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

NCT07264179 | Not Yet Recruiting

• 1 other identifier: 92008125.9.0000.5327
• Study Type: observational
• Target: 362
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Complications (Cardiopulmonary); Tracheal Intubation

Keywords

Tracheal cuff pressure; Tracheal mucosal lesions; Cough; Orotracheal tube; Postoperative hoarseness; Pharyngolaryngeal pain; Hemoptysis

Outcome Measures

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).

  First 24 hours post-op to 30 days post-op

Secondary Outcomes (1)

• Independent Variables for Tracheal Complications.

  Intraoperative and up to 30 days post-op.

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age greater than 18 years.
• Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Related Publications (3)

• 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.

  PMID: 24404708 RESULT

• 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.

  PMID: 20736432 RESULT

• 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.

  PMID: 33196479 RESULT

MeSH Terms

Conditions

Postoperative Complications; Cough; Hemoptysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Lung Diseases; Hemorrhage

Study Officials

• Clovis Tadeu Bevilacqua Filho, MD, MSc.

  Serviço de Anestesia e Medicina Perioperatória, HCPA.

  PRINCIPAL INVESTIGATOR

• Andre P Schmidt, MD, PhD

  Serviço de Anestesia e Medicina Perioperatória, HCPA.

  STUDY CHAIR

Central Study Contacts

Clovis Tadeu Bevilacqua Filho, MD, MSc.

CONTACT

+555198133-5024; clovisfilho@hcpa.edu.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share