Pronlongated Alveolar Air Leak (PAAL)AIR-LEAKNCT03742739
Predictive Value of Intraoperative Ventilatory Leak Flow in Prolonged Alveolar Air Leak After Lung Resection Surgery
An observational study of Pronlongated Alveolar Air Leak (PAAL), run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pronlongated Alveolar Air Leak (PAAL)
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2019to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients scheduled for pulmonary resection surgery by videothoracoscopy or thoracotomy (including pulmonary wedge resection, segmentectomy, lobectomy, bilobectomy, pneumonectomy).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Ventilatory Leak Flow to Predict Prolonged Alveolar Air Leak After Lung Resection Surgery: a Prospective Study
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.
- Conditions
- Pronlongated Alveolar Air Leak (PAAL)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days after operation
Secondary outcomes (1)
clinical features
Collection of clinical features to identify risk factors for PAAL
Measured: up to 28 days after the pulmonary resection surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start29 Jan 2019
- Primary completion1 Mar 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pronlongated Alveolar Air Leak (PAAL)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre SENTENAC, Dr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742739
- Sponsor's protocol ID
- UF 7700
- Acronym
- AIR-LEAK
- Status last verified
- Mar 2021
- First submitted
- 8 Nov 2018
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ventilatory Leak Flow to Predict Prolonged Alveolar Air Leak After Lung Resection Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT03742739
- Acronym / sponsor ID
- AIR-LEAK / UF 7700
- Conditions
- Pronlongated Alveolar Air Leak (PAAL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients scheduled for pulmonary resection surgery by videothoracoscopy or thoracotomy (including pulmonary wedge resection, segmentectomy, lobectomy, bilobectomy, pneumonectomy).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
clinical features
Time frame: up to 28 days after the pulmonary resection surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre SENTENAC, Dr principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pronlongated Alveolar Air Leak (PAAL), run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAAL after pulmonary resection surgery (time frame: 5 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.