NCT07264179

Tracheal Cuff Pressure and Postoperative Complications: A Prospective Observational Study.

Tracheal Cuff Pressure and Postoperative Complications: Prospective Observational Study.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 362 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Orotracheal tubes are widely used in medical practice to secure the airway and enable invasive mechanical ventilation. Modern tubes are made of medical-grade PVC with an inflatable cuff at the distal end to isolate the lower airway, prevent gas leaks from ventilation, and reduce contamination risks from upper airway secretions or gastric content. Although current cuffs are high-volume, low-pressure, overinflation complications are common, leading to variable severity lesions (isolated or confluent lesions, tracheal mucosal edema, erosions, or ulcerations with bleeding), and symptoms like dysphonia/aphonia (15-80%), cough, pain, and hemoptysis (10-15%). Overinflation can compromise tracheal mucosal perfusion, causing ischemia, necrosis, tracheoesophageal fistulas, or tracheal rupture, especially in patients requiring prolonged intubation. Even short exposures (hours) can cause significant lesions. Many physicians rely on manual palpation or experience to set cuff pressure, often inaccurately. This study will evaluate risk factors in elective surgical patients at HCPA, using multivariate regression to identify independent variables and derive a risk score.

Conditions

• Tracheal Intubation
• Postoperative Complications (Cardiopulmonary)

Timeline

• Start date: 2026-01-05
• Primary completion: 2028-07-31
• Completion: 2029-04-30
• First posted: 2025-12-04
• Last updated: 2025-12-04