Pronlongated Alveolar Air Leak (PAAL) Clinical Trial
— AIR-LEAKOfficial title:
Intraoperative Ventilatory Leak Flow to Predict Prolonged Alveolar Air Leak After Lung Resection Surgery: a Prospective Study
| NCT number | NCT03742739 |
| Other study ID # | UF 7700 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 29, 2019 |
| Est. completion date | August 1, 2021 |
| Verified date | March 2021 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | August 1, 2021 |
| Est. primary completion date | March 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Department of Anesthesie Reanimation | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | clinical features | Collection of clinical features to identify risk factors for PAAL | up to 28 days after the pulmonary resection surgery |