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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.

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Sites and contacts
Official record
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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
  • Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve

    Montpellier, 34090

    Hélène DAVID, Doctor

    Recruiting

Other trials in France

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 groups in NCT05525312
Study groupRoleWhat they receive
"Standard" protective ventilationOtherPatients receiving a positive-end expiratory pressure (PEEP) of 5 cmH2O
Receives: Procedure: "Standard" protective ventilation strategy
"Open lung" protective ventilation protocolExperimentalPatients 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.

  1. 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)
  1. Hypoxemia events

    The number of hypoxemia events, depth, and duration of hypoxemia.

    Measured: During the OLV period

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Intraoperative events related to hypoxemia

    Additional recruitment maneuvers (cmH2O)

    Measured: During the OLV period

  11. Intraoperative events related to hypoxemia

    Additional bronchoscopy

    Measured: During the OLV period

  12. Intraoperative events related to hypoxemia

    Application of a selective PEEP to the operated lung using an auxiliary valve

    Measured: During the OLV period

  13. Intraoperative events related to hypoxemia

    Re-expansion and ventilation of the operated lung performed for hypoxemia

    Measured: During the OLV period

  14. 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

  15. 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

  16. 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

  17. 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.

  1. First posted1 Sep 2022
  2. Study start20 Mar 2024
  3. Primary completion20 Mar 2027 (estimated)
  4. Study completion20 Jun 2027 (estimated)

Resources

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)
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

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.

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