Lung InjuryOLVEELVNCT06446544
Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation: a Randomized Study
A study testing VPFE monitoring with intraoperative alveolar recruitment maneuvers. in people with Lung Injury, run by University Hospital, Rouen at 1 site in France.
Trial summary
In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Injury
- What is being tested?
- VPFE monitoring with intraoperative alveolar recruitment maneuvers.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteFrance
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients aged 76 and over
- COPD patients (Gold stage 3 or 4 of the 2023 Gold classification)
- Patients with a history of ischemic coronary artery disease
- Patients with a history of pulmonary emphysema bubbles on the ventilated lung
- Tracheostomized patient
- Obese patients (>30 kg/m²)
Show all 13Show fewer
- Patients with a history of pulmonary resection
- ASA patients ≥4
- Patient benefiting from a pre-operative rehabilitation protocol with physiotherapy
- Pregnant or parturient or breastfeeding woman or proven absence of contraception
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent
- Patient refusing to give consent.
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
CHU de ROUEN
Rouen, 76031
Jean Selim, Dr, jean.selim@chu-rouen.fr
Jean Selim, Dr
About this study
In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.
Strategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.
Read more
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.
The effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and/or more intensive respiratory rehabilitation program with the physiotherapy team.
Read the detailed description
In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.
Strategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.
The effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and/or more intensive respiratory rehabilitation program with the physiotherapy team.
- Conditions
- Lung Injury
- Being tested
- VPFE monitoring with intraoperative alveolar recruitment maneuvers.
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPFE monitoring with intraoperative alveolar recruitment maneuvers.Procedure or surgery
VPFE monitoring with intraoperative alveolar recruitment maneuvers.
VPFE monitoring with intraoperative alveolar recruitment maneuvers.Procedure or surgery
VPFE monitoring with intraoperative alveolar recruitment maneuvers.
| Study group | Role | What they receive |
|---|---|---|
| arm monitoring of the VPFE with intraoperative alveolar recruitment maneuvers | Experimental | arm monitoring of the VPFE with intraoperative alveolar recruitment maneuvers Receives: Procedure: VPFE monitoring with intraoperative alveolar recruitment maneuvers. |
| VPFE monitoring arm without intraoperative alveolar recruitment maneuvers. | Placebo comparator | VPFE monitoring arm without intraoperative alveolar recruitment maneuvers. Receives: Procedure: VPFE monitoring with intraoperative alveolar recruitment maneuvers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of VPFE monitoring with intraoperative alveolar recruitment maneuvers compared to VPFE monitoring without intraoperative alveolar recruitment maneuvers on pulmonary aeration of the ventilated lung
The primary endpoint will be the value of the LUS (Lung Ultrasound Score) score on the ventilated lung at the time of lung ultrasound in SSPI, 30 minutes after extubation (presence of atelectasis with a LUS score > or = 10/18).
Measured: 30 min post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 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 InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT06446544
- Sponsor's protocol ID
- 2021/0383/HP
- Acronym
- OLVEELV
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2024
- 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
- Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation: a Randomized Study
- ClinicalTrials.gov ID
- NCT06446544
- Acronym / sponsor ID
- OLVEELV / 2021/0383/HP
- Conditions
- Lung Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 6 Jun 2024 (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.
In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.
Strategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.
The effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and/or more intensive respiratory rehabilitation program with the physiotherapy team.
Detailed description
In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.
Strategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.
The effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and/or more intensive respiratory rehabilitation program with the physiotherapy team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm monitoring of the VPFE with intraoperative alveolar recruitment maneuvers | Experimental | Procedure: VPFE monitoring with intraoperative alveolar recruitment maneuvers.arm monitoring of the VPFE with intraoperative alveolar recruitment maneuvers |
| VPFE monitoring arm without intraoperative alveolar recruitment maneuvers. | Placebo comparator | Procedure: VPFE monitoring with intraoperative alveolar recruitment maneuvers.VPFE monitoring arm without intraoperative alveolar recruitment maneuvers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Patients aged 76 and over
- COPD patients (Gold stage 3 or 4 of the 2023 Gold classification)
- Patients with a history of ischemic coronary artery disease
- Patients with a history of pulmonary emphysema bubbles on the ventilated lung
- Tracheostomized patient
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 |
|---|---|---|
| VPFE monitoring with intraoperative alveolar recruitment maneuvers.VPFE monitoring with intraoperative alveolar recruitment maneuvers. | Procedure or surgery | arm monitoring of the VPFE with intraoperative alveolar recruitment maneuvers |
| VPFE monitoring with intraoperative alveolar recruitment maneuvers.VPFE monitoring with intraoperative alveolar recruitment maneuvers. | Procedure or surgery | VPFE monitoring arm without intraoperative alveolar recruitment maneuvers. |
Primary outcome
Evaluate the effect of VPFE monitoring with intraoperative alveolar recruitment maneuvers compared to VPFE monitoring without intraoperative alveolar recruitment maneuvers on pulmonary aeration of the ventilated lung
Time frame: 30 min post-extubation
The primary endpoint will be the value of the LUS (Lung Ultrasound Score) score on the ventilated lung at the time of lung ultrasound in SSPI, 30 minutes after extubation (presence of atelectasis with a LUS score > or = 10/18).
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPFE monitoring with intraoperative alveolar recruitment maneuvers. in people with Lung Injury, run by University Hospital, Rouen 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 0 inclusion and 13 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 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. Some participants in this study may receive a placebo. 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 David Mallet (02 32 88 82 65, 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?
Evaluate the effect of VPFE monitoring with intraoperative alveolar recruitment maneuvers compared to VPFE monitoring without intraoperative alveolar recruitment maneuvers on pulmonary aeration of the ventilated lung (time frame: 30 min post-extubation). 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.