Tracheal Cuff Pressure and Postoperative Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital de Clinicas de Porto Alegre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than 18 years.
Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
Disqualifiers
Age less than 18 years.
Refusal to participate in the study.
Surgeries performed on an urgent or emergency basis.
Surgeries in pregnant women.
Trial population
Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
362 Participants
are grouped into 1 trial groupGroup A: Single Group - Elective Surgical Patients
Trial outcomes
Primary outcomes
1
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-opSecondary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital de Clinicas de Porto Alegre
Lead sponsor
Federal University of Rio Grande do Sul
Collaborator
Source ClinicalTrials.gov