Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients (RECRUTKI)

Evaluation of Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care; Invasive Mechanical Ventilation; Chest Physiotherapy; Airway Clearance
• Intervention / Treatment: Other: Chest Physiotherapy by Rib Cage Compressions (RCC)

Detailed Description

It is hypothesized that the effectiveness of respiratory physiotherapy on recruitment depends on the ventilatory mode used during the session.

The primary objective is to compare pulmonary recruitment during respiratory physiotherapy in patients under invasive mechanical ventilation between sessions performed in V-ACV and PSV.

Secondary objectives are to compare the effects of respiratory physiotherapy between V-ACV mode and PSV mode on respiratory mechanics, gas exchange, the amount of drained secretions (weight and volume), the distribution of ventilation, and patient tolerance.

Method:

A cross-over study with a non-invasive physiological endpoint. The primary evaluation criterion is variations in end-expiratory lung volume (ΔEELV) measured 5 minutes before and 5 minutes after a standardized respiratory physiotherapy session in V-ACV or PSV.

The tool used to measure End Expiratory Lung Volume (EELV) is the additional module E-sCOVX of the CARESCAPE R860 ventilator. The procedure is automated and is based on a dilution method.

Secondary outcomes aim to evaluate regional lung ventilation distribution, respiratory mechanics, airway clearance, gas exchange, and patient tolerance.

Tools used to measure secondary evaluation criteria include Electrical Impedance Tomography (EIT) Pulmovista 500® (Dräger), a Pneumotachograph with a pressure transducer inserted in the ventilator circuit (MP150, Biopac Systems, Inc.), and a trap to collect mucus.

The intervention consists of a standardized session in a standardized position (supine at 35° of head elevation).

Each session is composed of 7 series of 3 Rib Cage Compressions (RCC) in a row during each expiration, applied to the thorax only. The interval between the series is about 10 respiratory cycles.

The 2 sessions are done on the same day. One session is performed in the morning, the other in the afternoon. One session is performed in V-ACV and the other in PSV. The order is randomized.

Conclusion:

The results of this study will help better understand the effects of RCC according to the ventilatory mode in patients under invasive mechanical ventilation with mucus excess.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Pr CARTEAUX, MD,PhD; Phone Number: 01 45 17 86 38; Email: guillaume.carteaux@aphp.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • Intensive Care Medicine Department Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: RCC applied in V-ACV; Doest't require description.	Other: Chest Physiotherapy by Rib Cage Compressions (RCC); 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).
Other: RCC applied in PS; Doest't require description.	Other: Chest Physiotherapy by Rib Cage Compressions (RCC); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Airflow in the Ventilator Circuit During Respiratory Physiotherapy Sessions	A pneumotachograph, which measures the flow of air entering and exiting the ventilator circuit, is used for this assessment. The airflow is recorded in liters per minute and provides insight into the volume of air being ventilated during the session. This data is collected using the MP150 Pneumotachograph	during and up to 5 minutes after each physiotherapy session
mucus volume measurement	A mucus collection trap (Cair, LGL) is positioned on the suction line, and the volume of the extracted mucus is precisely measured using a syringe. The volume is recorded in milliliters to assess the amount of mucus cleared during the respiratory physiotherapy session.	measured after each physiotherapy session.
Assessment of gas exchange.	Arterial blood gases are performed only if the patient has an arterial catheter	5 minutes before and 5 minutes after each physiotherapy session
Assessment of regional lung ventilation distribution.	Electrical Impedance Tomography (EIT) Pulmovista 500® (Dräger) with the dedicated belt.	5 minutes before, during and 5 minutes after each physiotherapy session.
Heart rate	quantified in beats per minute (bpm)	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
Assessment of Airway Pressure Dynamics in the Ventilator Circuit During Respiratory Physiotherapy	A pressure transducer is inserted into the ventilator circuit to measure the airway pressure within the system during the session. This pressure is typically measured in cmH2O. The pressure readings are also analyzed using Acknowledge 5.0 software to evaluate how the airway pressure changes throughout the physiotherapy session.	during and up to 5 minutes after each physiotherapy session
Quantification of mucus weight	the mucus is transferred to a high-precision scale to determine its weight, expressed in grams.	measured after each physiotherapy session.
Respiratory rate	expressed in breaths per minute (bpm)	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
oxygen saturation measurement	measured as a percentage (%)	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
Blood pressure	Recorded in millimeters of mercury (mmHg)	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
end-tidal CO2 measurement	measured in millimeters of mercury (mmHg)	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
Tidal volume	quantified in milliliters (mL), denoting the volume of air inspired or expired during a single respiratory cycle.	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
minute volume	expressed in liters per minute (L/min), representing the total volume of air ventilating the lungs in one minute.	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
peak inspiratory pressure	measured in centimeters of water (cmH2O), indicating the maximum pressure reached in the ventilator circuit during the inspiratory phase.	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
plateau pressure	uantified in centimeters of water (cmH2O), representing the pressure measured at the end of an inspiratory hold, when airflow has ceased.	5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): June 23, 2027

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mechanical ventilation; ICU; intensive care; Lung recruitment; Respiratory physiotherapy; Rib Cage Compressions (RCC)
• Other Study ID Numbers: APHP240157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No