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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06174454
• Other study ID #: HIM2017-055 SSA1376
• Status: Completed
• Phase: N/A
• Start date: February 3, 2018
• Est. completion date: November 4, 2023

Study information

• Verified date: December 2023
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia Childhood
• Recovery of Function
• Rehabilitation

Intervention

Other:
• Respiratory Pediatric Physiotherapy
Prolonged slow expiration Tracheal pumping Controlled expiratory flow exercises Forced expiration technique
• 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.

Locations

Country	Name	City	State
Mexico	Hospital Infantil de México Federico Gómez	Ciudad de mexico	Delegación Cuauhtémoc

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

European Respiratory Society Annual Congress. Effects of a new chest physiotherapy protocol in infant RSV bronchiolitis; 4-8 october. Berlín: European Respiratory Society; 2008.

Girardi G, et al. El Programa IRA en Chile: hitos e historia. Chil Ped (Chil). 2001; 72: 292-300.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital stay	Days of hospital stay	7 days