Effects of Ventilator Hyperinflation Versus Vibrocompression in Mechanically Ventilated Patients

NCT ID: NCT06791798

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-05-31

Brief Summary

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

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.

Conditions

Mechanically Ventilated Patients; Lung Compliance; Airway Clearance Impairment

Study Design

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

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ventilator Hyperinflation

Intervention Type: OTHER

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.

Traditional Chest Physical Therapy Program

Intervention Type: OTHER

Percussion, Postural Drainage, and Suction

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.

Group Type: ACTIVE_COMPARATOR

Vibrocompression

Intervention Type: OTHER

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.

Traditional Chest Physical Therapy Program

Intervention Type: OTHER

Percussion, Postural Drainage, and Suction

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.

Group Type: ACTIVE_COMPARATOR

Traditional Chest Physical Therapy Program

Intervention Type: OTHER

Percussion, Postural Drainage, and Suction

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Traditional Chest Physical Therapy Program

Percussion, Postural Drainage, and Suction

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nadia Hassan Mohamed Hussien

Physical Therapist, MSc in Physical Therapy, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadia H Mohamed, MSc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr AL Ainy

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nadia H Mohamed, MSc

Role: CONTACT

nadia93hassan@gmail.com

+201148709641/+201220058803

Other Identifiers

P.T.REC/012/005560

Identifier Type: -

Identifier Source: org_study_id