Using intraoperative ventilation to predict postoperative air leaks after thoracoscopic lobectomy or segmentectomy

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

This project will try using intraoperative ventilation during thoracoscopic lobectomy or segmentectomy to see if it can predict which patients will have postoperative air leaks.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 1 site (Antony)
• Trial ID: NCT07350265 on ClinicalTrials.gov

What this trial studies

In the NODRAIN observational cohort, patients undergoing conventional or robotic thoracoscopic lobectomy or anatomical segmentectomy will receive a standardized intraoperative ventilation maneuver to detect air leaks at the end of the operation. Surgeons will still place routine chest drains and patients will receive standard postoperative care while intraoperative findings and postoperative air-leak duration are recorded. Investigators will analyze the correlation between intraoperative ventilation results and the occurrence or persistence of postoperative air leaks to identify a predictive threshold. Demonstrating a reliable threshold could allow some patients to avoid chest drains, reducing pain, length of stay, and costs.

Who should consider this trial

Good fit: Adults scheduled for conventional or robotic thoracoscopic pulmonary lobectomy or anatomical segmentectomy with a closed chest who agree to data collection are ideal candidates.

Not a fit: Patients undergoing thoracotomy, with prior same-side thoracic surgery, pulmonary fibrosis, conversions to open surgery or more extensive resection, absence of an autonomous drainage system, or failure to be extubated at the end of the procedure are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could identify patients who safely don't need chest drains after thoracoscopic lung resection, reducing pain, hospital stay, and costs.

How similar studies have performed: Traditional saline submersion leak tests are widely used, but using intraoperative ventilation measurements to predict postoperative prolonged air leak is relatively novel and has limited large-scale confirming evidence.

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.

Where this trial is running

Antony

• Hôpital privé d'Anthony — Antony, France (Recruiting)

Study contacts

• Principal investigator: Dr Madalina GRIGOROIU — Hôpital Privé d'Antony
• Study coordinator: Dr Madalina GRIGOROIU

Conditions Air Leak From Lung; Lung Surgery; intraoperative ventilation