Effects of Ventilator Hyperinflation Versus Vibrocompression in Mechanically Ventilated Patients

Effects of Ventilator Hyperinflation Versus Vibrocompression on Lung Compliance in Mechanically Ventilated Patients

The aim of the current study is to compare the effects of ventilator hyperinflation and vibrocompression on lung compliance in mechanically ventilated patients.

Study Overview

• Status: Recruiting
• Conditions: Mechanically Ventilated Patients; Airway Clearance Impairment; Lung Compliance
• Intervention / Treatment: Other: Ventilator Hyperinflation; Other: Traditional Chest Physical Therapy Program; Other: Vibrocompression

Detailed Description

Lower respiratory infections remained the world's most deadly communicable disease, ranked as the 4th leading cause of death.

The aim of mechanical ventilation is to reduce the ventilatory work and maintain gas exchange, but it also has deleterious effects on mucociliary transport and coughing ability. These effects provoke the stasis of secretions in the airways and bronchial obstruction, with hypoventilation, atelectasis, and consequent hypoxemia. This set of factors also favors microorganism multiplication and, thus, an increased incidence of ventilator-associated pneumonia (VAP), impaired gas exchange, pulmonary infection and fibrosis, and progressive reduction of lung compliance. To reverse or reduce these deleterious effects, bronchial hygiene techniques are used by physical therapists in several ICUs around the world. Among these techniques, tracheal aspiration, vibrocompression (VB), and hyperinflation with mechanical ventilation are commonly employed.

Lung compliance is inversely proportional to elastance. This elastic resistance is due to the elastic property of lung tissue or parenchyma and the surface elastic force. Any changes occurring to these forces could lead to changes in compliance. Compliance determines 65% of the work of breathing. If the lung has low compliance, it requires more work from breathing muscles to inflate the lungs. In specific pathologies, continuous monitoring of the lung compliance curve is useful to understand the condition's progression and to decide on therapeutic settings needed for ventilator management So, the current study will help to determine the effects of ventilator hyperinflation and vibrocompression on lung compliance and sputum production in mechanically ventilated patients.

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia H Mohamed, MSc; Phone Number: +201148709641/+201220058803; Email: nadia93hassan@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Kasr AL Ainy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Eighty-one mechanically ventilated patients more than 48 hours up to 7 days
• Their ages range from 35 to 55 years old.
• Medical stability (mean arterial pressure > 60 < 110, systolic blood pressure > 80, diastolic blood pressure > 60, fraction of inspired oxygen < 60, positive end expiratory pressure (PEEP) <10)

Exclusion Criteria:

Patients will be excluded if they have the following conditions or diseases:

• Unstable hemodynamics
• Fraction of inspired oxygen (FiO2) ≥ 0.6
• PEEP ≥ 10 cmH2O
• undrained pneumothorax and hemothorax or subcutaneous emphysema
• Pulmonary pathology (e.g., acute respiratory distress syndrome, exacerbation of chronic obstructive pulmonary disease, and acute pulmonary edema)
• Unstable neurological problems (raised intracranial pressure).
• Lung Cancer
• Recent/unhealed rib fracture
• Any disease obstructs our study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group (A); The patients in the study group (A) will be treated with ventilator hyperinflation in addition to a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day.	Other: Ventilator Hyperinflation; In ventilator hyperinflation volume control mode, the ventilator will be set to eight breaths per minute, and the tidal volume will be increased to deliver hyperinflation breaths that are 15 ml/kg, as will be calculated using the predicted body weight. Tidal volume will be increased in 150-ml increments until a peak airway pressure of 40 cmH2O is achieved. Once this pressure is reached, eight mechanical breaths will be delivered to the patient. After this, the ventilator will be reset to pretreatment variables, and the patient will be rested for 30 s. The sequence will be repeated. The treatment will consist of five sets of eight ventilator hyperinflation breaths.; Other: Traditional Chest Physical Therapy Program; Percussion, Postural Drainage, and Suction
Active Comparator: Study Group (B); The patients in the study group (B) will be treated with vibrocompression in addition to a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day.	Other: Traditional Chest Physical Therapy Program; Percussion, Postural Drainage, and Suction; Other: Vibrocompression; Vibrocompression will be performed by the physical therapist to produce vibration and will be combined with compression of the patient's chest in the expiratory phase. Every vibrocompression will be interrupted at the end of each expiratory phase to allow free inspiration.
Active Comparator: Control Group (C); The patients in the control group (C) will be treated with a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day.	Other: Traditional Chest Physical Therapy Program; Percussion, Postural Drainage, and Suction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Compliance	Static compliance (ml/cmH2O).	Before, after treatment at Day 1 and Day 4
Airway Resistance	Airway Resistance (cmH2O/l/s).	Before, after treatment at Day 1 and Day 4
Sputum Volume in ml	Airway suction will be carried out immediately after treatment or during treatment if indicated and will be measured as sputum volume in ml.	Immediately after treatment at Day 1 and Day 4
Peak Expiratory Flow and Peak Inspiratory Flow	Peak Expiratory Flow (l/min) and Peak Inspiratory Flow (l/min)	Before, after treatment at Day 1 and Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation (SPO2)	Peripheral oxygen saturation (SPO2) in percentage	Before, after treatment at Day 1 and Day 4

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Nadia H Mohamed, MSc, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: P.T.REC/012/005560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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