Comparing Endotracheal Tube Cuff Pressure in Laparoscopic Abdominal Surgery: Saline vs. Air Infla… (NCT06089187) | Clinical Trial Compass
CompletedNot Applicable
Comparing Endotracheal Tube Cuff Pressure in Laparoscopic Abdominal Surgery: Saline vs. Air Inflation
Turkey (Türkiye)60 participantsStarted 2023-09-27
Plain-language summary
In this study, the investigators aim to compare the incidence of cuff pressure increase between endotracheal tubes inflated with air or saline during elective laparoscopic abdominal surgery under general anesthesia with N2O. This prospective observational study will be conducted on 60 patients aged 18-65 with ASA physical status I-II undergoing elective laparoscopic abdominal surgery under general anesthesia. Patients are randomly assigned to two groups: one group has tubes inflated with air (Group H, n=30), while the other group has tubes inflated with saline (Group S, n=30). The cuff pressure is continuously monitored using a pressure transducer attached to the cuff via a three-way tap. Anesthesia maintenance is achieved with sevoflurane and oxygen/N2O (%40/%60) in both groups. The intervention is performed whenever the cuff pressure exceeds 20 mmHg for \>30 seconds during the CO2 insufflation of the abdomen, and the pressure is reduced. The number of interventions is recorded as the primary outcome of the study. The cuff pressure is measured before and after insufflation and after the patients are placed in Trendelenburg and reverse Trendelenburg positions.
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:
* aged 18-65,
* American Society of Anesthesiologists physical status 1 or 2
* Expected surgery time of 30-120 minutes,
* Scheduled for elective laparoscopic abdominal surgery
Exclusion Criteria:
* neuropsychiatric disease
* muscle disease
* serious cardiovascular and respiratory system disease
* upper respiratory tract infection in the last 14 days
* morbid obesity
* alcohol or substance addiction
* history of bronchospasm
* expectation of difficult intubation
* history of tracheostomy
* history of laryngeal disease or surgery.
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.