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Completed

NCT Number: NCT06349785

Manual Hyperinflation and Physical Therapy Program on Lung Recruitment Mechanically Ventilated Pediatric Patients

The purpose of this study is to investigate the immediate combined effects of Manual Hyperinflation and standard Physical therapy program on lung recruitment and secretion mass in mechanically ventilated pediatric patients aged between 10-15 years 'old

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Key information

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Medicine

Ismailia, 41522, Egypt

About this study

In developing countries, lower respiratory tract infection is a major cause of death in children, with severely ill patients being admitted to the critical-care unit. While physical therapists commonly use the manual hyperinflation (MHI) technique for secretion mass clearance in critical-care patients, its efficacy has not been determined in pediatric patients.

Manual hyperinflation is a frequently maneuver used in critically ill intubated and mechanically ventilated patients. With MHI, patients are disconnected from the mechanical ventilator after which their lungs are temporarily ventilated with a manual ventilation bag. so, by applying a larger than normal volume at a low inspiratory pause and expiration with a high expiratory flow, MHI is suggested to mimic a normal cough.

Propagation of airway secretions from the smaller toward the larger airways, then allows for easy removed of airway secretions with the airway suction. finally, MHI could prevent airway plugging and even promote alveolar recruitment. so the aim of the study is to enhance lung recruitment using MHI combined with standard Physical therapy program

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patients will be aged 10-15 years,
  • receiving mechanical ventilation via an endotracheal tube for at least 24 h
  • presenting with vital signs in the normal range.
  • All patients are suffering from lower respiratory tract infection like pneumonia, bronchitis and acute exacerbation of bronchiectasis

Exclusion criteria

  • Patients with history of thoracic surgery
  • Patients with pneumothorax or acute respiratory distress syndrome
  • Patients with severe acute head injury
  • Patients use inotropes and vasopressors drugs
  • Patients with severe Broncho pleural fistula, rib fracture, emphysema bullae, lung abscess, patients with history of preterm birth or heart disease.
  • Patients who requiring mechanical ventilation with a peak inspiratory pressure (PIP)

Treatment and study plan

rehabilitation of mechanically ventilated patients

Device
  • mechanical ventilation
  • silicon resuscitation bag (500ml) connected to pressure manometer with an oxygen flow of 10 l.min-1
  • Endotracheal closed suction with pressure control ventilation (PCV)

Other names: rehabilitation by using combined physical therapy and manual hyperinflation

Supportive Care

Procedure
  • Children in study group B will receive standard Physical therapy program including suction, percussion and vibration with total duration of session in group a will be 15 minutes, daily for successive two weeks

Other names: physical therapy for pediatric respiratory disorders

Primary outcomes

  1. change the respiratory functions

    Time frame: 2 weeks

    By increasing tidal volume

  2. change the respiratory mechanics

    Time frame: 2 weeks

    increasing inspiratory capacity

  3. change the bronchospasm

    Time frame: 2 weeks

    modifying mean airway pressure

  4. change the amount of ventilation

    Time frame: 2 weeks

    increasing the oxygen saturation

Secondary outcomes

  1. decreasing the amount of secretions

    Time frame: 2 weeks

    by monitoring the change of amount of secretions collection calibrated tube attached to a closed suction system to calculate the secretion mass before and after treatment using: Suction by Endotracheal closed suction with pressure control ventilation (PCV) will be performed. The duration of suction was 10 s with 5-s rest for each set. Three sets of suction with a closed suction system will be used for both groups of patients.

  2. weaning from mechanical ventilator

    Time frame: from 2 to 4 weeks

    by improving previously mentioned respiratory function

Sponsors and collaborators

Lead sponsor

New Ismailia National University

Other

Registry information

Official study title

Effect of Combined Manual Hyperinflation and Standard Physical Therapy Program on Lung Recruitment in Mechanically Ventilated Pediatric Patients: A Randomized Clinical Trial

Acronym: MHI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2024
Registry last updated
Apr 5, 2024

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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