Air Leak From LungNODRAINNCT07350265
Prospective Study Evaluating the Effectiveness of Intraoperative Ventilation for Predicting Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy
An observational study of Air Leak From Lung and Lung Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Air leak from lung after major pulmonary resections is alveolar-pleural microfistulas resulting from damage to the visceral pleura during lung surgery. Despite advances in stapling techniques and repair methods to ensure pulmonary tightness after excision, air leak is the most common cause of prolonged hospital stay… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Air Leak From Lung, Lung Surgery
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2026to Dec 2026
- Phase
- Observational
- 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
Study population: The eligible study population will consist of patients aged 18 years and older undergoing major lung resection by conventional or robotic thoracoscopy.
Who may be able to join
- Patient with pulmonary lobectomy or Anatomical segmentectomy with closed chest (conventional or robotic thoracoscopy);
- Patient affiliated with a health insurance scheme.
- Person who has not objected to the collection of his/her data for the purpose of the study.
Who cannot join
- Patient undergoing any type of lung resection by thoracotomy;
- Patient with a history of thoracic surgery on the same side;
- Patient with pulmonary fibrosis;
- Patient from a vulnerable population as defined in Articles L.1121-5 to 8 of the French Public Health Code.
- Patient undergoing conversion to thoracotomy;
- Patient undergoing conversion from planned pulmonary lobectomy or anatomical segmentectomy to atypical resection, bilobectomy or pneumonectomy;
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- Drainage via two chest drains;
- Absence of autonomous drainage system;
- Patient not extubated at the end of the procedure;
- Early reoperation, before drain removal, due to complications.
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
Hôpital privé d'Anthony
Antony, 92160
Madalina GRIGOROIU Dr GRIGOROIU Madalina, +33 146 74 23 74, madalina.grigoroiu@gmail.com
About this study
Air leak from lung after major pulmonary resections is alveolar-pleural microfistulas resulting from damage to the visceral pleura during lung surgery. Despite advances in stapling techniques and repair methods to ensure pulmonary tightness after excision, air leak is the most common cause of prolonged hospital stay after lung surgery, accounting for 20 to 30% of post-surgical adverse events.
Although painless, they remain a significant source of morbidity. 10 to 20% of patients may have a prolonged air leak requiring intervention. Prolonged air leak is defined as an air leakage that persists for 5 days or more. Prolonged air leak is independently associated with increased hospitalization costs of 18% to 27% according to the series reported in the literature, but also with increased costs after hospital discharge, up to 90 days postoperatively.
Read more
Traditionally, the detection of air leak at the end of surgery is done by testing the lung for submersion in saline solution. With the development of major pulmonary resection techniques by conventional or robotic thoracoscopy (with closed chest), this method has become ineffective because it requires re-ventilating the lung in a closed rib cage, which cancels the visibility of the camera. However, the frequency of these adverse events and the morbidity associated with them now induces the placement of post-operative drains, which are very painful, unlike the leak itself, which makes the pain even more complex to bear for patients.
Given the rapid transition to a minimally invasive surgical approach, having a method to detect and quantify intraoperative air leak on a closed chest is necessary in order to accelerate patients' postoperative recovery, reducing their postoperative pain while controlling the incidence of complications.
A recent study has shown that the risk of postoperative air leak is possible based exclusively on intraoperative ventilator measurements, but the data are still too scarce to rely on them extensively.
Read the detailed description
In this NODRAIN study, we aim to evaluate the effectiveness of intraoperative ventilation for the detection of intraoperative air leak from lung. Therefore, the main objective of this study is to investigate the effectiveness of intraoperative ventilation for the prediction of postoperative air leak.
Each patient will receive intraoperative ventilation, conducted for the diagnosis of air leak in routine practice, as well as their routine post-operative care, which is the installation of drains. The demonstration of a correlation will make it possible to determine a threshold for identifying patients for whom drainage would not be necessary, thus reducing their post-operative pain, the duration and the cost of hospitalization.
- Conditions
- Air Leak From Lung, Lung Surgery
- Being tested
- No Intervention: Observational Cohort
- Keywords
- intraoperative ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention : Observational Cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between intraoperative air leak volume and post-operative air leakage volume
The primary endpoint is the correlation between intraoperative air leak volume, measured by the ventilator, and postoperative air leak volume, measured by the digitalized autonomous drainage system on the patient's postoperative drain after extubation.
Measured: From enrollment to the study completion at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start14 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Air Leak From LungStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Madalina GRIGOROIU, Principal investigator, Hôpital Privé d'Antony
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350265
- Sponsor's protocol ID
- COS-RGDS-2024-06-015-P-GRIGORO
- Acronym
- NODRAIN
- Status last verified
- Mar 2026
- First submitted
- 22 Sep 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grigoroiu M, Brian E, Gauci E, Hafiani M. NODRAIN study protocol: a non-interventional, prospective study for evaluating the effectiveness of intraoperative ventilation for the prediction of postoperative air leak in major pulmonary resections by conventional or robotic thoracoscopy. J Thorac Dis. 2026 Mar 31;18(3):255. doi: 10.21037/jtd-2025-1-2424. Epub 2026 Mar 16.
PubMed 41988303
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Effectiveness of Intraoperative Ventilation for Predicting Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy
- ClinicalTrials.gov ID
- NCT07350265
- Acronym / sponsor ID
- NODRAIN / COS-RGDS-2024-06-015-P-GRIGORO
- Conditions
- Air Leak From Lung, Lung Surgery
- Keywords
- intraoperative ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
Air leak from lung after major pulmonary resections is alveolar-pleural microfistulas resulting from damage to the visceral pleura during lung surgery. Despite advances in stapling techniques and repair methods to ensure pulmonary tightness after excision, air leak is the most common cause of prolonged hospital stay after lung surgery, accounting for 20 to 30% of post-surgical adverse events.
Although painless, they remain a significant source of morbidity. 10 to 20% of patients may have a prolonged air leak requiring intervention. Prolonged air leak is defined as an air leakage that persists for 5 days or more. Prolonged air leak is independently associated with increased hospitalization costs of 18% to 27% according to the series reported in the literature, but also with increased costs after hospital discharge, up to 90 days postoperatively.
Traditionally, the detection of air leak at the end of surgery is done by testing the lung for submersion in saline solution. With the development of major pulmonary resection techniques by conventional or robotic thoracoscopy (with closed chest), this method has become ineffective because it requires re-ventilating the lung in a closed rib cage, which cancels the visibility of the camera. However, the frequency of these adverse events and the morbidity associated with them now induces the placement of post-operative drains, which are very painful, unlike the leak itself, which makes the pain even more complex to bear for patients.
Given the rapid transition to a minimally invasive surgical approach, having a method to detect and quantify intraoperative air leak on a closed chest is necessary in order to accelerate patients' postoperative recovery, reducing their postoperative pain while controlling the incidence of complications.
A recent study has shown that the risk of postoperative air leak is possible based exclusively on intraoperative ventilator measurements, but the data are still too scarce to rely on them extensively.
Detailed description
In this NODRAIN study, we aim to evaluate the effectiveness of intraoperative ventilation for the detection of intraoperative air leak from lung. Therefore, the main objective of this study is to investigate the effectiveness of intraoperative ventilation for the prediction of postoperative air leak.
Each patient will receive intraoperative ventilation, conducted for the diagnosis of air leak in routine practice, as well as their routine post-operative care, which is the installation of drains. The demonstration of a correlation will make it possible to determine a threshold for identifying patients for whom drainage would not be necessary, thus reducing their post-operative pain, the duration and the cost of hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible study population will consist of patients aged 18 years and older undergoing major lung resection by conventional or robotic thoracoscopy.
Key inclusion criteria (3 listed)
- Patient with pulmonary lobectomy or Anatomical segmentectomy with closed chest (conventional or robotic thoracoscopy);
- Patient affiliated with a health insurance scheme.
- Person who has not objected to the collection of his/her data for the purpose of the study.
Key exclusion criteria (10 listed)
- Patient undergoing any type of lung resection by thoracotomy;
- Patient with a history of thoracic surgery on the same side;
- Patient with pulmonary fibrosis;
- Patient from a vulnerable population as defined in Articles L.1121-5 to 8 of the French Public Health Code.
- Patient undergoing conversion to thoracotomy;
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention : Observational Cohort | Other | – |
Primary outcome
correlation between intraoperative air leak volume and post-operative air leakage volume
Time frame: From enrollment to the study completion at 4 weeks
The primary endpoint is the correlation between intraoperative air leak volume, measured by the ventilator, and postoperative air leak volume, measured by the digitalized autonomous drainage system on the patient's postoperative drain after extubation.
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 30 Mar 2026.
- Derived from this study: PubMed 41988303Grigoroiu M, Brian E, Gauci E, Hafiani M. NODRAIN study protocol: a non-interventional, prospective study for evaluating the effectiveness of intraoperative ventilation for the prediction of postoperative air leak in major pulmonary resections by conventional or robotic thoracoscopy. J Thorac Dis. 2026 Mar 31;18(3):255. doi: 10.21037/jtd-2025-1-2424. Epub 2026 Mar 16.
- Individual participant dataSharing planned: Undecided
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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.
Dr Madalina GRIGOROIU principal investigator
Hôpital Privé d'Antony
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Air Leak From Lung and Lung Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 10 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 30 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 Dr Madalina GRIGOROIU ((0)7 60 39 19 10 ext. + 33, madalina.grigoroiu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between intraoperative air leak volume and post-operative air leakage volume (time frame: From enrollment to the study completion at 4 weeks). 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 NCT07350265, which also lists 1 linked publication.
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 30 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.