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CompletedNCT03742739AIR-LEAKUpdated Oct 19, 2021

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

An observational study in Pronlongated Alveolar Air Leak (PAAL), sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pronlongated Alveolar Air Leak (PAAL)
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 days after operation

Secondary outcomes

  1. clinical features

    Collection of clinical features to identify risk factors for PAAL

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

07

Study locations

1 site
  • Department of Anesthesie Reanimation
    Montpellier, 34295, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03742739
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Nov 15, 2018
Start date
Jan 29, 2019
Primary completion
Mar 1, 2021
Completion
Aug 1, 2021
Last update
Oct 19, 2021

Study contacts

Pierre SENTENAC, Dr
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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