An observational study in Tracheal Intubation and Postoperative Complications (Cardiopulmonary), sponsored by Hospital de Clinicas de Porto Alegre. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Hospital de Clinicas de Porto Alegre · Observational
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.
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 362 is above the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
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Exclusion Criteria:
Single Group - Elective Surgical Patients (All patients undergoing elective surgeries with general anesthesia and orotracheal intubation; no arms as it is observational).
Presence of Tracheal Injury Symptoms (Composite Outcome).
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: First 24 hours post-op to 30 days post-op
Independent Variables for Tracheal Complications.
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).
Time frame: Intraoperative and up to 30 days post-op.
Plan to share: No — Individual participant data will not be shared with other researchers in its complete form. However, an anonymized database with partially included data can be shared with others if requested and for scientific purposes (including editorial requests). The data collected will be stored in REDCap and archived securely in an appropriate location, and will not be used for any purpose other than the objectives proposed by the project. All participants in the study will sign a term of commitment for the use of institutional data.
Started Jan 2026 (actual). Primary completion is estimated for Jul 2028, 30 months after the start.
Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 30 months is above that.
Counting every sponsor, half of 281 studies reached it within 23 months; a quarter within 10 and three quarters within 39.
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