Actively Recruiting

Age: 18Years +
All Genders
ID07350265

Prospective Study Evaluating Intraoperative Ventilation to Predict Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy

Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2026-03-30

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Air leaks from the lung after major pulmonary surgeries such as lobectomy or anatomical segmentectomy are caused by small openings in the lung lining due to surgical damage. These air leaks are common and can lead to prolonged hospital stays and increased healthcare costs. Although the leaks themselves are painless, the treatments required, like chest drains, often cause significant discomfort and can complicate recovery. Advances in minimally invasive lung surgery have made traditional air leak detection methods less effective, creating the need for new ways to identify leaks during surgery. This study evaluates the use of intraoperative ventilation measurements to detect and predict air leaks during lung surgery performed by conventional or robotic thoracoscopy. Each patient will receive standard care with routine intraoperative ventilation and postoperative chest drainage to manage air leaks. Researchers aim to find a correlation between the volume of air leakage measured during surgery and after surgery, potentially identifying patients who might avoid chest drains and thus reduce postoperative pain and hospital time. Participants will be monitored from the time of surgery until four weeks after, with researchers assessing the air leak volumes during and after the procedure. This includes routine follow-up care involving chest drains and observation of any complications. The primary outcome is the correlation between intraoperative and postoperative air leak volumes, which will help guide future care to improve recovery and reduce discomfort following lung surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with pulmonary lobectomy or anatomical segmentectomy using closed chest surgery (conventional or robotic thoracoscopy)
  • Patient affiliated with a health insurance scheme
  • Person who has not objected to the collection of their data for the purpose of the study
Not Eligible

You will not qualify if you...

  • Patient undergoing any lung resection by thoracotomy
  • Patient with history of thoracic surgery on the same side
  • Patient with pulmonary fibrosis
  • Patient from a vulnerable population as defined in French Public Health Code articles L.1121-5 to 8
  • Patient undergoing conversion to thoracotomy
  • Patient undergoing conversion from planned lobectomy or segmentectomy to atypical resection, bilobectomy, or pneumonectomy
  • Use of two chest drains for drainage
  • Absence of autonomous drainage system
  • Patient not extubated at the end of the procedure
  • Early reoperation before drain removal due to complications

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate post-operative period

Participants undergo major lung resection by conventional or robotic thoracoscopy. During surgery, intraoperative ventilation is used to diagnose air leaks. After surgery, participants receive routine post-operative care including installation of chest drains.

1 surgical visit and hospital stay for post-operative care

Post-operative Follow-up

Duration - Up to 4 weeks after surgery

Participants are monitored for post-operative air leaks and recovery following lung resection surgery.

Approximately 3 to 4 follow-up visits during the 4 weeks post-surgery

Trial Site Locations

Total: 1 location

1

Hôpital privé d'Anthony

Antony, France, 92160

Actively Recruiting

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Research Team

D

Dr Madalina GRIGOROIU

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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.

Madalina Grigoroiu, Emmanuel Brian, Elisabeth Gauci...

https://pubmed.ncbi.nlm.nih.gov/41988303