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

NCT06174454 | Completed DMC

• 1 other identifier: HIM2017-055 SSA1376
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia Childhood; Rehabilitation; Recovery of Function

Keywords

Pneumonia; Respiratory Pediatric Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hospital stay

  7 days

Study Arms (2)

Inervention group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Respiratory Pediatric Physiotherapy OTHER

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

Also known as: Fisioterapia torácica pediatrica

Inervention group

Control Group OTHER

Will be subject to muscle compressions of the upper limbs. Both groups will receive the usual treatment for pneumonia prescribed by their treating doctor.

Control Group

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Hospital Infantil de México Federico Gómez

Mexico City, Delegación Cuauhtémoc, 06720, Mexico

Location

Related Publications (3)

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24721416 RESULT

MeSH Terms

Conditions

Pneumonia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Adrian Morales, Fisioterapia

  Hospital Infantil de Mexico Federico Gomez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: December 18, 2023
• Study Start: February 3, 2018
• Primary Completion: August 4, 2023
• Study Completion: November 4, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)