Predictive Value of Intraoperative Ventilatory Leak Flow in Prolonged Alveolar Air Leak After Lung Resection Surgery (AIR-LEAK)

Intraoperative Ventilatory Leak Flow to Predict Prolonged Alveolar Air Leak After Lung Resection Surgery: a Prospective Study

After lung resection surgery, patients usually receive a postoperative pleural drain. Prolongated alveolar air leak (PAAL) is a frequent complication after lung surgery (6 to 26% of patients), defined by the European Society of Thoracic Surgeons (ESTS) as a duration of drainage greater than or equal to five days. PAAL is most often due to prolongated bubbling of the drain. Prolonged drainage is a leading cause of prolongated hospital stay, increasing care costs.

The risk of prolongated drainage can not be predicted with sufficient accuracy. Existing risk scores for PAAL do not take into account the intraoperative ventilatory leakage (IVL). IVL is a parameter displayed on the ventilator (anaesthetic machine that make the patient breathing during surgical procedure). There is new evidences suggesting that IVL could predict the risk of PAAL after lung resection surgery, but these data have to be supplemented by a well conducted prospective study.

Study Overview

• Status: Completed
• Conditions: Pronlongated Alveolar Air Leak (PAAL)

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Department of Anesthesie Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients scheduled for pulmonary resection surgery by videothoracoscopy or thoracotomy (including pulmonary wedge resection, segmentectomy, lobectomy, bilobectomy, pneumonectomy).

Description

Inclusion criteria:

• To be 18 years old or older
• To be of French nationality or native from an European country affiliated to the French health care system
• To be scheduled for pulmonary resection surgery by videothoracoscopy or thoracotomy in the center of the study

Exclusion criteria:

• Patient minor, or major under legal protection, or enable to give consent
• Refusal or consent withdrawal
• No pulmonary resection or no pleural drain at the end of the surgical procedure (decided by the surgical team)
• Postoperative pleural fistula

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAAL after pulmonary resection surgery	End of bubbling is assessed by the nursing team in charge of the patient in accordance with the current practice (no bubbling at forced expiration), and validated by the physician in charge.	5 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical features	Collection of clinical features to identify risk factors for PAAL	up to 28 days after the pulmonary resection surgery

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Pierre SENTENAC, Dr, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UF 7700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No