Predictive Value of Intraoperative Ventilatory Leak Flow in Prolonged Alveolar Air Leak After Lung Resection Surgery

NCT ID: NCT03742739

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-29

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pronlongated Alveolar Air Leak (PAAL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre SENTENAC, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Department of Anesthesie Reanimation

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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UF 7700

Identifier Type: -

Identifier Source: org_study_id