
 Intervention maneuvers 
RPP consists of two steps, 1.the sweeping or detachment of secretions and 2.the expulsion of 
the secretions. 
 
a. Prolonged slow expiration (PSE) 
It is a passive manual technique for expiratory support. A slow manual thoracoabdominal 
pressure is performed, which starts at the end of the spontaneous breathing up until the 
residual volume. Its purpose is to improve lung deflation, avoiding zones of bronchial 
narrowing, facilitating the depuration of the bronchopulmonary periphery. 
Positioning of the patient: Supine position, on a semi-hard surface.  
 Therapist’s: At one side of the patient. 
Maneuver: The cephalic proximity hand is placed on the manubrium of the sternum, and the 
caudal proximity hand under the xiphoid process. Manual gradual joint pressure is applied on 
the descending thoracic and abdominal zone at the end of the respiratory spontaneous time 
until reaching residual volume. *36 
 
b. Tracheal pumping (TP) 
Manual pressure is applied to the trachea, followed by a linear peristalsis movement from down 
to up, spreading a wave of pressure (pumping), at the same time a slight pressure is applied to 
the expiration simultaneous to the pumping. 
Positioning of the patient: Supine position, on a semi-hard surface.  
Therapist’s position: At one side of the patient. 
Maneuver: The patient is made to reach neck hyper-extension. Pressure is applied to the 
trachea using the thumb of the hand with the most cephalic proximity to the patient, an 
ascending movement is performed starting from the Jugular notch of the sternum to the cricoid 
cartilage. Abdominal pressure is applied during expiration using the most caudal hand to the 
patient. *36 
 
c. Controlled expiratory flow exercises (CEFE) 
This technique favors insufflation and the clearing of the Deep lung and the air spaces 
surrounding the inspiratory-dependent volume exchange zone. Its mechanical action is to 
stretch the lung parenchyma by means of a surrounding pleural depression. During the 
maneuver the air inspired through the pleurae in the periphery of the affliction penetrates the 
peripheral air spaces to be used during expiration time, freeing the bronchial network spaces 
that had been taken by the accumulation of secretions. *36, 38. 
 
d. Forced expiration technique (FET) 
Also accepted as the term expiratory flow acceleration (EFA). It is obtained by the energetic 
contraction of the expiratory muscles (mainly the abdominal ones). During the maneuver, the 
intrathoracic pressure of the oral discharge increases simultaneously, which produces a lower 
mouth discharge that that of coughing, that allows the tearing off of the secretions from the 
bronchial wall due to the apparition mechanism of the SPP (same pressure point). This 
situation responds to the function of viscosity, elasticity, mucus thickness, the level of adhesion 
to the bronchial wall and the flexibility of the bronchial wall. *36 
Inervention group 
The intervention group (IG) will be subject to RPP. Techniques of slow expiration will be used 
(PSE and TP) and slow inspiration (CEFE) for the sweeping of secretions, during its expulsion 
forced expiratory techniques will be used (tracheal reflex). 
10 sessions will be performed, one a day from Monday to Friday, with a duration of 10 to 15 
minutes. 
Intervention maneuvers 
RPP consists of two steps, 1.the sweeping or detachment of secretions and 2.the expulsion of 
the secretions. 
a. Prolonged slow expiration (PSE) 
It 
is 
a passive manual technique for expiratory support. A slow manual thoracoabdominal 
pressure 
is performed, which 
starts 
at the end 
of the spontaneous breathing 
up 
until the 
residual 
volume. 
Its 
purpose 
is 
to 
improve 
lung 
deflation, 
avoiding 
zones 
of 
bronchial 
narrowing, facilitating the depuration of the bronchopulmonary periphery. 
Positioning of the patient: Supine position, on a semi-hard surface. 
Therapist’s: At one side of the patient. 
Maneuver: The cephalic proximity hand 
is placed on the manubrium of the sternum, and the 
caudal proximity hand under the xiphoid process. Manual gradual joint pressure is applied on 
the descending thoracic and abdominal zone at the end of the respiratory spontaneous time 
until reaching residual volume. °° 
b. Tracheal pumping (TP) 
Manual pressure is applied to the trachea, followed by a 
linear peristalsis movement from down 
to up, spreading a wave of pressure (pumping), at the same time a slight pressure is applied to 
the expiration simultaneous to the pumping. 
Positioning of the patient: Supine position, on a semi-hard surface. 
Therapist’s position: At one side of the patient. 
Maneuver: The patient 
is made 
to reach neck hyper-extension. Pressure 
is applied 
to the 
trachea using 
the thumb 
of the hand with 
the most cephalic proximity 
to the 
patient, 
an 
ascending movement is performed starting from the Jugular notch of the sternum to the cricoid 
cartilage. Abdominal pressure is applied during expiration using the most caudal hand to the 
patient. 
c. Controlled expiratory flow exercises (CEFE) 
This technique favors insufflation and the clearing of the Deep lung and the air spaces 
surrounding the inspiratory-dependent volume exchange zone. 
Its mechanical action is to 
stretch the lung parenchyma by means of a surrounding pleural depression. During the 
maneuver the air inspired through the pleurae in the periphery of the affliction penetrates the 
peripheral air spaces to be used during expiration time, freeing the bronchial network spaces 
that had been taken by the accumulation of secretions. °° 3°: 
d. Forced expiration technique (FET) 
Also accepted as the term expiratory flow acceleration (EFA). 
It is obtained by the energetic 
contraction of the expiratory muscles (mainly the abdominal ones). During the maneuver, the 
intrathoracic pressure of the oral discharge increases simultaneously, which produces a lower 
mouth discharge that that of coughing, that allows the tearing off of the secretions from the 
bronchial 
wall due 
to the apparition mechanism 
of the SPP (same pressure 
point). This 
situation responds to the function of viscosity, elasticity, mucus thickness, the level of adhesion 
to the bronchial wall and the flexibility of the bronchial wall. °° 
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Control Group 
The control group (CG) will be subject to PD plus muscle belly compressions of the upper limbs 
for 10 sessions, one session a day from Monday to Friday, with a duration de 10 to 15 minutes 
per patient. Both groups will receive the usual treatment for pneumonia prescribed by their 
treating doctor. 
 
Variables and measuring instruments. 
Measurements will be performed before, and 15, 30 and 150 minutes after the maneuvers. 
Clinical severity will be measured using the Wang score (a modification of the Silverman score) 
(Table 3), which consists of 4 items: 
1. Respiratory rate. 
2. Wheezing. 
3. Retraction. 
4. General condition. 
 
Every item has an ordinal measurement level of 0 to 3 points (possible values: 0,1,2,3), 
excluding  general condition (with a value of 0 or 3 only). 
With a maximum summation of 12 points and a minimum of 0 points. The higher the score, the 
higher the clinical severity. 
 
Complementary measurements: 
1. Heart rate. 
2. SaO2. 
3. Lung occupancy in the x-ray that was taken when the diagnosis was made. 
 
The results from the pediatric Wang score (a modification of the Silverman score) will be 
compared in and between the groups at the following moments: 1.Before intervention (baseline 
state), 2.immediately after intervention, 3.15 minutes after intervention and 4.30 minutes after 
that. 
The following tool (anex 2) has been designed to measure the variables. The 
resources needed for research development are: 
1. Medical history. 
2. Vital signs monitors. 
3. Stethoscope. 
4. Pulse oximeter. 
5. Disposable latex gloves. 
6. Mechanical aspiration 
 
RESEARCH VARIABLES 
 
Independent variables 
1. Pediatric respiratory physiotherapy. 
2. Postural drainage plus muscle belly compressions to the upper limbs. 
 
Dependent variables 
1. Clinical severity. 
2. Days of hospital stay from the beginning of the pneumonia. 
 
Confounding variables 
1. Baseline disease. 
2. Age. 
3. Nutritional state. 
Control Group 
The control group (CG) will be subject to PD plus muscle belly compressions of the upper limbs 
for 10 sessions, one session a day from Monday to Friday, with a duration de 10 to 15 minutes 
per patient. Both groups will receive the usual treatment for pneumonia prescribed 
by their 
treating doctor. 
Variables and measuring instruments. 
Measurements will be performed before, and 
15, 30 and 150 minutes after the maneuvers. 
Clinical severity will be measured using the Wang score (a modification of the Silverman score) 
(Table 3), which consists of 4 items: 
1. Respiratory rate. 
2. Wheezing. 
3. Retraction. 
4. General condition. 
Every item has an ordinal measurement level of 0 to 
3 points (possible values: 0,1,2,3), 
excluding general condition (with a value of 0 or 3 only). 
With a maximum summation of 12 points and a minimum of 0 points. The higher the score, the 
higher the clinical severity. 
Complementary measurements: 
1. Heart rate. 
2. SaQo. 
3. Lung occupancy in the x-ray that was taken when the diagnosis was made. 
The 
results from 
the pediatric Wang score 
(a modification 
of the Silverman score) 
will 
be 
compared in and between the groups at the following moments: 1.Before intervention (baseline 
state), 2.immediately after intervention, 3.15 minutes after intervention and 4.30 minutes after 
that. 
The following 
tool 
(anex 
2) 
has been designed 
to measure 
the variables. The 
resources needed for research development are: 
1. Medical history. 
2. Vital signs monitors. 
3. Stethoscope. 
4. Pulse oximeter. 
5. Disposable latex gloves. 
6. Mechanical aspiration 
RESEARCH VARIABLES 
Independent variables 
1. Pediatric respiratory physiotherapy. 
2. Postural drainage plus muscle belly compressions to the upper limbs. 
Dependent variables 
1. Clinical severity. 
2. Days of hospital stay from the beginning of the pneumonia. 
Confounding variables 
1. Baseline disease. 
2. Age. 
3. Nutritional state. 
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Descriptive variables 
1. Sex. 
2. Reasons for check-in. 
3. Heart rate. 
4. Oxygen saturation (SaO2). 
5. Lung occupancy. 
6. Wang score. 
 
 
Variables 
Type 
Instrument 
Range 
Clinical severity.* 
Ordinal. 
Wang score. 
0-12 pts. 
Heart rate.* 
Discrete 
quantitative. 
Pulse oximeter. 
ChoiceMMed 
MD300C5. 
30bpm to 325bpm. 
SaO2.* 
Discrete 
quantitative. 
Pulse oximeter . 
ChoiceMMed 
MD300C5. 
0% to 100%. 
Lung occupancy.** 
Nominal. 
Simple X-ray of the 
thorax. 
Identification of the percentage 
occupied 
by 
secretions 
and 
infiltrates, 
detect 
complications
 
(atelectasis, 
effusion ,etc…). 
Days of hospital stay 
from the beginning of 
the pneumonia.** 
Discrete 
quantitative. 
Clinical file. 
0-180 days. 
Age.*** 
Discrete 
quantitative. 
Clinical file. 
1 to 6 years 364 days old. 
Sex.*** 
Nominal 
Clinical file. 
Masculine/femenine. 
Baseline disease. 
*** 
Nominal. 
Clinical file. 
Yes/No 
Specify. 
Reason for check-in.*** 
Nominal 
Clinical file. 
Specify. 
Complications 
of 
pneumonia from the 
momento 
of 
inclusion.*** 
Nominal. 
Clinical file. 
None/ Effusion/ Necrosis or 
pulmonary abscess/ Other 
(specify) 
 
*Measurements must be performed before intervention, immediately after, and 15, 30 and 150 minutes after. **Measurements will be performed before 
initiating treatment sessions and after they conclude. *** Measurements will be developed previously to the randomized group assignation. 
Descriptive variables 
1. Sex. 
2. Reasons for check-in. 
3. Heart rate. 
4. Oxygen saturation (SaO2). 
5. Lung occupancy. 
6. Wang score. 
  
  
  
  
  
  
  
  
  
  
  
 
Variables 
Type 
Instrument 
Range 
Clinical severity.* 
Ordinal. 
Wang score. 
0-12 pts. 
Heart rate.* 
Discrete 
Pulse oximeter. 
30bpm to 325bpm. 
quantitative. 
ChoiceMMed 
MD300C5. 
SaQz.* 
Discrete 
Pulse oximeter . 
0% to 100%. 
quantitative. 
ChoiceMMed 
MD300C5. 
Lung occupancy.** 
Nominal. 
Simple X-ray of the 
Identification 
of 
the 
percentage 
thorax. 
occupied 
by 
secretions 
and 
infiltrates, 
detect 
complications 
(atelectasis, 
effusion ,etc...). 
Days of hospital stay 
Discrete 
Clinical file. 
0-180 days. 
from the beginning of 
quantitative. 
the pneumonia.** 
Age.*** 
Discrete 
Clinical file. 
1 to 6 years 364 days old. 
quantitative. 
Sex.*** 
Nominal 
Clinical file. 
Masculine/femenine. 
Baseline disease. 
Nominal. 
Clinical file. 
Yes/No 
“ 
Specify. 
Reason for check-in.*** 
Nominal 
Clinical file. 
Specify. 
Complications 
of 
Nominal. 
Clinical file. 
None/ Effusion/ Necrosis or 
pneumonia 
from 
the 
pulmonary abscess/ Other 
momento 
of 
(specify) 
inclusion.*** 
 
 
 
 
  
*Measurements must be performed before intervention, immediately after, and 15, 30 and 150 minutes after. **Measurements will be performed before 
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initiating treatment sessions and after they conclude. *** Measurements will be developed previously to the randomized group assignation. 
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GENERAL DESCRIPTION OF THE STUDY 
Assessment prior to the study 
1. All patients diagnosed with pneumonia who comply with the selection criteria will be 
invited to participate in the study, in case of accepting, those older than 8 years old will 
verbally agree and will be given forms of informed consent to sign. 
2. Data obtained will be documented in a previously established data collection 
format (Anex 2). 
3. If there is no contraindication for the procedure, then the maneuver will be assigned. 
 
Initiation and evaluation of the assigned maneuver 
1. The researcher will perform the maneuver according to group assignation. 
2. Subsequently a collaborator, previously blinded to the maneuver and standardized 
for the Wang score (a modification of the Silverman score), will evaluate the Wang 
score 15, 30 and 150 minutes after its application. 
3. Another collaborator will do a follow-up on the patients in order to register their hospital 
stay time posterior to the diagnosis of pneumonia. 
4. The assigned maneuver will be performed once a day on the patient. 
 
End of study 
The study will end once the patient checks out of the hospital. 
 
Quality control 
The assessment of the efficiency will be performed by 2 collaborators blinded to the maneuver. 
One collaborator will assess the Wang score (a modification of the Silverman score), heart rate 
and SaO2 and the other collaborator will register the days of HS. 
 
DATA ANALYSIS PLAN 
Descriptive statistic: There will be an assessment of the central tendency values, relative 
dispersion and disposition to evaluate the descriptive variables at the start and at the end of the 
study in both groups, as well as the dependent variables after the intervention. 
Inferential statistic: 
1. The comparison in score of the descriptive variables in and between the groups will be 
performed using a Mann-Whitney U test. 
2. A 95% confidence Interval is estimated. 
 
The Wang score rates will be assessed in the measurements made before and immediately 
after the intervention, and 13, 30 and 150 minutes after. 
To describe the measurement differences and to reject or not the hypothesis, a Mann-Whitney U 
test will be used. 
 
LIMITATIONS OF THE STUDY 
Due to the maneuver condition, the subject cannot be blinded, and only the researchers will 
be single-blinded, which confers a type of bias to the study. 
GENERAL DESCRIPTION OF THE STUDY 
Assessment prior to the study 
1. 
All patients diagnosed with pneumonia who comply with the selection criteria will be 
invited to participate in the study, in case of accepting, those older than 8 years old will 
verbally agree and will be given forms of informed consent to sign. 
2. 
Data obtained will be documented in a previously established data collection 
format (Anex 2). 
3. 
If there is no contraindication for the procedure, then the maneuver will be assigned. 
Initiation and evaluation of the assigned maneuver 
1. 
The researcher will perform the maneuver according to group assignation. 
2. 
Subsequently a collaborator, previously blinded to the maneuver and standardized 
for the Wang score (a modification of the Silverman score), will evaluate the Wang 
score 15, 30 and 150 minutes after its application. 
3. 
Another collaborator will do a follow-up on the patients in order to register their hospital 
stay time posterior to the diagnosis of pneumonia. 
4. 
The assigned maneuver will be performed once a day on the patient. 
End of study 
The study will end once the patient checks out of the hospital. 
Quality control 
The assessment of the efficiency will be performed by 2 collaborators blinded to the maneuver. 
One collaborator will assess the Wang score (a modification of the Silverman score), heart rate 
and SaQz2 and the other collaborator will register the days of HS. 
DATA ANALYSIS PLAN 
Descriptive 
statistic: There 
will 
be 
an assessment 
of the 
central tendency values, 
relative 
dispersion and disposition to evaluate the descriptive variables at the start and at the end of the 
studyin both groups, as well as the dependent variables after the intervention. 
Inferential statistic: 
1. The comparison in score of the descriptive variables in and between the groups will be 
performed using a Mann-Whitney U test. 
2. A 95% confidence Interval is estimated. 
The Wang score rates will be assessed in the measurements made before and immediately 
after the intervention, and 13, 30 and 150 minutes after. 
To describe the measurement differences and to reject or not the hypothesis, a Mann-Whitney U 
test will be used. 
LIMITATIONS OF THE STUDY 
Due to the maneuver condition, the subject cannot be blinded, and only the researchers will 
be single-blinded, which confers a type of bias to the study. 
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TIMELINE 
The timeline of activities is presented as a FORMAT ATTACHED to this document. 
 
 
ETHICAL CONSIDERATIONS 
The 2016 guide for the evaluation of ethical considerations of our institution is presented as a 
FORMAT ATTACHED to this document. 
 
Beneficence/Nonmaleficence 
This is a MAXIMUM TO MINIMAL RISK study for participants, and it could cause reflux, vomit or 
irritability of the patient’s emotional state (with all that implies). Potential benefit to the patient by 
improving their clinical severity and reducing the days of hospital stay. Potential Benefit to 
society by reducing the days of hospital stay, which in turn will reduce the cost of treatment for 
children with pneumonia. 
 
Autonomy and respect 
It will be clearly expressed to the patient or person responsible for them, every procedure they 
will become subject to, until their understanding is secured. 
 
A Form of Informed Consent will be required (Anex 3). 
 
 
We consider that due to the participants’ ages it is not possible to require a Form of Informed 
Assent. 
 
The anonymity of participants will be maintained, and the confidentiality of data will be 
maintained using a restricted database to which only the researchers have access to. 
Justice: The participant population is in a vulnerable situation since they are minors. 
Nevertheless, the adult population is well enough informed and the results of this study seek to 
improve the care of this sector of the population. 
 
The norms and standards for bioethics from the declaration of Helsinki have been considered, 
as well as the legal and juridical regimes for research current on Mexico (General Law of Health 
in Regard of Research in Human Beings).  
TIMELINE 
The timeline of activities is presented as a FORMAT ATTACHED to this document. 
ETHICAL CONSIDERATIONS 
The 2016 guide for the evaluation of ethical considerations of our institution 
is presented as a 
FORMAT ATTACHED to this document. 
Beneficence/Nonmaleficence 
This is a MAXIMUM TO MINIMAL RISK study for participants, and 
it could cause reflux, vomit or 
irritability of the patient’s emotional state (with all that implies). Potential benefit to the patient by 
improving their clinical severity and reducing the days 
of hospital 
stay. 
Potential 
Benefit to 
society by reducing the days of hospital stay, which in turn will reduce the cost of treatment for 
children with pneumonia. 
Autonomy and respect 
It will be clearly expressed to the patient or person responsible for them, every procedure they 
will become subject to, until their understanding is secured. 
A Form of Informed Consent will be required (Anex 3). 
We consider that due to the participants’ ages 
it is not possible to require a Form of Informed 
Assent. 
The anonymity 
of 
participants 
will 
be 
maintained, 
and 
the 
confidentiality 
of data 
will 
be 
maintained using a restricted database to which only the researchers have access to. 
Justice: 
The 
participant 
population 
is 
in 
a 
vulnerable 
situation 
since 
they 
are 
minors. 
Nevertheless, the adult population is well enough informed and the results of this study seek to 
improve the care of this sector of the population. 
The norms and standards for bioethics from the declaration of Helsinki have been considered, 
as well as the legal and juridical regimes for research current on Mexico (General Law of Health 
in Regard of Research in Human Beings). 
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BIOSECURITYCONSIDERATIONS 
This research project does not have biosecurity implications, since no pathogenic agents or 
potential pathogens are handled. 
The form from the biosecurity committee of our nation is presented as a FORMAT ATTACHED 
to this document. 
 
PRODUCTS TO BE OBTAINED FROM THE STUDY 
Assuming that the biostatistical results gathered do not reject the hypothesis, it is intended 
to divulge the results by elaborating a scientific poster and presenting it in various 
congresses and update conferences. 
 
The following events are contemplated to divulge the results: 
1. IIV Conferencia de actualización en pediatría. ALEPE. 2017. 
2. 76° Congreso de las Américas de Neumología y Cirugía de Tórax. Sociedad Mexicana 
de Neumología y Cirugía de Tórax. 2017. 
3. XVI International Congress on Pediatric Pulmonology. CIPP. 2017. 
4. 49° Congreso Nacional SEPAR. 2017. 
5. LXIV Congreso de la Asociación de Médicos del Hospital Infantil. 2017. 
6. VII Congreso de SEFIP. 2017. 
 
 
BIBLIOGRAPHIC REFERENCES 
[1] Girardi G, et al. El Programa IRA en Chile: hitos e historia. [IRA program in Chile: milestones and history] Chil Ped 
(Chil). 2001; 72: 292-300. 
 
[2] Ministerio de Salud. Programa Nacional de Prevención y Manejo de Infecciones Respiratorias Agudas 
del Niño. [Ministry of Health. National Program for the Prevention and Handling of Acute Respiratory 
Infections in a Child] Chile: Gob Chil; 2007. 
[3] Postiaux G, Hankard R, Saulnier JP, Karolewicz S, Binielli J, Le Dinahet T.La kinésithérapie dans la 
bronchiolite du nourrisson: faut-il vraiment abandonner? [Physiotherapy in Bronchiolitis in Infants: 
Should We Really Give Up?] Arc Ped (Fra). 2014; 21:452-53. 
[4] European Respiratory Society Annual Congress. Effects of a new chest physiotherapy protocol in infant 
RSV bronchiolitis; 4-8 october. Berlín: European Respiratory Society; 2008. 
[5] Gajdos V, et al. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a 
multicenter, randomized, controlled trial. Plos Med (EUA). 2010; 7(9):1–11. 
[6] Güell Rous MR, Díez Betoret JL, Sanchis Aldas J. Rehabilitación respiratoria y fisioterapia respiratoria. 
Un buen momento para su impulso. [Respiratory Rehabilitation and Respiratory Physiotherapy. A Good 
Time to Promote It]  Arch Bron (Bar). 2008;44(1):35-40. 
BIOSECURITYCONSIDERATIONS 
This research project does not have biosecurity implications, since no pathogenic agents or 
potential pathogens are handled. 
The form from the biosecurity committee of our nation is presented as a FORMAT ATTACHED 
to this document. 
PRODUCTS TO BE OBTAINED FROM THE STUDY 
Assuming that the biostatistical results gathered do not reject the hypothesis, 
it is intended 
to divulge 
the 
results 
by elaborating 
a 
scientific poster and 
presenting 
it 
in various 
congresses and update conferences. 
The following events are contemplated to divulge the results: 
1. 
IIV Conferencia de actualizacion en pediatria. ALEPE. 2017. 
2. 
76° Congreso de las Américas de Neumologia y Cirugia de Térax. Sociedad Mexicana 
de Neumologia y Cirugia de Torax. 2017. 
3. XVI International Congress on Pediatric Pulmonology. CIPP. 2017. 
4. 49° Congreso Nacional SEPAR. 2017. 
5. 
LXIV Congreso de la Asociacién de Médicos del Hospital Infantil. 2017. 
6. 
VIl Congreso de SEFIP. 2017. 
BIBLIOGRAPHIC REFERENCES 
[1] Girardi G, et al. El Programa IRA en Chile: hitos e historia. [IRA program in Chile: milestones and history] Chil Ped 
(Chil). 2001; 72: 292-300. 
[2] Ministerio de Salud. Programa Nacional de Prevencion y Manejo de Infecciones Respiratorias Agudas 
del Nifio. [Ministry of Health. National Program for the Prevention and Handling of Acute Respiratory 
Infections in a Child] Chile: Gob Chil; 2007. 
[3] Postiaux G, Hankard R, Saulnier JP, Karolewicz S, Binielli J, Le Dinahet T.La kinésithérapie dans la 
bronchiolite du nourrisson: faut-il vraiment abandonner? [Physiotherapy in Bronchiolitis in Infants: 
Should We Really Give Up?] Arc Ped (Fra). 2014; 21:452-53. 
[4] European Respiratory Society Annual Congress. Effects of a new chest physiotherapy protocol in infant 
RSV 
bronchiolitis; 4-8 october. Berlin: European Respiratory Society; 2008. 
[5] Gajdos V, et al. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a 
multicenter, randomized, controlled trial. Plos Med (EUA). 2010; 7(9):1—11. 
[6] Guell Rous MR, Diez Betoret JL, Sanchis Aldas J. Rehabilitacidn respiratoria y fisioterapia respiratoria. 
Un buen momento para su impulso. [Respiratory Rehabilitation and Respiratory Physiotherapy. A Good 
Time to Promote It] Arch Bron (Bar). 2008;44(1):35-40. 
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[7] Barben J, Kuehni CE, Trachsel D, Hammer J. Management of acute bronchiolitis: can evidence based 
guidelines alter clinical practice?. Thorax (Lond). 2008;63:1103–9. 
[7] Barben J, Kuehni CE, Trachsel D, Hammer J. Management of acute bronchiolitis: can evidence based 
guidelines alter clinical practice?. Thorax (Lond). 2008;63:1103-9. 
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[8] González J, Ochoa C. Estudio de variabilidad en el abordaje de la bronquiolitis aguda en España en 
relación con la edad de los pacientes. [Variavility Study of the Approach to Acute Bronchiolitis in Spain 
with Relation to the Patient’s Ages] Anales de Ped (Bar). 2010;72(1):4–18. 
 
[9] Bohe L, et al. Indications of conventional chest physiotherapy in acute bronchiolitis. Med Buen Air (Argt). 
2004;64(3): 198–200. 
[10] De Córdoba F, et al. Fisioterapia respiratória em lactentes com bronquiolite: realizar ou não?. 
[Respiratory Physiotherapy on Nursing Babies With Bronchiolitis: Perform or Not?] Mun Saú (Braz). 
2008;32(2):183-8. 
[11] Aviram M, et al. Chest physiotherapy in acute bronchiolitis [Abstract]. Euro Resp Jour (Suiza). 
1992;5:229–30. 
[12] Webb MS, Martin JA, Cartlidge PH, Wright NA. Chest physiotherapy in acute bronchiolitis. ADC (Gran 
Bret). 1985;60:107-89. 
[13] Nicholas KJ, Dhouieb MO, Marshal TG, Edmunds AT, Grant MB. An evaluation of chest physiotherapy 
in the management of acute bronchiolitis. Changing clinical practice. Physiotherapy. Elsevier (Esp). 
1999;85(12):669–74. 
[14] Torres G. Avances de las enfermedades respiratorias pediátricas. 1ª ed. [Advances in Pediatric 
Respiratory Diseases, 1st ed.] México: Medicina y Mercadotecnia; 2014. 
[16] Figuls M, Giné-Garriga M, Granados Rugeles C, et al. Chest physiotherapy for acute bronchiolitis in 
pediatric patients between 0 and 24 months old (Review). John Wiley & Sons. 2016 Feb 1 2 [Cochrane 
Database ahead of print]. 
[17] Joud M, et al. La kinésithérapie est-elle toujours la pierre angulaire du traitement? [Is Physiotherapy 
Still the Cornerstone od Treatment?] Arc Ped (Fra). 2014;21:228-29. 
[18] Chavez GS, et al. Chest physiotherapy for pneumonia in children. John Wiley & Sons (Braz). 2015;1-10. 
 
[19] Lukrafka JL, et al. Chest physiotherapy in pediatric patients hospitalized with community-acquired 
pneumonia: a randomised clinical trial. ADC (Lond). 2012;97:967-71. 
[20] Paludo C, et al. Chest physical therapy for children hospitalized with acute pneumonia: a randomized 
controlled trial. Thorax (Lond ). 2008; 63: 791-94. 
[21] Zhao S. Análisis clínico de 47 casos de tratamiento con presión positiva continua en la vía aérea nasal 
de los niños con neumonía grave. [Clinical Analysis of 47 Cases Treated With Continuous Positive 
Pressure in the Nasal Airway in Children With Severe Pneumonia] Chin J Cont Ped (Chin). 2010; 12(3): 
226. 
[22] Torres, A. Infecciones respiratorias en UCI. 1ª ed. [Respiratory Infections in the UCI. 1st ed.] Barcelona: Springer-
Verlag Ibérica; 2012. 
 
[23] Avila FC et al. Prevalencia de infecciones nosocomiales en niños: encuesta de 21 hospitales en México. 
[Prevalence of Nosocomial Infections in Children: Survey to 21 Hospitals From Mexico] Sal Pub Mex. 
1999; 41(1):18-25. 
[24] Reyes, M., Duque, G., y Quevedo, F. Neumología Pediátrica. Infección, alergia y enfermedad 
[8] Gonzdlez J, Ochoa C. Estudio de variabilidad en el abordaje de la bronquiolitis aguda en Espafia en 
relacion con la edad de Ios pacientes. [Variavility Study of the Approach to Acute Bronchiolitis in Spain 
with Relation to the Patient’s Ages] Anales de Ped (Bar). 2010; 72(1):4—18. 
[9] Bohe L, et al. Indications of conventional chest physiotherapy in acute bronchiolitis. Med Buen Air (Argt). 
2004;64(3): 198-200. 
[10] De Cordoba 
F, 
et 
al. Fisioterapia respiratoria em lactentes com bronquiolite: realizar ou ndo?. 
[Respiratory Physiotherapy on Nursing Babies With Bronchiolitis: Perform 
or Not?] Mun Sau (Braz). 
2008;32(2):183-8. 
[11] Aviram M, 
et 
al. 
Chest physiotherapy 
in acute bronchiolitis [Abstract]. 
Euro Resp Jour (Suiza). 
1992;5:229-30. 
[12] Webb MS, Martin JA, Cartlidge PH, Wright NA. Chest physiotherapy in acute bronchiolitis. ADC (Gran 
Bret). 1985;60:107-89. 
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