Deflated and Inflated Cuff Endotracheal Extubations

Launched by NAVAL MEDICAL CENTER CAMP LEJEUNE · May 17, 2025

Keywords

ClinConnect Summary

This study is comparing two ways to remove a breathing tube after general anesthesia: deflating the cuff before removal versus leaving the cuff inflated during removal. It’s a randomized, parallel-group trial at Naval Medical Center Camp Lejeune where participants and those collecting results are blinded to which method you receive. The researchers want to know which method is better at keeping liquids from getting into the windpipe and lungs right after extubation. To test this, a small amount of contrast dye is placed in the back of the throat during anesthesia, and a chest X-ray after extubation checks if any dye has entered the airway. They’ll also track short-term breathing problems and throat or voice symptoms in the first 6 minutes after extubation and again 24–48 hours later.

Adults aged 18–50 who are healthy enough for planned, non-airway surgery lasting less than 3 hours (ASA I–III) may be eligible. Exclusions include emergency surgery, known lung or throat disease, pregnancy, allergy to the contrast dye iohexol, a difficult airway, and other conditions that might affect anesthesia. About 88 participants are planned (44 per group). If you qualify and join, you’ll be randomly assigned to either inflated cuff extubation or deflated cuff extubation, while follow-up care remains standard. The study will collect safety and outcome data and plans to share de-identified data with researchers in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 18 to 50 years old
• • Scheduled for surgery, not of the airway, head, or neck, with anticipated case duration of less than 3 hours
• • American Society of Anesthesiologists (ASA) Physical Status Classification of 1 to 3
• Exclusion Criteria:
• • Emergent surgery, or surgery requiring prone, sitting or lateral positioning
• • Pre-existing laryngeal pathology, obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infection, recent pneumonia, uncontrolled asthma, or uncontrolled gastroesophageal reflux disease
• • Known difficulties with general anesthesia, such as prior anaphylactic reaction, difficult intubation or mask ventilation
• • Known allergy to iohexol or a previous severe reaction to any contrast agents
• • Unfavorable airway examination, such as Mallampati 4, limited mouth opening, and/or inability to extend neck
• • Non-compliance with ASA Practice Guidelines for Preoperative Fasting
• • Pregnancy
• • Enrollment in another anesthesiology or surgery related interventional research study
• • Surgeries scheduled on Friday or a day immediately prior to a holiday