Lung SurgeryOLVREEXPNCT07247500
Impact of Reventilation After One-Lung Ventilation in Thoracic Surgery (OLVREEXP)
A study testing Bipulmonary Reventilation using the accessory circuit in people with Lung Surgery, run by University Hospital, Rouen at 5 sites in France.
Trial summary
Lung cancer is a common disease, and more than 8,000 patients in France undergo lobectomy or pulmonary segmentectomy each year. This surgery remains associated with significant postoperative pulmonary complications, whose incidence ranges from 15% to 49% depending on the study (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Surgery
- What is being tested?
- Bipulmonary Reventilation using the accessory circuit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Jul 2026to 1 Aug 2028
- 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
- ASA score ≤ 3.
- Undergoing a scheduled video-assisted or robot-assisted lobectomy or segmentectomy.
- Patient has read and understood the information sheet and signed the informed consent form.
- For women of childbearing potential, effective contraception and confirmation of the absence of an ongoing pregnancy by a negative blood or urine pregnancy test are required.
- Postmenopausal women (spontaneous, non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
- Patient affiliated with a social security system.
Who cannot join
- Patients with a BMI > 40 kg/m².
- Patients with severe chronic respiratory failure (COPD grade 3, FEV₁/FVC < 0.7 and FEV₁ < 50% - according to the GOLD 2025 classification).
- Patients with severe chronic renal failure (GFR < 30 mL/min).
- Patients at high risk of conversion to thoracotomy.
- Patients with a history of acute respiratory distress syndrome (ARDS) within 3 months prior to surgery.
- Patients with a known history of severe hepatic failure (Child-Pugh class B or C).
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- Patients with a history of heart failure (NYHA class ≥ II).
- Patients with a history of pulmonary resection.
- Patients with uncontrolled asthma.
- Pregnant or breastfeeding women.
- Patients deprived of liberty by administrative or judicial decision, as well as those under legal protection, guardianship, or curatorship.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
CHU d'AMIENS
Amiens, 80054
Osama Abou Arab, Dr, 03 22 08 79 80, AbouArab.Osama@chu-amiens.fr
Osama Abou Arab, Dr
Clinique Victor Pauchet
Amiens, 80094
Pierre Huette, Dr, 03 22 33 71 05, huette.pierre@gmail.com
Pierre Huette, Dr
CHU de LILLE
Lille, 59037
Mouhamed Djahoum MOUSSA, Dr, 03 20 44 59 62, mouhamed.moussa@chru-lille.fr
Mouhamed Djahoum Moussa, Dr
CHU de ROUEN
Rouen, 76031
Jean Selim, Dr, jean.selim@chu-rouen.fr
Jean Selim, Dr
Hopital Foch
Suresnes, 92150
Morgan Le Guen, Dr, 01 46 25 24 33, s.martins@hopital-foch.com
Morgan Le Guen, Dr
About this study
Lung cancer is a common disease, and more than 8,000 patients in France undergo lobectomy or pulmonary segmentectomy each year. This surgery remains associated with significant postoperative pulmonary complications, whose incidence ranges from 15% to 49% depending on the study (1). The main complication is pulmonary atelectasis, which provides a favorable setting for the development of postoperative pneumonia.
In thoracic surgery, the operated lung is excluded, and one-lung ventilation is performed on the contralateral lung. During surgery, several strategies exist to prevent atelectasis during one-lung ventilation, known as protective ventilation strategies (2). At the end of the procedure, reventilation allows re-expansion of the previously excluded lung.
Read more
However, pulmonary reventilation induces the release of pro-inflammatory cytokines and causes endothelial dysfunction, which may lead to pulmonary edema, thereby negating the benefits of intraoperative protective ventilation. Conversely, insufficient re-expansion may result in persistent postoperative atelectasis, whereas excessive re-expansion can cause volutrauma, alveolar trauma, and/or barotrauma to the operated lung (3).
Several reventilation techniques are currently used, but to our knowledge, the impact of reventilation itself has never been specifically studied. The first, empirical technique, consists of reventilating both lungs using the accessory circuit and the adjustable pressure-limiting (APL) valve, manually bagging the patient over several respiratory cycles (4). The main drawback of this method is the lack of monitoring of insufflated volumes and pressures.
The second, more recent technique, consists of reventilating the patient using the anesthesia machine circuit in controlled ventilation mode, which allows for precise monitoring of pressures and insufflated volumes (5). This approach provides real-time monitoring of lung re-expansion and could therefore be less harmful than the empirical method.
Thus, the objective of this study is to compare postoperative pulmonary complications between patients who underwent lung re-expansion using the accessory circuit and those who underwent lung re-expansion using the anesthesia machine circuit in controlled ventilation mode.
- Conditions
- Lung Surgery
- Being tested
- Bipulmonary Reventilation using the accessory circuit, Bipulmonary Reventilation under controlled ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipulmonary Reventilation using the accessory circuitProcedure or surgery
Bipulmonary Reventilation using the accessory circuit
Bipulmonary Reventilation under controlled ventilationProcedure or surgery
Bipulmonary Reventilation under controlled ventilation
| Study group | Role | What they receive |
|---|---|---|
| Bipulmonary reventilation arm using the accessory circuit | Other | As lobectomy and segmentectomy are procedures of differing complexity, stratification according to the type of surgery will ensure a balanced distribution between the study groups. However, despite their differences, both procedures have similar operative durations and require complete atelectasis of the operated lung. The main distinction lies in the amount of pulmonary parenchyma removed (approximately 10% for segmentectomy and 30% for lobectomy).
This approach helps minimize bias related to variability in surgical procedures, as lobectomy is generally more invasive than segmentectomy. Consequently, each type of surgery will be represented comparably in both study groups. This stratification ensures that any differences observed between the groups can be attributed to the studied variable rather than to the type of surgical procedure. Receives: Procedure: Bipulmonary Reventilation using the accessory circuit |
| Bipulmonary reventilation arm under controlled ventilation | Experimental | As lobectomy and segmentectomy are procedures of differing complexity, stratification according to the type of surgery will ensure a balanced distribution between the study groups. However, despite their differences, both procedures have similar operative durations and require complete atelectasis of the operated lung. The main distinction lies in the amount of pulmonary parenchyma removed (approximately 10% for segmentectomy and 30% for lobectomy).
This approach helps minimize bias related to variability in surgical procedures, as lobectomy is generally more invasive than segmentectomy. Consequently, each type of surgery will be represented comparably in both study groups. This stratification ensures that any differences observed between the groups can be attributed to the studied variable rather than to the type of surgical procedure. Receives: Procedure: Bipulmonary Reventilation under controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
The evaluation of the primary endpoint will be performed by an anesthesiologist blinded to the lung re-expansion technique used.
The composite endpoint will consist of the occurrence, within the first 7 postoperative days, of at least one pulmonary complications (postoperative pneumonia, pleural effusion, postoperative atelectasis, pneumothorax, bronchospasm, or acute respiratory distress syndrome (ARDS)).
Measured: 7 postoperative days
Secondary outcomes (2)
Number of postoperative pulmonary complications
To compare the number of postoperative pulmonary complications between a group of patients who underwent a lung re-expansion technique using the accessory circuit and a group of patients who underwent a lung re-expansion technique using the machine circuit under controlled ventilation.
Measured: 7 postoperative days
Number of Death
To compare the death level between a group of patients who underwent a lung re-expansion technique using the accessory circuit and a group of patients who underwent a lung re-expansion technique using the machine circuit under controlled ventilation.
Measured: 30 postopeatives days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Jul 2026 (estimated)
- Primary completion8 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms in the study
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247500
- Sponsor's protocol ID
- 2023/0303/HP
- Other IDs
- 2025-A01698-41
- Acronym
- OLVREEXP
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reventilation After One-Lung Ventilation in Thoracic Surgery (OLVREEXP)
- ClinicalTrials.gov ID
- NCT07247500
- Acronym / sponsor ID
- OLVREEXP / 2023/0303/HP
- Conditions
- Lung Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 8 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 25 Nov 2025 (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.
Lung cancer is a common disease, and more than 8,000 patients in France undergo lobectomy or pulmonary segmentectomy each year. This surgery remains associated with significant postoperative pulmonary complications, whose incidence ranges from 15% to 49% depending on the study (1). The main complication is pulmonary atelectasis, which provides a favorable setting for the development of postoperative pneumonia.
In thoracic surgery, the operated lung is excluded, and one-lung ventilation is performed on the contralateral lung. During surgery, several strategies exist to prevent atelectasis during one-lung ventilation, known as protective ventilation strategies (2). At the end of the procedure, reventilation allows re-expansion of the previously excluded lung.
However, pulmonary reventilation induces the release of pro-inflammatory cytokines and causes endothelial dysfunction, which may lead to pulmonary edema, thereby negating the benefits of intraoperative protective ventilation. Conversely, insufficient re-expansion may result in persistent postoperative atelectasis, whereas excessive re-expansion can cause volutrauma, alveolar trauma, and/or barotrauma to the operated lung (3).
Several reventilation techniques are currently used, but to our knowledge, the impact of reventilation itself has never been specifically studied. The first, empirical technique, consists of reventilating both lungs using the accessory circuit and the adjustable pressure-limiting (APL) valve, manually bagging the patient over several respiratory cycles (4). The main drawback of this method is the lack of monitoring of insufflated volumes and pressures.
The second, more recent technique, consists of reventilating the patient using the anesthesia machine circuit in controlled ventilation mode, which allows for precise monitoring of pressures and insufflated volumes (5). This approach provides real-time monitoring of lung re-expansion and could therefore be less harmful than the empirical method.
Thus, the objective of this study is to compare postoperative pulmonary complications between patients who underwent lung re-expansion using the accessory circuit and those who underwent lung re-expansion using the anesthesia machine circuit in controlled ventilation mode.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms in the study
| Arm | Type | Receives |
|---|---|---|
| Bipulmonary reventilation arm using the accessory circuit | Other | Procedure: Bipulmonary Reventilation using the accessory circuitAs lobectomy and segmentectomy are procedures of differing complexity, stratification according to the type of surgery will ensure a balanced distribution between the study groups. However, despite their differences, both procedures have similar operative durations and require complete atelectasis of the operated lung. The main distinction lies in the amount of pulmonary parenchyma removed (approximately 10% for segmentectomy and 30% for lobectomy). This approach helps minimize bias related to variability in surgical procedures, as lobectomy is generally more invasive than segmentectomy. Consequently, each type of surgery will be represented comparably in both study groups. This stratification ensures that any differences observed between the groups can be attributed to the studied variable rather than to the type of surgical procedure. |
| Bipulmonary reventilation arm under controlled ventilation | Experimental | Procedure: Bipulmonary Reventilation under controlled ventilationAs lobectomy and segmentectomy are procedures of differing complexity, stratification according to the type of surgery will ensure a balanced distribution between the study groups. However, despite their differences, both procedures have similar operative durations and require complete atelectasis of the operated lung. The main distinction lies in the amount of pulmonary parenchyma removed (approximately 10% for segmentectomy and 30% for lobectomy). This approach helps minimize bias related to variability in surgical procedures, as lobectomy is generally more invasive than segmentectomy. Consequently, each type of surgery will be represented comparably in both study groups. This stratification ensures that any differences observed between the groups can be attributed to the studied variable rather than to the type of surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA score ≤ 3.
- Undergoing a scheduled video-assisted or robot-assisted lobectomy or segmentectomy.
- Patient has read and understood the information sheet and signed the informed consent form.
- For women of childbearing potential, effective contraception and confirmation of the absence of an ongoing pregnancy by a negative blood or urine pregnancy test are required.
- Postmenopausal women (spontaneous, non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
Key exclusion criteria (11 listed)
- Patients with a BMI > 40 kg/m².
- Patients with severe chronic respiratory failure (COPD grade 3, FEV₁/FVC < 0.7 and FEV₁ < 50% - according to the GOLD 2025 classification).
- Patients with severe chronic renal failure (GFR < 30 mL/min).
- Patients at high risk of conversion to thoracotomy.
- Patients with a history of acute respiratory distress syndrome (ARDS) within 3 months prior to 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 |
|---|---|---|
| Bipulmonary Reventilation using the accessory circuitBipulmonary Reventilation using the accessory circuit | Procedure or surgery | Bipulmonary reventilation arm using the accessory circuit |
| Bipulmonary Reventilation under controlled ventilationBipulmonary Reventilation under controlled ventilation | Procedure or surgery | Bipulmonary reventilation arm under controlled ventilation |
Primary outcome
Postoperative pulmonary complications
Time frame: 7 postoperative days
The evaluation of the primary endpoint will be performed by an anesthesiologist blinded to the lung re-expansion technique used. The composite endpoint will consist of the occurrence, within the first 7 postoperative days, of at least one pulmonary complications (postoperative pneumonia, pleural effusion, postoperative atelectasis, pneumothorax, bronchospasm, or acute respiratory distress syndrome (ARDS)).
2 secondary outcomes
Number of postoperative pulmonary complications
Time frame: 7 postoperative days
Number of Death
Time frame: 30 postopeatives days
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 9 Jun 2026.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipulmonary Reventilation using the accessory circuit in people with Lung Surgery, run by University Hospital, Rouen at 5 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 6 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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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 Nell Marty (0232888265, nell.marty@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: 7 postoperative days). 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 9 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.