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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

362 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-05

Study Completion Date

2029-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Tracheal Intubation Postoperative Complications (Cardiopulmonary)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Group - Elective Surgical Patients

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No