Effects of Ventilator Hyperinflation Versus Vibrocompression in Mechanically Ventilated Patients

NCT06791798 | Recruiting

• 1 other identifier: P.T.REC/012/005560
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanically Ventilated Patients; Lung Compliance; Airway Clearance Impairment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Oxygen Saturation (SPO2)

  Before, after treatment at Day 1 and Day 4

Study Arms (3)

Study Group (A)

ACTIVE COMPARATOR

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; Other: Traditional Chest Physical Therapy Program

Study Group (B)

ACTIVE COMPARATOR

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: Vibrocompression; Other: Traditional Chest Physical Therapy Program

Control Group (C)

ACTIVE COMPARATOR

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

Interventions

Ventilator Hyperinflation 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.

Study Group (A)

Vibrocompression 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.

Study Group (B)

Traditional Chest Physical Therapy Program OTHER

Percussion, Postural Drainage, and Suction

Control Group (C); Study Group (A); Study Group (B)

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr AL Ainy

Cairo, Egypt

RECRUITING

Study Officials

• Nadia H Mohamed, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia H Mohamed, MSc

CONTACT

+201148709641/+201220058803; nadia93hassan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, MSc in Physical Therapy, Cairo University

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)