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Recruiting NCT07350265

NCT07350265 Prospective Study Evaluating the Effectiveness of Intraoperative Ventilation for Predicting Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy

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Clinical Trial Summary
NCT ID NCT07350265
Status Recruiting
Phase
Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Condition Air Leak From Lung
Study Type OBSERVATIONAL
Enrollment 100 participants
Start Date 2026-01-14
Primary Completion 2026-12

Trial Parameters

Condition Air Leak From Lung
Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-14
Completion 2026-12
Interventions
No Intervention: Observational Cohort

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Brief Summary

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.

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.

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