EvaluableStrapVentNCT05876468
Effects of Continuous Anterior Chest Compression
A study testing Continuous anterior chest compression in people with Evaluable, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluable
- What is being tested?
- Continuous anterior chest compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2022to 25 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 ans
- Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio <= 200 mmHg)
- The patent must be sedated and paralyzed
- Informed consent from patient or family members
Who cannot join
- Extracorporeal membrane oxygenation (ECMO)
- Pneumothorax
- Thoracic trauma during the last 3 months
- Refractory shock
- Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
- Pregnancy
Show all 9Show fewer
- Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
- No social care
- Adults under Guardianship, curatorship or protection of the court
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
About this study
Official title: " Effects of Continuous Anterior Chest Compression (CACC) & Comparision With Prone Position in ARDS Patients " The StrapVent Study "
The aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ARDS.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is usually characterized by inhomogeneous lesions, leading to an inhomogeneous distribution of the mechanical ventilation with the following several deleterious effects: atelectrauma of dependent posterior areas and overdistension in the anterior ones. Therefore, the gold standard treatment is to prevent VILI with lung protective ventilation : low tidal volume, high positive end expiratory pressure and prone positioning which is a technique that reduces mortality. Prone positioning has several beneficial effects : it relieves cardiac compression of the supporting lung, it stiffens the anterior chest wall thus limiting the risk of overdistension of anterior areas and promotes recruitment of non-dependent posterior pulmonary units. The overall effect is a more uniform distribution of transpulmonary pressures and improved ventilation to perfusion ratios.
Similar to prone positioning, continuous anterior chest wall compression stiffens the anterior chest wall. The investigators hypothesize that such reduction in anterior chest wall compliance may protect against overdistension and promote the redistribution of the ventilation in posterior areas.
- Conditions
- Evaluable
- Being tested
- Continuous anterior chest compression
- Keywords
- ARDS : Acute Respiratory Distress Syndrome, CACC : Continuous Anterior Chest Compression, VILI : Ventilator-Induced Lung Injury, ARDS,Human: Adult Respiratory Distress Syndrome
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous anterior chest compressionDevice
Patients with severe to moderate ARDS who were placed in prone position by the attending physician :
- First CACC : the applied pressure is equal to the one observed in the prone position
- Second CACC : The applied pressure is set at 60 - 80 cmH20
| Study group | Role | What they receive |
|---|---|---|
| A description of each arm of the clinical trial that indicates its role in the clinical trial | Experimental | Arm 1 Description:
The study will consitent of recording the measurments of ventilatory settings, respiratory mechanics, flow and pressure curves, gaz exchange, haemodynamics and ventilation distribution in 5 consecutive conditions in adult patients with moderate to severe ARDS :
* After 16 hours of prone position
* In supine position 1 hour after the prone position
* 15mn after CACC with a pressure equal to the one observed in the prone position
* 15mn after CACC with a pressure set at 60 - 80 cmH20
* 15mn after taking of the CACC Receives: Device: Continuous anterior chest compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
The end inspiratory transpulmonary pressure (PL-insp) in centimetre of water
The transpulmonary pressure will be measured by using an esophageal catheter connected to a differential pressure transducer. The PL-insp will be calculated using the ratio between the elastance of the lung (El) and of the respiratory system (Ers) expressed in centimetre of water thanks to this formula PL-insp = Plateau pressure x (El/Ers). The PL-insp between the different protocol conditions will be compared (After 16 hours of prone position, in supine position, 15mn after CACC with a pressure equal to the one observed in the prone position, 15mn after CACC with a pressure set at 60 - 80 cmH20, 15mn after taking off the CACC in supine position ). CACC will be considered protective if there is a decrease in Pl-insp.
Measured: Through study completion (up to 6 hours)
Secondary outcomes (8)
Regional pulmonary compliances in centimetre of water
Evaluation and comparison of pulmonary compliances in the different regions of interest (ROI) measured by Electrical Impedance Tomography (EIT) in the different protocol conditions.
Measured: Through study completion (up to 6 hours)
Lung mechanics : Airways pressure, Flow curves and Esophageal pressure
Airways pressure (Paw) will be measured in cmH2O and recorded by the mean of a differential pressure transducer.
Flow curves will be measured in L/mn and recorded by the mean of a pneumotachograph connected to the ventilator circuit.
Esophageal pressure (Pes) will be measured in cmH2O and recorded thanks to an esophageal balloon catheter introduced in the mid-esophagus of the patient and connected to differential pressure transducer.
Evaluation and comparison of respiratory mechanics in the different protocol conditions.
Measured: Through study completion (up to 6 hours)
Pulmonary ventilation distribution in percentage
Evaluation and comparison of the distribution of ventilation in the different regions of interest (ROI) measured by Electrical Impedance Tomography (EIT) in the different protocol conditions
Measured: Through study completion (up to 6 hours)
Recruitment-to-inflation (R/I) ratio
Evaluation and comparaison of R/I in the different protocol conditions
Measured: Through study completion (up to 6 hours)
Hemodynamics
Heart rate will be expressed in beats per minute, arterial blood pressure will be expressed in millimetre of mercury and norepinephrine perfusion will be expressed in milligrams per hour.
Measured: Through study completion (up to 6 hours)
Arterial blood gazes (ABG
pH, PaCO2 and PaO2 will be measured by standard clinical technique using the ICU blood gaz analyzer. PaCO2 and PaO2 will be expressed in millimetre of mercury.
Measured: Through study completion (up to 6 hours)
Incidence of CACC adverse events
CACC will be interrupted if :
- Reduction in oxygen saturation (SpO2) beneath 88% despite FiO2 optimisation.
- Reduction in mean arterial pressure beneath 60 mmHg
- Increase in norepinephrine perfusion beyond 0.5 mg/h
Measured: Through study completion (up to 6 hours)
End expiratory lung impedance (EELZ) expressed in arbitrary units
Evaluation and comparison of EELZ using EIT in the different protocol conditions.
Measured: Through study completion (up to 6 hours) ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start13 Apr 2022
- Primary completion25 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EvaluableStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trials with a single arm
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume CARTEAUX, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876468
- Sponsor's protocol ID
- APHP211357
- Acronym
- StrapVent
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Effects of Continuous Anterior Chest Compression (CACC) & Comparision With Prone Position in ARDS Patients " The StrapVent Study "
- ClinicalTrials.gov ID
- NCT05876468
- Acronym / sponsor ID
- StrapVent / APHP211357
- Conditions
- Evaluable
- Keywords
- ARDS : Acute Respiratory Distress Syndrome, CACC : Continuous Anterior Chest Compression, VILI : Ventilator-Induced Lung Injury, ARDS,Human: Adult Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 25 May 2023 (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.
The aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ARDS.
Detailed description
Acute respiratory distress syndrome (ARDS) is usually characterized by inhomogeneous lesions, leading to an inhomogeneous distribution of the mechanical ventilation with the following several deleterious effects: atelectrauma of dependent posterior areas and overdistension in the anterior ones. Therefore, the gold standard treatment is to prevent VILI with lung protective ventilation : low tidal volume, high positive end expiratory pressure and prone positioning which is a technique that reduces mortality. Prone positioning has several beneficial effects : it relieves cardiac compression of the supporting lung, it stiffens the anterior chest wall thus limiting the risk of overdistension of anterior areas and promotes recruitment of non-dependent posterior pulmonary units. The overall effect is a more uniform distribution of transpulmonary pressures and improved ventilation to perfusion ratios.
Similar to prone positioning, continuous anterior chest wall compression stiffens the anterior chest wall. The investigators hypothesize that such reduction in anterior chest wall compliance may protect against overdistension and promote the redistribution of the ventilation in posterior areas.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trials with a single arm
| Arm | Type | Receives |
|---|---|---|
| A description of each arm of the clinical trial that indicates its role in the clinical trial | Experimental | Device: Continuous anterior chest compressionArm 1 Description: The study will consitent of recording the measurments of ventilatory settings, respiratory mechanics, flow and pressure curves, gaz exchange, haemodynamics and ventilation distribution in 5 consecutive conditions in adult patients with moderate to severe ARDS : * After 16 hours of prone position * In supine position 1 hour after the prone position * 15mn after CACC with a pressure equal to the one observed in the prone position * 15mn after CACC with a pressure set at 60 - 80 cmH20 * 15mn after taking of the CACC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 ans
- Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio <= 200 mmHg)
- The patent must be sedated and paralyzed
- Informed consent from patient or family members
Key exclusion criteria (9 listed)
- Extracorporeal membrane oxygenation (ECMO)
- Pneumothorax
- Thoracic trauma during the last 3 months
- Refractory shock
- Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
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 |
|---|---|---|
| Continuous anterior chest compressionPatients with severe to moderate ARDS who were placed in prone position by the attending physician : * First CACC : the applied pressure is equal to the one observed in the prone position * Second CACC : The applied pressure is set at 60 - 80 cmH20 | Device | A description of each arm of the clinical trial that indicates its role in the clinical trial |
Primary outcome
The end inspiratory transpulmonary pressure (PL-insp) in centimetre of water
Time frame: Through study completion (up to 6 hours)
The transpulmonary pressure will be measured by using an esophageal catheter connected to a differential pressure transducer. The PL-insp will be calculated using the ratio between the elastance of the lung (El) and of the respiratory system (Ers) expressed in centimetre of water thanks to this formula PL-insp = Plateau pressure x (El/Ers). The PL-insp between the different protocol conditions will be compared (After 16 hours of prone position, in supine position, 15mn after CACC with a pressure equal to the one observed in the prone position, 15mn after CACC with a pressure set at 60 - 80 cmH20, 15mn after taking off the CACC in supine position ). CACC will be considered protective if there is a decrease in Pl-insp.
8 secondary outcomes
Regional pulmonary compliances in centimetre of water
Time frame: Through study completion (up to 6 hours)
Lung mechanics : Airways pressure, Flow curves and Esophageal pressure
Time frame: Through study completion (up to 6 hours)
Pulmonary ventilation distribution in percentage
Time frame: Through study completion (up to 6 hours)
Recruitment-to-inflation (R/I) ratio
Time frame: Through study completion (up to 6 hours)
Hemodynamics
Time frame: Through study completion (up to 6 hours)
Arterial blood gazes (ABG
Time frame: Through study completion (up to 6 hours)
Incidence of CACC adverse events
Time frame: Through study completion (up to 6 hours)
End expiratory lung impedance (EELZ) expressed in arbitrary units
Time frame: Through study completion (up to 6 hours) ]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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. This study is not recruiting at the moment.
Guillaume CARTEAUX, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous anterior chest compression in people with Evaluable, 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 9 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: finished, as of the sponsor's last update on 11 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The end inspiratory transpulmonary pressure (PL-insp) in centimetre of water (time frame: Through study completion (up to 6 hours)). 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 11 Feb 2026.