Lung DiseasesI-PEEP-THONCT05525312
Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery.
A study testing "Open-lung" protective ventilation strategy and "Standard" protective ventilation strategy in people with Lung Diseases, run by University Hospital, Montpellier at 1 site in France.
Trial summary
During thoracic surgery, one-lung ventilation (OLV) is associated with hypoxemia, lung injury, and perioperative respiratory complications. The level of positive-end expiratory pressure (PEEP) to apply during OLV remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- "Open-lung" protective ventilation strategy and "Standard" protective ventilation strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2024to 20 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be over 18 years old,
- To be able to attend all scheduled visits and to comply with all trial procedures,
- To be scheduled for a lung cancer resection surgery (performed by either video-assisted thoracoscopy or thoracotomy).
Who cannot join
- Non-carcinologic indication of lung resection (e.g. Lung volume reduction for bullous emphysema reduction, lung abscess),
- Bilateral pulmonary resection surgery or history of lung resection surgery,
- Lung resection under sternotomy
- Non intubated video-assisted thoracoscopy
- Robotic thoracic surgery
- Contraindication to esophageal catheter (history of esophageal varices, hepatic cirrhosis child ≥ b, esophageal or gastric surgery, thoracic radiotherapy, latex allergy),
Show all 19Show fewer
- ASA (American Society of Anesthesiologists) score ≥ 4,
- Chronic obstructive pulmonary disease GOLD III or IV (Forced Expiratory Volume, FEV<50%),
- Uncontrolled asthma (FEV <50%),
- Intracardiac shunt,
- Hemoglobinopathy making the SpO2 values invalid,
- Heart failure NYHA III or IV,
- Documented pulmonary hypertension (Mean Pulmonary Arterial Pressure at rest, mPAP>20 mmHg),
- To be under legal protection,
- Unable to read or write,
- Lack of informed consent, or unable to give consent,
- Refusal to participate in the study,
- Pregnancy in progress or planned during the study period, pregnant or nursing women,
- Not being affiliated to a French social security system or being a beneficiary of such a system.
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
Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
Montpellier, 34090
Hélène DAVID, Doctor
About this study
Official title: Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery: "Open Lung" Approach With Individualized Level of Positive End-expiratory Pressure Titrated According to the Best Lung Compliance, Versus "Standard" Care: a Randomized Controlled Trial
During thoracic surgery, one-lung ventilation (OLV) is associated with hypoxemia, lung injury, and perioperative respiratory complications. The level of positive-end expiratory pressure (PEEP) to apply during OLV remains controversial. The open-lung approach consists in setting a level of PEEP corresponding to the best lung compliance, using an esophageal catheter to measure the transpulmonary pressure. This approach has been effective in laparoscopic surgeries or acute respiratory distress syndrome, but has never been evaluated in thoracic surgery.
Read the detailed description
Pulmonary resection surgery plays a key role in the treatment of localized lung cancer. During thoracic surgery, lung isolation is necessary. One-lung ventilation (OLV) is associated with frequent intraoperative respiratory complications, hypoxemia or lung injury related to mechanical ventilation. Intraoperative events increase the risk of postoperative complications resulting from either hypoxemia (atrial fibrillation, delirium, acute kidney injury) or lung injury (atelectasis, pulmonary edema, pneumonia, acute respiratory distress syndrome (ARDS)).
During OLV, a protective ventilation strategy is now recommended, including a low tidal volume (VT), using the lowest fraction of inspired oxygen (FiO2) due to the toxicity of high-oxygen concentration, and recruitment maneuvers (RM). But there is no consensus on the level of positive end-tidal pressure (PEEP) to apply. A low level of PEEP increases the risk of alveolar collapse, when a too high level leads to alveolar overdistension and increases lung dead space. The PEEP is usually arbitrary fixed to 5 cmH2O for every patient, which does not take into account the individual characteristics of the patient. Recent clinical trials in thoracic surgery showed that titration of PEEP according to the lowest airway driving pressure [end-inspiratory plateau pressure - total end-expiratory pressure], compared to a standard PEEP of 5 cmH2O, increased oxygenation and lung mechanics, and decreased significantly respiratory complications.
The transpulmonary pressure (PTP) is the instantaneous difference between alveolar pressure and pleural pressure. In order to optimize the alveolocapillary gas exchange, the level of PEEP should be titrated until achieving the best lung compliance (CL), defined by the ratio [(tidal volume) / (driving PTP = end-inspiratory PTP - end-expiratory PTP)]. As the tidal volume is set on the ventilator, the level of PEEP corresponding to the best CL is the one associated with the lowest driving PTP. The "open lung" strategy consists in setting the level of PEEP according to the best CL, which is an individualized approach, probably more physiologic than the standard care.
The esophageal pressure (PES) measured by an esophageal catheter is a validated estimation of the pleural pressure. Then, the PTP could be approximated by the difference [airway plateau pressure - PES]. The placement of an esophageal catheter is safe provided that the use respects contraindications (mainly esophageal disease or varices).
In ARDS, the open lung approach using an esophageal catheter was associated with a better clinical outcome than the standard non-individualized protocol. In laparoscopic surgery, the effects of PEEP on the PTP is also well described. In thoracic surgery, to date, monitoring PES and PTP is not part of the usual care. To our knowledge, only one study described the PTP changes during OLV. In this study, the best PEEP during OLV differed from one patient to another, which goes against the "one size fits all" theory. Thus, the PEEP should be titrated and individualized. Nevertheless, the airway driving pressure is only an approximation of the PTP, since it does not take into account the pleural pressure, which is a non-negligible extra-alveolar factor when talking about patients with lung or pleural diseases. Measuring the driving PTP using an esophageal catheter is certainly more accurate.
- Conditions
- Lung Diseases
- Being tested
- "Open-lung" protective ventilation strategy, "Standard" protective ventilation strategy
- Keywords
- Pulmonary resection surgery, One lung ventilation, Positive end-expiratory pressure, Esophageal pressure, Transpulmonary pressure, Lung compliance, Protective ventilation, Hypoxemia, Postoperative complications
- Medical subject headings
- Lung Diseases, Hypoxia, Postoperative Complications
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
In the "open-lung" group, the positive end-tidal pressure (PEEP) is titrated to match the best lung compliance. During a "PEEP decrement trial", PEEP is decreased from 20 cmH2O to 4 cmH2O by steps of 2 cmH2O/minute, and the driving the transpulmonary pressure (PTP) is calculated at each level of PEEP. In the "open-lung" group, the targeted PEEP corresponds to the lowest driving PTP during the "PEEP decrement trial", meaning the best lung compliance. Thereafter, the PEEP is set at this level and maintained until extubation.
"Standard" protective ventilation strategyProcedure or surgery
In the "standard" group, the positive end-tidal pressure (PEEP) is arbitrarily set at 5 cmH2O, since this is the currently recommended level of PEEP, commonly used in control groups of previous clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| "Standard" protective ventilation | Other | Patients receiving a positive-end expiratory pressure (PEEP) of 5 cmH2O Receives: Procedure: "Standard" protective ventilation strategy |
| "Open lung" protective ventilation protocol | Experimental | Patients with a titrated positive-end expiratory pressure (PEEP) corresponding to the best lung compliance calculated with transpulmonary pressure. Receives: Procedure: "Open-lung" protective ventilation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intraoperative hypoxemia
A SpO2<92% while the FiO2 is progressively decreased to 50% according to a standardized algorithm.
Measured: During the Open-Lung Ventilation (OLV) period
Secondary outcomes (17)
Hypoxemia events
The number of hypoxemia events, depth, and duration of hypoxemia.
Measured: During the OLV period
The ventilatory parameters
Plateau pressure (mbar)
Measured: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
The ventilatory parameters
Driving PTP (cmH2O)
Measured: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
The ventilatory parameters
Airway driving pressure (cmH2O)
Measured: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
The ventilatory parameters
Lung compliance (ml/cmH2O)
Measured: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Blood gas analysis
PaO2/FiO2 ratio (mmHg)
Measured: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Blood gas analysis
PaCO2 (mmHg)
Measured: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Blood gas analysis
pH
Measured: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Blood gas analysis
HCO3- (mmol/L)
Measured: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Intraoperative events related to hypoxemia
Additional recruitment maneuvers (cmH2O)
Measured: During the OLV period
Intraoperative events related to hypoxemia
Additional bronchoscopy
Measured: During the OLV period
Intraoperative events related to hypoxemia
Application of a selective PEEP to the operated lung using an auxiliary valve
Measured: During the OLV period
Intraoperative events related to hypoxemia
Re-expansion and ventilation of the operated lung performed for hypoxemia
Measured: During the OLV period
Intraoperative events not only due to hypoxemia
Atrial fibrillation (bpm), hypotension defined by systolic arterial pressure < 90 mmHg, needs for vasopressor,
Measured: During the OLV period
Postoperative respiratory complications until postoperative day 28
Acute respiratory distress syndrome (ARDS) (diagnosed according to the Berlin definition), atelectasis or pleural effusion (documented on a postoperative chest radiograph), pneumonia (postoperative fever combined with an evocating chest radiograph, requiring antibiotics, with or without microbiologic confirmation), need for prolonged oxygen therapy (> 48 hours), need for high-flow nasal oxygen therapy, needs for postoperative invasive or noninvasive mechanical ventilation
Measured: Day 28
Non-respiratory postoperative complications until postoperative day-28 (POD28)
Cardiovascular events such as myocardial infarction (troponin > threshold, combined with EKG modification or chest pain) or new-onset of atrial fibrillation (if the cardiac rhythm was sinus before surgery), acute kidney injury (defined by an AKIN stage ≥ 1), stroke (with CT scan or MRI confirmation) or transient ischemic attack, delirium (acutely disturbed state of mind)
Measured: Day 28
The hospital stay
The in-hospital length of stay and hospital free-days at POD28, the hospital re-admission, ICU admission, and mortality at POD28 and POD90.
Measured: Day 28 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start20 Mar 2024
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the "standard" protective ventilation versus an "open lung" protective ventilation protocol during a pulmonary resection surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525312
- Sponsor's protocol ID
- RECHMPL19_0492
- Acronym
- I-PEEP-THO
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2022
- Last updated
- 31 Mar 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies of One-lung Ventilation in Patients Undergoing Carcinological Lung Resection Surgery: "Open Lung" Approach With Individualized Level of Positive End-expiratory Pressure Titrated According to the Best Lung Compliance, Versus "Standard" Care: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05525312
- Acronym / sponsor ID
- I-PEEP-THO / RECHMPL19_0492
- Conditions
- Lung Diseases
- Keywords
- Pulmonary resection surgery, One lung ventilation, Positive end-expiratory pressure, Esophageal pressure, Transpulmonary pressure, Lung compliance, Protective ventilation, Hypoxemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 1 Sep 2022 (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.
During thoracic surgery, one-lung ventilation (OLV) is associated with hypoxemia, lung injury, and perioperative respiratory complications. The level of positive-end expiratory pressure (PEEP) to apply during OLV remains controversial. The open-lung approach consists in setting a level of PEEP corresponding to the best lung compliance, using an esophageal catheter to measure the transpulmonary pressure. This approach has been effective in laparoscopic surgeries or acute respiratory distress syndrome, but has never been evaluated in thoracic surgery.
Detailed description
Pulmonary resection surgery plays a key role in the treatment of localized lung cancer. During thoracic surgery, lung isolation is necessary. One-lung ventilation (OLV) is associated with frequent intraoperative respiratory complications, hypoxemia or lung injury related to mechanical ventilation. Intraoperative events increase the risk of postoperative complications resulting from either hypoxemia (atrial fibrillation, delirium, acute kidney injury) or lung injury (atelectasis, pulmonary edema, pneumonia, acute respiratory distress syndrome (ARDS)).
During OLV, a protective ventilation strategy is now recommended, including a low tidal volume (VT), using the lowest fraction of inspired oxygen (FiO2) due to the toxicity of high-oxygen concentration, and recruitment maneuvers (RM). But there is no consensus on the level of positive end-tidal pressure (PEEP) to apply. A low level of PEEP increases the risk of alveolar collapse, when a too high level leads to alveolar overdistension and increases lung dead space. The PEEP is usually arbitrary fixed to 5 cmH2O for every patient, which does not take into account the individual characteristics of the patient. Recent clinical trials in thoracic surgery showed that titration of PEEP according to the lowest airway driving pressure [end-inspiratory plateau pressure - total end-expiratory pressure], compared to a standard PEEP of 5 cmH2O, increased oxygenation and lung mechanics, and decreased significantly respiratory complications.
The transpulmonary pressure (PTP) is the instantaneous difference between alveolar pressure and pleural pressure. In order to optimize the alveolocapillary gas exchange, the level of PEEP should be titrated until achieving the best lung compliance (CL), defined by the ratio [(tidal volume) / (driving PTP = end-inspiratory PTP - end-expiratory PTP)]. As the tidal volume is set on the ventilator, the level of PEEP corresponding to the best CL is the one associated with the lowest driving PTP. The "open lung" strategy consists in setting the level of PEEP according to the best CL, which is an individualized approach, probably more physiologic than the standard care.
The esophageal pressure (PES) measured by an esophageal catheter is a validated estimation of the pleural pressure. Then, the PTP could be approximated by the difference [airway plateau pressure - PES]. The placement of an esophageal catheter is safe provided that the use respects contraindications (mainly esophageal disease or varices).
In ARDS, the open lung approach using an esophageal catheter was associated with a better clinical outcome than the standard non-individualized protocol. In laparoscopic surgery, the effects of PEEP on the PTP is also well described. In thoracic surgery, to date, monitoring PES and PTP is not part of the usual care. To our knowledge, only one study described the PTP changes during OLV. In this study, the best PEEP during OLV differed from one patient to another, which goes against the "one size fits all" theory. Thus, the PEEP should be titrated and individualized. Nevertheless, the airway driving pressure is only an approximation of the PTP, since it does not take into account the pleural pressure, which is a non-negligible extra-alveolar factor when talking about patients with lung or pleural diseases. Measuring the driving PTP using an esophageal catheter is certainly more accurate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- the "standard" protective ventilation versus an "open lung" protective ventilation protocol during a pulmonary resection surgery
| Arm | Type | Receives |
|---|---|---|
| "Standard" protective ventilation | Other | Procedure: "Standard" protective ventilation strategyPatients receiving a positive-end expiratory pressure (PEEP) of 5 cmH2O |
| "Open lung" protective ventilation protocol | Experimental | Procedure: "Open-lung" protective ventilation strategyPatients with a titrated positive-end expiratory pressure (PEEP) corresponding to the best lung compliance calculated with transpulmonary pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be over 18 years old,
- To be able to attend all scheduled visits and to comply with all trial procedures,
- To be scheduled for a lung cancer resection surgery (performed by either video-assisted thoracoscopy or thoracotomy).
Key exclusion criteria (19 listed)
- Non-carcinologic indication of lung resection (e.g. Lung volume reduction for bullous emphysema reduction, lung abscess),
- Bilateral pulmonary resection surgery or history of lung resection surgery,
- Lung resection under sternotomy
- Non intubated video-assisted thoracoscopy
- Robotic thoracic surgery
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 strategyIn the "open-lung" group, the positive end-tidal pressure (PEEP) is titrated to match the best lung compliance. During a "PEEP decrement trial", PEEP is decreased from 20 cmH2O to 4 cmH2O by steps of 2 cmH2O/minute, and the driving the transpulmonary pressure (PTP) is calculated at each level of PEEP. In the "open-lung" group, the targeted PEEP corresponds to the lowest driving PTP during the "PEEP decrement trial", meaning the best lung compliance. Thereafter, the PEEP is set at this level and maintained until extubation. | Procedure or surgery | "Open lung" protective ventilation protocol |
| "Standard" protective ventilation strategyIn the "standard" group, the positive end-tidal pressure (PEEP) is arbitrarily set at 5 cmH2O, since this is the currently recommended level of PEEP, commonly used in control groups of previous clinical trials. | Procedure or surgery | "Standard" protective ventilation |
Primary outcome
The incidence of intraoperative hypoxemia
Time frame: During the Open-Lung Ventilation (OLV) period
A SpO2<92% while the FiO2 is progressively decreased to 50% according to a standardized algorithm.
17 secondary outcomes
Hypoxemia events
Time frame: During the OLV period
The ventilatory parameters
Time frame: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
The ventilatory parameters
Time frame: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
The ventilatory parameters
Time frame: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
The ventilatory parameters
Time frame: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Blood gas analysis
Time frame: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Blood gas analysis
Time frame: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Blood gas analysis
Time frame: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Blood gas analysis
Time frame: T1: baseline, two-lung ventilation, before OLV ; Ts-OLV at the beginning of OLV ; T2: 45 minutes after OLV ; T3: at the end of OLV, before re-expansion and ventilation of the operated lung ; T4: at the end of surgery, before extubation
Intraoperative events related to hypoxemia
Time frame: During the OLV period
Intraoperative events related to hypoxemia
Time frame: During the OLV period
Intraoperative events related to hypoxemia
Time frame: During the OLV period
Intraoperative events related to hypoxemia
Time frame: During the OLV period
Intraoperative events not only due to hypoxemia
Time frame: During the OLV period
Postoperative respiratory complications until postoperative day 28
Time frame: Day 28
Non-respiratory postoperative complications until postoperative day-28 (POD28)
Time frame: Day 28
The hospital stay
Time frame: Day 28 and Day 90
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 31 Mar 2026.
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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 "Open-lung" protective ventilation strategy and "Standard" protective ventilation strategy in people with Lung Diseases, run by University Hospital, Montpellier 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 3 inclusion and 19 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 31 Mar 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 Hélène Dr DAVID (06.65.84.95.24 ext. +33, h-david@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of intraoperative hypoxemia (time frame: During the Open-Lung Ventilation (OLV) period). 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 31 Mar 2026.