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Clinical Trials/NCT06349785
NCT06349785
Completed
Not Applicable

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

New Ismailia National University1 site in 1 country32 target enrollmentDecember 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation Complication
Sponsor
New Ismailia National University
Enrollment
32
Locations
1
Primary Endpoint
change the respiratory functions
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
December 20, 2023
End Date
March 29, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
New Ismailia National University
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Abdel Moeim Abo EL Ros

Lecturer of Physical Therapy for Pediatrics and its Surgeries

New Ismailia National University

Eligibility Criteria

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)

Outcomes

Primary Outcomes

change the respiratory functions

Time Frame: 2 weeks

By increasing tidal volume

change the respiratory mechanics

Time Frame: 2 weeks

increasing inspiratory capacity

change the bronchospasm

Time Frame: 2 weeks

modifying mean airway pressure

change the amount of ventilation

Time Frame: 2 weeks

increasing the oxygen saturation

Secondary Outcomes

  • decreasing the amount of secretions(2 weeks)
  • weaning from mechanical ventilator(from 2 to 4 weeks)

Study Sites (1)

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