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

NCT06349785 | Completed

• 1 other identifier: P.T.REC/012/003858
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Mechanical Ventilation Complication; Physical Disability

Keywords

MHI, Physical Therapy, Mechanically ventilated patients

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• decreasing the amount of secretions

  2 weeks

• weaning from mechanical ventilator

  from 2 to 4 weeks

Study Arms (2)

study group A

EXPERIMENTAL

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; Procedure: supportive care

study group B

ACTIVE COMPARATOR

\- 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

Interventions

rehabilitation of mechanically ventilated patients 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)

Also known as: rehabilitation by using combined physical therapy and manual hyperinflation

study group A

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

Also known as: physical therapy for pediatric respiratory disorders

study group A; study group B

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• New Ismailia National University: lead

Study Sites (1)

College of Medicine

Ismailia, 41522, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29754124 BACKGROUND

Related Links

• open access article from national library of medicine

MeSH Terms

Interventions

Palliative Care; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Rehabilitation

Study Officials

• Amr K Abo Takia, MD

  college of medicine Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: using sealed envelopes,
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy for Pediatrics and its Surgeries

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 5, 2024
• Study Start: December 20, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 29, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)