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

NCT ID: NCT06349785

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2024-03-29

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

Conditions

Mechanical Ventilation Complication; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

rehabilitation of mechanically ventilated patients

Intervention Type: DEVICE

1. mechanical ventilation

2. silicon resuscitation bag (500ml) connected to pressure manometer with an oxygen flow of 10 l.min-1

3. Endotracheal closed suction with pressure control ventilation (PCV)

supportive care

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

supportive care

Intervention Type: 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

Interventions

rehabilitation of mechanically ventilated patients

1. mechanical ventilation

2. silicon resuscitation bag (500ml) connected to pressure manometer with an oxygen flow of 10 l.min-1

3. Endotracheal closed suction with pressure control ventilation (PCV)

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

Other Intervention Names

rehabilitation by using combined physical therapy and manual hyperinflation; physical therapy for pediatric respiratory disorders

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Ismailia National University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdel Moeim Abo EL Ros

Lecturer of Physical Therapy for Pediatrics and its Surgeries

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr K Abo Takia, MD

Role: STUDY_DIRECTOR

college of medicine Suez Canal University

Locations

College of Medicine

Ismailia, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 29754124 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/29754124/

open access article from national library of medicine

Other Identifiers

P.T.REC/012/003858

Identifier Type: -

Identifier Source: org_study_id