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

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication; Physical Disability
• Interventions: Device: rehabilitation of mechanically ventilated patients; Procedure: supportive care

• Registration Number: NCT06349785
• Lead Sponsor: New Ismailia National University

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

Study Timeline

• Study Start: 2023-12-20
• Primary Completion: 2024-03-01
• Study First Submitted: 2024-03-23
• Study Completion: 2024-03-29
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group A	supportive care	Assigned Children in the study will receive manual hyperinflation and standard physical therapy program. Manual hyperinflation (MHI): Manual hyperinflation will be performed by single physical therapist using a silicone resuscitator bag . The resuscitator bag (maximum volume of 500 mL) was connected to a pressure manometer with an oxygen flow of 10 L. min-1 with the total duration of session in group A will be 15 minutes, daily for 2 weeks
study group B	supportive care	- 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 2 weeks
study group A	rehabilitation of mechanically ventilated patients	Assigned Children in the study will receive manual hyperinflation and standard physical therapy program. Manual hyperinflation (MHI): Manual hyperinflation will be performed by single physical therapist using a silicone resuscitator bag . The resuscitator bag (maximum volume of 500 mL) was connected to a pressure manometer with an oxygen flow of 10 L. min-1 with the total duration of session in group A will be 15 minutes, daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
change the respiratory functions	2 weeks	By increasing tidal volume
change the respiratory mechanics	2 weeks	increasing inspiratory capacity
change the bronchospasm	2 weeks	modifying mean airway pressure
change the amount of ventilation	2 weeks	increasing the oxygen saturation

Secondary Outcome Measures

Name	Time	Method
decreasing the amount of secretions	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.
weaning from mechanical ventilator	from 2 to 4 weeks	by improving previously mentioned respiratory function

Trial Locations

Locations (1)

College of Medicine; 🇪🇬 Ismailia, Egypt