Tracheal Cuff Pressure and Postoperative Complications: A Prospective Observational Study. (TCP-POC)

Tracheal Cuff Pressure and Postoperative Complications: 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tracheal Intubation; Postoperative Complications (Cardiopulmonary)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 362

Contacts and Locations

• Study Contact: Name: Clovis Tadeu Bevilacqua Filho, MD, MSc.; Phone Number: +555198133-5024; Email: clovisfilho@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	First 24 hours post-op to 30 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Intraoperative and up to 30 days post-op.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
• Investigators: Principal Investigator: Clovis Tadeu Bevilacqua Filho, MD, MSc., Serviço de Anestesia e Medicina Perioperatória, HCPA.; Study Chair: Andre P Schmidt, MD, PhD, Serviço de Anestesia e Medicina Perioperatória, HCPA.

Publications and helpful links

General Publications

• Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24.
• Grant T. Do current methods for endotracheal tube cuff inflation create pressures above the recommended range? A review of the evidence. J Perioper Pract. 2013 Dec;23(12):292-5. doi: 10.1177/175045891302301205.
• Brodsky MB, Akst LM, Jedlanek E, Pandian V, Blackford B, Price C, Cole G, Mendez-Tellez PA, Hillel AT, Best SR, Levy MJ. Laryngeal Injury and Upper Airway Symptoms After Endotracheal Intubation During Surgery: A Systematic Review and Meta-analysis. Anesth Analg. 2021 Apr 1;132(4):1023-1032. doi: 10.1213/ANE.0000000000005276.

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cough; Hemoptysis; Tracheal cuff pressure; Tracheal mucosal lesions; Orotracheal tube; Postoperative hoarseness; Pharyngolaryngeal pain
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cough; Postoperative Complications; Hemoptysis
• Other Study ID Numbers: 92008125.9.0000.5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No