Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande Do Sul (RS), 90410-000, Brazil
Location status: Recruiting
NCT Number: NCT07264179
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Porto Alegre, Rio Grande Do Sul (RS), 90410-000, Brazil
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
Contact information is provided by the study sponsor or research team.
Hospital de Clinicas de Porto Alegre
Other
Tracheal Cuff Pressure and Postoperative Complications: Prospective Observational Study.
Acronym: TCP-POC
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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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