Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia: Single-Blind Clinical Trial

Conditions
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Pneumonia Childhood, Rehabilitation, Recovery of Function

Intervention / Treatment
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* Other: Respiratory Pediatric Physiotherapy
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients from the Hospital Infantil de México Federico Góme with diagnosis of pneumonia (considering the diagnostic criteria of the WHO and the Guidelines for Nosocomial Pneumonia from the infectiology department. Patients aged 0 to 8 years old. A minimum HS of 72 hours. Having informed consent. Not having had previous RPP treatment. Exclusion Criteria: Presenting a fever state for more than three days. Performing physiotherapy increases the body'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. Pleural effusion, pneumothorax. Alterations that compromise respiratory centers and/or the phrenic nerve. Neuromuscular diseases that compromise respiratory mechanics.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The population will consist of children aged from 0 to 8 years old diagnosed with pneumonia with a development time less than 7 days. he 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inervention group<br>The intervention group will be subject to RPP. Techniques of slow expiration will be used and slow inspiration 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. | Other: Respiratory Pediatric Physiotherapy<br>* Prolonged slow expiration Tracheal pumping Controlled expiratory flow exercises Forced expiration technique<br>* Other names: Fisioterapia torácica pediatrica;|
| Placebo Comparator: Control Group<br>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. | Other: Control Group<br>* Will be subject to muscle compressions of the upper limbs. Both groups will receive the usual treatment for pneumonia prescribed by their treating doctor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory difficulty | The Silverman score will be used with a range of 0 to 10 points, directly proportional between the sum and the respiratory difficulty. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Days of hospital stay | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Respiratory Pediatric Physiotherapy