Clinical trial NCT06349785: Manual Hyperinflation and Physical Therapy Program on Lung Recruitment Mechanically Ventilated Pediatric Patients
Official title: Effect of Combined Manual Hyperinflation and Standard Physical Therapy Program on Lung Recruitment in Mechanically Ventilated Pediatric Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Physical Disability
Keywords: MHI, Physical Therapy, Mechanically ventilated patients
Lead sponsor: New Ismailia National University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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

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)

Primary outcomes:
measure: change the respiratory functions
timeFrame: 2 weeks
measure: change the respiratory mechanics
timeFrame: 2 weeks
measure: change the bronchospasm
timeFrame: 2 weeks
measure: change the amount of ventilation
timeFrame: 2 weeks
Secondary outcomes:
measure: decreasing the amount of secretions
timeFrame: 2 weeks
measure: weaning from mechanical ventilator
timeFrame: from 2 to 4 weeks
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: College of Medicine
Study officials:
affiliation: college of medicine Suez Canal University
name: Amr K Abo Takia, MD
role: STUDY_DIRECTOR
References:
citation: 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.