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

Mechanical Ventilation Complication Clinical Trial

— MHI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06349785
• Other study ID #: P.T.REC/012/003858
• Status: Completed
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: April 2024
• Source: New Ismailia National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 29, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Physical Disability

Intervention

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)

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

Locations

Country	Name	City	State
Egypt	College of Medicine	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
New Ismailia National University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change the respiratory functions	By increasing tidal volume	2 weeks
Primary	change the respiratory mechanics	increasing inspiratory capacity	2 weeks
Primary	change the bronchospasm	modifying mean airway pressure	2 weeks
Primary	change the amount of ventilation	increasing the oxygen saturation	2 weeks
Secondary	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
Secondary	weaning from mechanical ventilator	by improving previously mentioned respiratory function	from 2 to 4 weeks

External Links

•   open access article from national library of medicine