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

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.

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Key information

Conditions

Tracheal Intubation Cough Hemoptysis Hemorrhage Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Complications (Cardiopulmonary) Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Presence of Tracheal Injury Symptoms (Composite Outcome).

Time frame: First 24 hours post-op to 30 days post-op

Composite of hoarseness, pharyngolaryngeal pain, cough, and hemoptysis related to orotracheal tube use during surgery. Hoarseness, pain, and cough assessed via verbal numerical scale (0 = absent, 10 = worst possible). Hemoptysis assessed as present/absent, and volume (>100 ml/24h considered massive).

Secondary outcomes

Independent Variables for Tracheal Complications.

Time frame: Intraoperative and up to 30 days post-op.

Identification of independent variables (e.g., sex, age, tube duration, tube diameter, intubation attempts, unanticipated difficult airway, surgical table position, vasopressor use, comorbidities like hypertension, myocardial infarction, diabetes, peripheral arterial disease).

Study contacts

Contact information is provided by the study sponsor or research team.

Clovis Tadeu Bevilacqua Filho, MD, MSc.

CONTACT

[email protected]

+555198133-5024

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

Federal University of Rio Grande do Sul

Registry information

Official study title

Tracheal Cuff Pressure and Postoperative Complications: Prospective Observational Study.

Acronym: TCP-POC

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Dec 4, 2025
Registry last updated: Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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