Alveolar Recruitment Manoeuverhemorecrut-2NCT04802421
Effect Alveolar Recruitment Manoeuver on Stroke Volume a Randomized Study
A study testing alveolar recruitment manoeuver in people with Alveolar Recruitment Manoeuver and Anesthesia, run by University Hospital, Caen at 1 site in France.
Trial summary
Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Recruitment Manoeuver, Anesthesia
- What is being tested?
- alveolar recruitment manoeuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2021to 1 Apr 2022
- 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
- adult patients scheduled for major surgery requiring hemodynamic monitoring
- written signed informed consent
Who cannot join
- pregnancy
- non sinusal heart rate
- known cardiac right ventricular failure or arterial pulmonary hypertension
- pneumothorax
- known pulmonary emphysema
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Caen
Caen, 14000
Jean-Luc Hanouz, M.D.,Ph.D., +33 2 31 06 47 36, hanouz-jl@chu-caen.fr
Cathy Gaillard, +33 2 31 06 53 49, gaillard-c@chu-caen.fr
About this study
Official title: Hemodynamic Effect of Alveolar Recruitment Manoeuver Through Stepwise Increase and Decrease in Irway Pressure or Sustained 30 Secondes 30 cmH2O Continuous Positive Airway Pressure. A Randomized Study.
Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery.
Read the detailed description
Following anesthesia and preload optimisation guided by cardiac stroke volume, patients will be randomised to one alveolr recruitment manoeuver :
- stepwise increase and decrease in positive airway pressure
- sustained 30 secondes 30 cmH2O continuous positive airway pressure The primary objective is the change in cardiac stroke volume.
- Conditions
- Alveolar Recruitment Manoeuver, Anesthesia
- Being tested
- alveolar recruitment manoeuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar recruitment manoeuverProcedure or surgery
alveolar recruitment manoeuver are recommended during general anesthesia to prevent pulmonary atelectasis
| Study group | Role | What they receive |
|---|---|---|
| CPAP30 | Active comparator | a 30 secondes 30 cmH2O continuous positive airway pressure applied after the orotracheal intubation will be checked and secured following induction of general anesthesia Receives: Procedure: alveolar recruitment manoeuver |
| STEP30 | Active comparator | a stepwise increase (+5 cmH2O) in postivie airway pressure from +5 cmH2O to +30 cmH2O and decrease (-5 cmH2O) from +30 cmH2O to +5 cmH2O applied after the orotracheal intubation will be checked and secured following induction of general anesthesia Receives: Procedure: alveolar recruitment manoeuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac stroke volume
change in cardiac stroke volume during the alveolar recruitment manoeuver
Measured: 1 min
Secondary outcomes (2)
arterial pressure
change in arterial pressure during the alveolar recruitment manoeuver
Measured: 1 min
recovery at 3 min
recovery of cardiacstroke volume and arterial pressure 3 min after the end of alveolar recruitment manoeuver
Measured: 3 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start12 Mar 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Recruitment ManoeuverStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- randomised parallel groups. randomisation between 2 groups equilibated by randomised blocks of 4, 6 or 8
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802421
- Sponsor's protocol ID
- CHU Caen Normandie 19-024
- Acronym
- hemorecrut-2
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dupont K, Lefrancois V, Delahaye A, Sanz M, Hestin R, Doublet T, Parienti JJ, Hanouz JL. Change in stroke volume during alveolar recruitment maneuvers through transient continuous positive airway pressure or stepwise increase in positive end expiratory pressure in anesthetized patients: a prospective randomized double-blind study. Can J Anaesth. 2024 Feb;71(2):224-233. doi: 10.1007/s12630-023-02644-7. Epub 2023 Nov 28.
PubMed 38017197
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effect of Alveolar Recruitment Manoeuver Through Stepwise Increase and Decrease in Irway Pressure or Sustained 30 Secondes 30 cmH2O Continuous Positive Airway Pressure. A Randomized Study.
- ClinicalTrials.gov ID
- NCT04802421
- Acronym / sponsor ID
- hemorecrut-2 / CHU Caen Normandie 19-024
- Conditions
- Alveolar Recruitment Manoeuver, Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 17 Mar 2021 (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.
Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery.
Detailed description
Following anesthesia and preload optimisation guided by cardiac stroke volume, patients will be randomised to one alveolr recruitment manoeuver :
- stepwise increase and decrease in positive airway pressure
- sustained 30 secondes 30 cmH2O continuous positive airway pressure The primary objective is the change in cardiac stroke volume.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- randomised parallel groups. randomisation between 2 groups equilibated by randomised blocks of 4, 6 or 8
| Arm | Type | Receives |
|---|---|---|
| CPAP30 | Active comparator | Procedure: alveolar recruitment manoeuvera 30 secondes 30 cmH2O continuous positive airway pressure applied after the orotracheal intubation will be checked and secured following induction of general anesthesia |
| STEP30 | Active comparator | Procedure: alveolar recruitment manoeuvera stepwise increase (+5 cmH2O) in postivie airway pressure from +5 cmH2O to +30 cmH2O and decrease (-5 cmH2O) from +30 cmH2O to +5 cmH2O applied after the orotracheal intubation will be checked and secured following induction of general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients scheduled for major surgery requiring hemodynamic monitoring
- written signed informed consent
Key exclusion criteria (5 listed)
- pregnancy
- non sinusal heart rate
- known cardiac right ventricular failure or arterial pulmonary hypertension
- pneumothorax
- known pulmonary emphysema
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 |
|---|---|---|
| alveolar recruitment manoeuveralveolar recruitment manoeuver are recommended during general anesthesia to prevent pulmonary atelectasis | Procedure or surgery | CPAP30, STEP30 |
Primary outcome
cardiac stroke volume
Time frame: 1 min
change in cardiac stroke volume during the alveolar recruitment manoeuver
2 secondary outcomes
arterial pressure
Time frame: 1 min
recovery at 3 min
Time frame: 3 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 38017197Dupont K, Lefrancois V, Delahaye A, Sanz M, Hestin R, Doublet T, Parienti JJ, Hanouz JL. Change in stroke volume during alveolar recruitment maneuvers through transient continuous positive airway pressure or stepwise increase in positive end expiratory pressure in anesthetized patients: a prospective randomized double-blind study. Can J Anaesth. 2024 Feb;71(2):224-233. doi: 10.1007/s12630-023-02644-7. Epub 2023 Nov 28.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alveolar recruitment manoeuver in people with Alveolar Recruitment Manoeuver and Anesthesia, run by University Hospital, Caen 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac stroke volume (time frame: 1 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04802421, which also lists 1 linked publication.
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 17 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.