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OpenTrials
Completed

NCT Number: NCT06174454

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

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.

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Key information

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Infantil de México Federico Gómez

Mexico City, Delegación Cuauhtémoc, 06720, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Respiratory Pediatric Physiotherapy

Other

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

Other names: Fisioterapia torácica pediatrica

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.

Primary outcomes

  1. Respiratory difficulty

    Time frame: 5 days

    The Silverman score will be used with a range of 0 to 10 points, directly proportional between the sum and the respiratory difficulty.

Secondary outcomes

  1. Hospital stay

    Time frame: 7 days

    Days of hospital stay

Sponsors and collaborators

Lead sponsor

Hospital Infantil de Mexico Federico Gomez

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 18, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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