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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No intervention : Observational Cohort |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the study completion at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The eligible study population will consist of patients aged 18 years and older undergoing major lung resection by conventional or robotic thoracoscopy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Madalina GRIGOROIU | Contact | (0)7 60 39 19 10 | + 33 | madalina.grigoroiu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Madalina GRIGOROIU | Hôpital Privé d'Antony | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital privé d'Anthony | Recruiting | Antony | 92160 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41988303 | Derived | 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. |
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