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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06174454
Enrollment
88
Registered
2023-12-18
Start date
2018-02-03
Completion date
2023-11-04
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia Childhood, Recovery of Function, Rehabilitation

Keywords

Pneumonia, Respiratory Pediatric Physiotherapy

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.

Interventions

OTHERRespiratory Pediatric Physiotherapy

Prolonged slow expiration Tracheal pumping Controlled expiratory flow exercises Forced expiration technique

OTHERControl 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.

Sponsors

Hospital Infantil de Mexico Federico Gomez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

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.

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

Eligibility

Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory difficulty5 daysThe Silverman score will be used with a range of 0 to 10 points, directly proportional between the sum and the respiratory difficulty.

Secondary

MeasureTime frameDescription
Hospital stay7 daysDays of hospital stay

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026