Tracheal Tube Cuff Pressure and Postoperative Hoarseness and Pain
Official title: Tracheal Cuff Pressure and Postoperative Complications: Prospective Observational Study.
Run by Hospital de Clinicas de Porto Alegre · NCT07264179 · Data updated 2026-11-12
This observational study looks at whether cuff pressure and other factors during surgery are linked to throat pain, hoarseness, cough, or minor bleeding after elective surgeries in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 362 (estimated) |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande Do Sul (RS)) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | April 30, 2029 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT07264179 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) undergoing elective surgery with general anesthesia and orotracheal intubation at the enrolling institution.
✕Probably not a fit
Patients with no risk factors or whose postoperative symptoms are unrelated to cuff pressure may see little to no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study will enroll adults undergoing elective procedures with general anesthesia and orotracheal intubation at Hospital de Clínicas de Porto Alegre. Researchers will collect data on cuff pressure, tube characteristics, and patient factors to identify risk factors for tracheal mucosal injuries and related postoperative symptoms. Multivariate analysis will be used to derive a risk score for predicting tracheal injuries, with outcomes assessed up to 30 days after surgery. The goal is to better understand how intraoperative cuff management relates to postoperative throat and airway symptoms. The study does not involve an intervention beyond observation and data collection.
Why it matters
Potential benefit: If successful, the risk score could help clinicians tailor cuff management and airway care to reduce tracheal injuries and postoperative throat symptoms.
How similar studies have gone: Previous work has linked cuff overinflation to tracheal injury and postoperative symptoms, but this study seeks to derive a specific risk score for better prediction.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande Do Sul (RS), Brazil Recruiting
Study contacts
- Principal investigator: Clovis Tadeu Bevilacqua Filho, MD, MSc. — Serviço de Anestesia e Medicina Perioperatória, HCPA.
- Study coordinator: Clovis Tadeu Bevilacqua Filho, MD, MSc.
- Email: clovisfilho@hcpa.edu.br
- Phone: +555198133-5024
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.