HypoxemiaPROVECSNCT02866578
Open Lung Protective Ventilation in Cardiac Surgery
A study testing Open lung protective ventilation strategy in people with Hypoxemia, run by Assistance Publique Hopitaux De Marseille at 6 sites in France.
Trial summary
Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Open lung protective ventilation strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 6 sitesFrance
- Study dates
- 23 Sep 2016to 7 May 2018
- 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
- Cardiac surgery planned with CPB and sternotomy.
- Age > 18 years old.
Who cannot join
- Urgent surgery : cardiac transplantation, aortic dissection, active endocarditis.
- Aortic arch surgery with circulatory arrest.
- LVAD surgery.
- Acute or chronic preoperative hypoxemia (PaO2 < 65 mmHg in air).
- Preoperative shock state requiring catecholamines.
- LVEF < 40%.
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- Pulmonary hypertension with systolic pulmonary artery pressure > 50 mmHg.
- Severe right ventricular dysfunction (TDI tricuspid annular systolic velocity < 10 cm.s-1).
- Chronic kidney disease (Glomerular filtration rate < 30 mL/min).
- Body Mass Index > 35kg/m2.
- Patient's refusal.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Bordeaux
Bordeaux
Hôpital Louis Pradel HCL
Lyon
Assistance Publique Hopitaux de Marseille
Marseille, 13354
CHU MontpellierHôpital Arnaud de VILLENEUVE
Montpellier
Hôpital Européen Georges Pompidou AP-HP
Paris
CHU Strasbourg
Strasbourg
About this study
Official title: Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass : a Randomized Controlled Trial
Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary atelectasis seems to play a central role in the occurence of these PPCs. The open lung approach is a ventilation strategy that aims to "open the lung and keep it open" using different ventilatory settings. The efficacy of that strategy is not demonstrated in the global surgical population. However, its application in the perioperative care of cardiac surgery patients could be of great interest by counteracting the development of atelectasis.
The purpose of this multicentre, double blinded, randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the "open lung approach" on postoperative outcomes during the first 7 days following cardiac surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB. It will be compared to a conventional approach without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary endpoint is any post-operative pulmonary complication. The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7.
- Conditions
- Hypoxemia
- Being tested
- Open lung protective ventilation strategy
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open lung protective ventilation strategyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Open lung protective ventilation | Experimental | * Recruitment maneuvers (30 cmH2O during 30 seconds) after intubation, after CPB initiation, before aortic declamping and at ICU arrival.
* PEEP at 8 cmH2O.
* Ultraprotective ventilation during CPB: PEEP 8 cmH2O, Tidal volume 3mL/kg, Respiratory rate 12 cycles per minute, FiO2 40%.
* Assigned intervention - Procedure: patients are randomized and ventilated with the open lung strategy from intubation to detubation. Receives: Procedure: Open lung protective ventilation strategy |
| Conventional strategy | No intervention | No recruitment maneuvers. PEEP at 2 cmH2O. During CPB: continuous positive pressure at 2 cmH2O. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pulmonary complications defined as a composite endpoint
Mild hypoxemia Moderate hypoxemia Severe hypoxemia Severe bronchospam Radiological atelectasis Respiratory acidosis Pneumonia Pleural effusion Acute Respiratory Distress Syndrome Need for reintubation Need for reintubation
Measured: first 7 days post-operatively.
Secondary outcomes (2)
Postoperative extrapulmonary complication
Systemic inflammatory response syndrome Sepsis Septic chock Mediastinitis Pericardial tamponade Surgical bleeding Acute kidney failure (KDIGO stage 2 or 3) Postoperative atrial fibrillation Cardiogenic chock Delirium
Measured: First 7 days post operatively
ICU free Days
Days alive and free from the need of intensive care
Measured: First 7 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start23 Sep 2016
- Primary completion7 May 2018
- Study completion7 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866578
- Sponsor's protocol ID
- 2016-03
- Other IDs
- 2016-A00352-49
- Acronym
- PROVECS
- Status last verified
- Dec 2016
- First submitted
- 7 Jul 2016
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.
PubMed 31576435Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y.
PubMed 30424770
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02866578
- Acronym / sponsor ID
- PROVECS / 2016-03
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 15 Aug 2016 (estimated)
- 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.
Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary atelectasis seems to play a central role in the occurence of these PPCs. The open lung approach is a ventilation strategy that aims to "open the lung and keep it open" using different ventilatory settings. The efficacy of that strategy is not demonstrated in the global surgical population. However, its application in the perioperative care of cardiac surgery patients could be of great interest by counteracting the development of atelectasis.
The purpose of this multicentre, double blinded, randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the "open lung approach" on postoperative outcomes during the first 7 days following cardiac surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB. It will be compared to a conventional approach without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary endpoint is any post-operative pulmonary complication. The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open lung protective ventilation | Experimental | Procedure: Open lung protective ventilation strategy* Recruitment maneuvers (30 cmH2O during 30 seconds) after intubation, after CPB initiation, before aortic declamping and at ICU arrival. * PEEP at 8 cmH2O. * Ultraprotective ventilation during CPB: PEEP 8 cmH2O, Tidal volume 3mL/kg, Respiratory rate 12 cycles per minute, FiO2 40%. * Assigned intervention - Procedure: patients are randomized and ventilated with the open lung strategy from intubation to detubation. |
| Conventional strategy | No intervention | –No recruitment maneuvers. PEEP at 2 cmH2O. During CPB: continuous positive pressure at 2 cmH2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cardiac surgery planned with CPB and sternotomy.
- Age > 18 years old.
Key exclusion criteria (11 listed)
- Urgent surgery : cardiac transplantation, aortic dissection, active endocarditis.
- Aortic arch surgery with circulatory arrest.
- LVAD surgery.
- Acute or chronic preoperative hypoxemia (PaO2 < 65 mmHg in air).
- Preoperative shock state requiring catecholamines.
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 |
|---|---|---|
| Open lung protective ventilation strategy | Procedure or surgery | Open lung protective ventilation |
Primary outcome
Post-operative pulmonary complications defined as a composite endpoint
Time frame: first 7 days post-operatively.
Mild hypoxemia Moderate hypoxemia Severe hypoxemia Severe bronchospam Radiological atelectasis Respiratory acidosis Pneumonia Pleural effusion Acute Respiratory Distress Syndrome Need for reintubation Need for reintubation
2 secondary outcomes
Postoperative extrapulmonary complication
Time frame: First 7 days post operatively
ICU free Days
Time frame: First 7 days post operatively
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 20 Mar 2023.
- Derived from this study: PubMed 31576435Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.
- Derived from this study: PubMed 30424770Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Urielle DESALBRES study director
AP-HM
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open lung protective ventilation strategy in people with Hypoxemia, run by Assistance Publique Hopitaux De Marseille at 6 sites 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 11 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 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Post-operative pulmonary complications defined as a composite endpoint (time frame: first 7 days post-operatively.). 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 NCT02866578, which also lists 2 linked publications.
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 20 Mar 2023.