By InvitationNot Applicable

Deflated and Inflated Cuff Endotracheal Extubations

United States88 participantsStarted 2025-06-17

Plain-language summary

General anesthesia is a treatment with medicine to make a patient unconscious for surgery. This is sometimes called "being put to sleep" or "being put under." Most of the time, a breathing tube is used to help a machine breathe for patients. The breathing tube has a cuff, which is like a small balloon. After the breathing tube is placed, the cuff is inflated. This keeps the breathing tube in place and keeps fluids like saliva and stomach juices from getting into the windpipe and lungs. When a breathing tube is removed, that is called extubation. Normally, doctors deflate the cuff before removing the breathing tube. This is called deflated cuff extubation. Some doctors worry that keeping the cuff inflated while it is removed can damage the throat or vocal cords. However, some doctors keep the cuff inflated when removing the breathing tube. This is called inflated cuff extubation. These doctors think that keeping the cuff inflated can help keep fluids from entering the airway. Doctors have not studied if deflated cuff extubation is better or worse than inflated cuff extubation. The goal of this study is to see which type of extubation is better at keeping fluids from getting in the airway. Participants who are part of this study will get general anesthesia and have surgery as planned. Near the end of surgery, a small amount of liquid is placed at the back of a participant's mouth. This liquid is called contrast material, and it is like a dye. The contrast material will help determine if any liquid enters the windpipe or lungs. Then, contrast material is removed, along with any other fluids, using normal methods. When it is safe to take the breathing tube out, a deflated cuff extubation or an inflated cuff extubation will be performed. This decision will be made at random, like by the flip of a coin. Information will be collected about participants, the surgery, and how well a participant is breathing. After surgery, a chest x-ray will be taken to see if any of the contrast material is in the windpipe or lungs. Otherwise, everything else after surgery would be normal. 24 to 48 hours after surgery, a member of the research team will ask about any symptoms a participant may have, like sore throat or a hoarse voice. Research would conclude at that time.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Airway Contamination

Timeframe: 0-30 minutes after arrival in the Post Anesthesia Care Unit

Trial details

NCT IDNCT06990308

SponsorNaval Medical Center Camp Lejeune

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-09