Prospective Study Evaluating the Effectiveness of Intraoperative Ventilation for Predicting Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy (NODRAIN)

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Surgery; Air Leak From Lung
• Intervention / Treatment: Other: No Intervention: Observational Cohort

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dr Madalina GRIGOROIU; Phone Number: + 33 (0)7 60 39 19 10; Email: madalina.grigoroiu@gmail.com

Study Locations

• France
  • Antony, France, 92160
    • Recruiting
    • Hôpital privé d'Anthony
    • Contact: Madalina GRIGOROIU Dr GRIGOROIU Madalina; Phone Number: +33 146 74 23 74; Email: madalina.grigoroiu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The eligible study population will consist of patients aged 18 years and older undergoing major lung resection by conventional or robotic thoracoscopy.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Dr Madalina GRIGOROIU, Hopital Prive d'Antony

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: intraoperative ventilation
• Other Study ID Numbers: COS-RGDS-2024-06-015-P-GRIGORO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No