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

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

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

Study Overview

• Status: Completed
• Conditions: Physical Disability; Mechanical Ventilation Complication
• Intervention / Treatment: Device: rehabilitation of mechanically ventilated patients; Procedure: supportive care

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 41522
    • College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group A; 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	Device: rehabilitation of mechanically ventilated patients; 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; Procedure: 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 successive two weeks; Other Names: physical therapy for pediatric respiratory disorders
Active Comparator: study group B; - 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	Procedure: 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 successive two weeks; Other Names: physical therapy for pediatric respiratory disorders

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decreasing the amount of secretions	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 weeks
weaning from mechanical ventilator	by improving previously mentioned respiratory function	from 2 to 4 weeks

Collaborators and Investigators

• Sponsor: New Ismailia National University
• Investigators: Study Director: Amr K Abo Takia, MD, college of medicine Suez Canal University

Publications and helpful links

General Publications

• Ubeda Tikkanen A, Nathan M, Sleeper LA, Flavin M, Lewis A, Nimec D, Mayer JE, Del Nido P. Predictors of Postoperative Rehabilitation Therapy Following Congenital Heart Surgery. J Am Heart Assoc. 2018 May 12;7(10):e008094. doi: 10.1161/JAHA.117.008094.

Helpful Links

• open access article from national library of medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: MHI, Physical Therapy, Mechanically ventilated patients
• Other Study ID Numbers: P.T.REC/012/003858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will not be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No