Clinical trial NCT06805357: Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients
Official title: Evaluation of Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intensive Care
Invasive Mechanical Ventilation
Chest Physiotherapy
Airway Clearance
Keywords: ICU
Lung recruitment
Respiratory physiotherapy
Rib Cage Compressions (RCC)
mechanical ventilation
intensive care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The cross-over concerns the ventilatory mode during chest physiotherapy
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of ΔEELV (after-before) Induced by an RCC Session Performed in V-ACV and PSV
timeFrame: EELV is mesured 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session (morning & afternoon).
measure: Variation in FiO2 During the Session
timeFrame: FiO2 variation is during the physiotherapy session and up to 5 minutes after the session.
Secondary outcomes:
measure: Measurement of Airflow in the Ventilator Circuit During Respiratory Physiotherapy Sessions
timeFrame: during and up to 5 minutes after each physiotherapy session
measure: mucus volume measurement
timeFrame: measured after each physiotherapy session.
measure: Assessment of gas exchange.
timeFrame: 5 minutes before and 5 minutes after each physiotherapy session
measure: Assessment of regional lung ventilation distribution.
timeFrame: 5 minutes before, during and 5 minutes after each physiotherapy session.
measure: Heart rate
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
measure: Assessment of Airway Pressure Dynamics in the Ventilator Circuit During Respiratory Physiotherapy
timeFrame: during and up to 5 minutes after each physiotherapy session
measure: Quantification of mucus weight
timeFrame: measured after each physiotherapy session.
measure: Respiratory rate
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
measure: oxygen saturation measurement
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
measure: Blood pressure
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
measure: end-tidal CO2 measurement
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
measure: Tidal volume
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
measure: minute volume
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
measure: peak inspiratory pressure
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
measure: plateau pressure
timeFrame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Intensive Care Medicine Department Henri Mondor Hospital
Study officials:
References: