Tracheal Cuff Pressure and Postoperative Complications
Brazil362 participantsStarted 2026-01-05
Plain-language summary
This prospective observational study aims to identify risk factors for tracheal mucosal injuries caused by orotracheal tube use during the intraoperative period in patients undergoing elective surgeries at the Hospital de Clínicas de Porto Alegre. The study will recruit patients sequentially for elective procedures requiring general anesthesia and orotracheal intubation. Primary outcomes include symptoms such as hoarseness, pharyngolaryngeal pain, cough, and hemoptysis, assessed up to 30 days post-surgery. A risk score for tracheal injuries will be derived.
Who can participate
Age range
18 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:
* Age greater than 18 years.
* Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
Exclusion Criteria:
* Age less than 18 years.
* Refusal to participate in the study.
* Surgeries performed on an urgent or emergency basis.
* Surgeries in pregnant women.
* Cardiac surgeries.
* Surgeries requiring single-lung ventilation.
* Head and neck surgeries.
* Surgeries on the cervical segment of the dorsal spine.
* Surgeries requiring lateral or prone positioning.
* Anticipated difficult airway (unanticipated difficult airways will be included).
* Insufficient fasting time.
* Surgeries in patients admitted to intensive care units.
* Patients presenting the same symptoms included in the outcomes to be measured (pre-existing hoarseness, pain, cough, hemoptysis).
* Tracheostomized patients or those with previous tracheobronchial segment lesions.
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
Presence of Tracheal Injury Symptoms (Composite Outcome).
Timeframe: First 24 hours post-op to 30 days post-op