Intensive CareRECRUTKINCT06805357
Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients
A study testing Chest Physiotherapy by Rib Cage Compressions (RCC) in people with Intensive Care and Invasive Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intensive Care, Invasive Mechanical Ventilation, Chest Physiotherapy
- What is being tested?
- Chest Physiotherapy by Rib Cage Compressions (RCC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2024to 23 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Intensive Care Medicine Department Henri Mondor Hospital
Créteil, 94000
About this study
Official title: 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.
Read the 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.
- Being tested
- Chest Physiotherapy by Rib Cage Compressions (RCC)
- Keywords
- ICU, Lung recruitment, Respiratory physiotherapy, Rib Cage Compressions (RCC), mechanical ventilation, intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| RCC applied in V-ACV | Other | Doest't require description. Receives: Other: Chest Physiotherapy by Rib Cage Compressions (RCC) |
| RCC applied in PS | Other | Doest't require description. Receives: Other: Chest Physiotherapy by Rib Cage Compressions (RCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: 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: measured after each physiotherapy session.
Assessment of gas exchange.
Arterial blood gases are performed only if the patient has an arterial catheter
Measured: 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.
Measured: 5 minutes before, during and 5 minutes after each physiotherapy session.
Heart rate
quantified in beats per minute (bpm)
Measured: 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.
Measured: 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: measured after each physiotherapy session.
Respiratory rate
expressed in breaths per minute (bpm)
Measured: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
oxygen saturation measurement
measured as a percentage (%)
Measured: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
Blood pressure
Recorded in millimeters of mercury (mmHg)
Measured: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
end-tidal CO2 measurement
measured in millimeters of mercury (mmHg)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start23 Jul 2024
- Primary completion23 Jun 2027 (estimated)
- Study completion23 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The cross-over concerns the ventilatory mode during chest physiotherapy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805357
- Sponsor's protocol ID
- APHP240157
- Acronym
- RECRUTKI
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06805357
- Acronym / sponsor ID
- RECRUTKI / APHP240157
- Keywords
- ICU, Lung recruitment, Respiratory physiotherapy, Rib Cage Compressions (RCC), mechanical ventilation, intensive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 23 Jun 2027 (estimated)
- Study completion
- 23 Jun 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The cross-over concerns the ventilatory mode during chest physiotherapy
| Arm | Type | Receives |
|---|---|---|
| RCC applied in V-ACV | Other | Other: Chest Physiotherapy by Rib Cage Compressions (RCC)Doest't require description. |
| RCC applied in PS | Other | Other: Chest Physiotherapy by Rib Cage Compressions (RCC)Doest't require description. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, RCC applied in V-ACV |
Primary outcome
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).
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.
Variation in FiO2 During the Session
Time frame: FiO2 variation is during the physiotherapy session and up to 5 minutes after 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.
15 secondary outcomes
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.
minute volume
Time frame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
peak inspiratory pressure
Time frame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
plateau pressure
Time frame: 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Physiotherapy by Rib Cage Compressions (RCC) in people with Intensive Care and Invasive Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Pr CARTEAUX, MD,PhD (01 45 17 86 38, guillaume.carteaux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.