Clinical trial NCT06174454: Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia
Official title: Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia: Single-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia Childhood
Rehabilitation
Recovery of Function
Keywords: Pneumonia
Respiratory Pediatric Physiotherapy
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 88
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion criteria:

1. 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.
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.

Exclusion 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.

Primary outcomes:
measure: Respiratory difficulty
timeFrame: 5 days
Secondary outcomes:
measure: Hospital stay
timeFrame: 7 days
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Hospital Infantil de México Federico Gómez
state: Delegación Cuauhtémoc
Study officials:
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Adrian Morales, Fisioterapia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Girardi G, et al. El Programa IRA en Chile: hitos e historia. Chil Ped (Chil). 2001; 72: 292-300.
citation: European Respiratory Society Annual Congress. Effects of a new chest physiotherapy protocol in infant RSV bronchiolitis; 4-8 october. Berlín: European Respiratory Society; 2008.
citation: Postiaux G, Hankard R, Saulnier JP, Karolewicz S, Benielli J, Le Dinahet T, Louis J. Chest physical therapy in infant acute viral bronchiolitis: should we really surrender? Arch Pediatr. 2014 May;21(5):452-3. doi: 10.1016/j.arcped.2014.02.029. Epub 2014 Apr 8. No abstract available.