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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03742739

Acronym

AIR-LEAK

Enrollment

300

Registered

2018-11-15

Start date

2019-01-29

Completion date

2021-08-01

Last updated

2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pronlongated Alveolar Air Leak (PAAL)

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PAAL after pulmonary resection surgery	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

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

Countries

France

Outcome results