Tracheal Cuff Pressure and Postoperative Complications: A Prospective Observational Study. (TCP-POC)

Hospital de Clinicas de Porto Alegre

Status: Not yet enrolling

Conditions: Tracheal Intubation; Postoperative Complications (Cardiopulmonary)

Study type: Observational

Funder types: Other

Identifiers

NCT07264179

92008125.9.0000.5327

Details and patient eligibility

About

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.

Full 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.

Enrollment: 362 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

362 participants in 1 patient group

Single Group - Elective Surgical Patients

Description:

Single Group - Elective Surgical Patients (All patients undergoing elective surgeries with general anesthesia and orotracheal intubation; no arms as it is observational).