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OpenTrials
Completed

NCT Number: NCT03742739

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

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.

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Key information

Conditions

Pronlongated Alveolar Air Leak (PAAL)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesie Reanimation

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PAAL after pulmonary resection surgery

    Time frame: 5 days after operation

    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.

Secondary outcomes

  1. clinical features

    Time frame: up to 28 days after the pulmonary resection surgery

    Collection of clinical features to identify risk factors for PAAL

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: AIR-LEAK

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 15, 2018
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.