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Recruiting NCT06805357

Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients

No phase Interventional Intensive Care Invasive Mechanical Ventilation Chest Physiotherapy Airway Clearance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chest Physiotherapy by Rib Cage Compressions (RCC).
Who it may be relevant to
Registry conditions: Intensive Care, Invasive Mechanical Ventilation, Chest Physiotherapy, Airway Clearance. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Comparison of ΔEELV (after-before) Induced by an RCC Session Performed in V-ACV and PSV [Time frame: EELV is mesured 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session (morning & afternoon).]
  • Variation in FiO2 During the Session [Time frame: FiO2 variation is during the physiotherapy session and up to 5 minutes after the session.]
Secondary outcome measures (12)
  • Measurement of Airflow in the Ventilator Circuit During Respiratory Physiotherapy Sessions [Time frame: during and up to 5 minutes after each physiotherapy session]
  • mucus volume measurement [Time frame: measured after each physiotherapy session.]
  • Assessment of gas exchange. [Time frame: 5 minutes before and 5 minutes after each physiotherapy session]
  • Assessment of regional lung ventilation distribution. [Time frame: 5 minutes before, during and 5 minutes after each physiotherapy session.]
  • Heart rate [Time frame: 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 [Time frame: during and up to 5 minutes after each physiotherapy session]
  • Quantification of mucus weight [Time frame: measured after each physiotherapy session.]
  • Respiratory rate [Time frame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.]
  • oxygen saturation measurement [Time frame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.]
  • Blood pressure [Time frame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.]
  • end-tidal CO2 measurement [Time frame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.]
  • Tidal volume [Time frame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Intensive Care Medicine Department Henri Mondor Hospital — Créteil

Identifiers

NCT: NCT06805357 · APHP240157

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗