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| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
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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 ClÃnicas 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clovis Tadeu Bevilacqua Filho, MD, MSc. | Contact | +555198133-5024 | clovisfilho@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24404708 | Result | 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. | |
| 20736432 | 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. |
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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.
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D003371 | Cough |
| D006469 | Hemoptysis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 33196479 | 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. |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D008171 | Lung Diseases |
| D006470 | Hemorrhage |