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

Overview

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.

Interventions

• Other No Intervention: Observational Cohort
  No intervention : Observational Cohort

Primary outcome measures

• correlation between intraoperative air leak volume and post-operative air leakage volume [Time frame: From enrollment to the study completion at 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Hôpital privé d'Anthony — Antony

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. PMID 41988303

Identifiers

NCT: NCT07350265 · COS-RGDS-2024-06-015-P-GRIGORO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗