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

NCT ID: NCT06174454

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-03

Study Completion Date

2023-11-04

Brief Summary

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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

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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.

Conditions

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Pneumonia Childhood Rehabilitation Recovery of Function

Keywords

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Pneumonia Respiratory Pediatric Physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Respiratory Pediatric Physiotherapy

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type 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.

Interventions

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Respiratory Pediatric Physiotherapy

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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Fisioterapia torácica pediatrica

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Infantil de Mexico Federico Gomez

OTHER

Sponsor Role lead

Responsible Party

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Adrian Morales Muñoz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian Morales, Fisioterapia

Role: PRINCIPAL_INVESTIGATOR

Hospital Infantil de Mexico Federico Gomez

Locations

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Hospital Infantil de México Federico Gómez

Mexico City, Delegación Cuauhtémoc, Mexico

Site Status

Countries

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Mexico

References

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

Reference Type 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.

Reference Type 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.

Reference Type RESULT
PMID: 24721416 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HIM2017-055 SSA1376

Identifier Type: -

Identifier Source: org_study_id