Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With… (NCT06180148) | Clinical Trial Compass
CompletedNot Applicable
Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation
Russia31 participantsStarted 2024-01-09
Plain-language summary
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The study aimed to compare the effectiveness of using a mechanical insufflator-exsufflator after video-assisted thoracoscopic surgery using one-lung ventilation to reduce postoperative pulmonary complications as compared to standard therapy.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Video-assisted thoracoscopic surgery using one-lung ventilation
* Age 18-65 years Forced expiratory volume in one second (FEV1) 60% of predicted or more
* Absence of pronounced bronchial secretion before surgery
* Written informed consent.
Exclusion Criteria:
* Age less than 18 and more than 65 years
* Presence of pneumothorax 6 hours after surgery on radiography
* Pulmonary hemorrhage of any intensity
* Unstable hemodynamics
* Forced expiratory volume in one second (FEV1) is less than 60% of predicted during preoperative examination
* The scope of the operation is more than a lobectomy
* Bilateral and combined operations
* Mechanical ventilation after surgery for more than 6 hours
* Anesthesia risk according to American Society of Anesthesiologists (ASA) 4 and 5 points
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation
Timeframe: On 6 hour after operation
2
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation
Timeframe: On 24 hour after operation
3
Sputum volume 24 hours after tracheal extubation
Timeframe: On 24 hour after operation
4
Peak expiratory flow (PEF) 48 hours after surgery
Timeframe: On 48 hour after operation
5
The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
Timeframe: On 36-48 hour after operation
Trial details
NCT IDNCT06180148
SponsorI.M. Sechenov First Moscow State Medical University