Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients

NCT06805357 | Recruiting

• 1 other identifier: APHP240157
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In intensive care, respiratory physiotherapy is an integral part of the daily care of patients under invasive mechanical ventilation. Its goals are to improve the clearance of bronchial secretions to allow for the resolution of atelectasis and alveolar recruitment, thereby enhancing respiratory mechanics and gas exchange. The most widespread technique in France is external expiratory compression of the chest. The effectiveness of this technique depends on the selection of patients (it seems to be more effective in patients with higher secretion levels) and on the practical implementation of the technique (favoring brief and vigorous compressions at the beginning of expiration). However, the effect of the artificial ventilator settings, particularly the ventilatory mode used during the respiratory physiotherapy session, has never been evaluated. The two most commonly used ventilatory modes worldwide are Volume Assist Control Ventilation (V-ACV) and pressure support ventilation (PSV). In this unit, respiratory physiotherapy under artificial ventilation is performed daily on patients with artificial ventilation with abundant secretions, regardless of the ventilatory mode.

Conditions

Intensive Care; Chest Physiotherapy; Airway Clearance; Invasive Mechanical Ventilation

Keywords

ICU; Lung recruitment; Respiratory physiotherapy; Rib Cage Compressions (RCC); mechanical ventilation; intensive care

Outcome Measures

Primary Outcomes (2)

• Comparison of ΔEELV (after-before) Induced by an RCC Session Performed in V-ACV and PSV

  the variation in end-expiratory lung volume (ΔEELV), which refers to the change in the volume of air in the lungs at the end of expiration. This is measured by comparing the end-expiratory lung volume 5 minutes before and 5 minutes after the respiratory physiotherapy session. The ΔEELV is measured in milliliters using the E-sCOVX module of the CARESCAPE R860 ventilator, which employs the nitrogen wash-in/wash-out technique.

  EELV is mesured 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session (morning & afternoon).

• Variation in FiO2 During the Session

  the variation in FiO2 (fraction of inspired oxygen) during the physiotherapy session. FiO2 refers to the percentage of oxygen delivered to the patient through the ventilator. This variation is tracked to assess any changes in the oxygen concentration during the session. The FiO2 variation is expressed as a percentage, with a typical variation of +10% during the procedure, measured using the CARESCAPE R860 ventilator.

  FiO2 variation is during the physiotherapy session and up to 5 minutes after the session.

Secondary Outcomes (15)

• Measurement of Airflow in the Ventilator Circuit During Respiratory Physiotherapy Sessions

  during and up to 5 minutes after each physiotherapy session

• mucus volume measurement

  measured after each physiotherapy session.

• Assessment of gas exchange.

  5 minutes before and 5 minutes after each physiotherapy session

• Assessment of regional lung ventilation distribution.

  5 minutes before, during and 5 minutes after each physiotherapy session.

• Heart rate

  5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.

Study Arms (2)

RCC applied in V-ACV

OTHER

Doest't require description.

Other: Chest Physiotherapy by Rib Cage Compressions (RCC)

RCC applied in PS

OTHER

Doest't require description.

Other: Chest Physiotherapy by Rib Cage Compressions (RCC)

Interventions

Chest Physiotherapy by Rib Cage Compressions (RCC) OTHER

Bimanual Rib Cage Compressions (RCC) applied to the thorax only, with patients in a standardized position (supine with the head of the bed elevated to 35 degrees). The intervention is standardized in terms of the direction of force (posterior and downward) and the characteristics of the compression (brief and vigorous compressions at the beginning of expiration).

RCC applied in PS; RCC applied in V-ACV

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient under assisted ventilation (in V-ACV or PSV) triggering all ventilator cycles
• Patient deemed " secretive ": requiring ≥ 2 tracheal aspirations every 3 hours
• Patient (or relative) who has given consent to participate in the research
• Patient covered by social security

You may not qualify if:

• Age under 18 years
• Legal guardian required
• Recent cardiac and/or thoracic and/or abdominal surgery (\< 3 months)
• Rib fracture(s)
• Pneumothorax and/or presence of a chest drain
• Recent neurosurgery (\< 3 months) and/or proven or suspected increased intracranial pressure (ICP)
• Hemodynamic instability defined as: noradrenaline ≥ 1mg/h, adrenaline ≥ 0.5 mg/h, dobutamine ≥ 5γ/kg/min.
• Respiratory instability defined as: PEEP \> 10 cmH2O and/or PaO2/FiO2 \< 150 mm Hg
• Pregnancy
• Hemoptysis
• Sever skin lesions (e.g., burns, Lyell's syndrome)
• Patient under foreign health insurance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Intensive Care Medicine Department Henri Mondor Hospital

Créteil, 94000, France

RECRUITING

Central Study Contacts

Guillaume Pr CARTEAUX, MD,PhD

CONTACT

01 45 17 86 38; guillaume.carteaux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The cross-over concerns the ventilatory mode during chest physiotherapy

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 3, 2025
• Study Start: July 23, 2024
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): June 23, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)