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

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

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Recovery of Function; Pneumonia Childhood
• Intervention / Treatment: Other: Respiratory Pediatric Physiotherapy; Other: Control Group

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Delegación Cuauhtémoc
    • Ciudad de mexico, Delegación Cuauhtémoc, Mexico, 06720
      • Hospital Infantil de Mexico Federico Gomez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inervention group; 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; Prolonged slow expiration Tracheal pumping Controlled expiratory flow exercises Forced expiration technique; Other Names: Fisioterapia torácica pediatrica
Placebo Comparator: Control Group; 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; Will be subject to muscle compressions of the upper limbs. Both groups will receive the usual treatment for pneumonia prescribed by their treating doctor.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Infantil de Mexico Federico Gomez
• Investigators: Principal Investigator: Adrian Morales, Fisioterapia, Hospital Infantil de Mexico Federico Gomez

Publications and helpful links

General Publications

• Girardi G, et al. El Programa IRA en Chile: hitos e historia. Chil Ped (Chil). 2001; 72: 292-300.
• European Respiratory Society Annual Congress. Effects of a new chest physiotherapy protocol in infant RSV bronchiolitis; 4-8 october. Berlín: European Respiratory Society; 2008.
• Postiaux G, Hankard R, Saulnier JP, Karolewicz S, Binielli J, Le Dinahet T.La kinésithérapie dans la bronchiolite du nourrisson: faut-il vraiment abandonner? Arc Ped (Fra). 2014; 21:452-53.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2018
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): November 4, 2023

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pneumonia; Respiratory Pediatric Physiotherapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: HIM2017-055 SSA1376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No