An interventional study of Inflated Cuff Extubation and Deflated Cuff Extubation in Anesthesia Airway Management and Respiratory Complications, sponsored by Naval Medical Center Camp Lejeune. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Naval Medical Center Camp Lejeune · Not applicable, Interventional, and Treatment
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.
The current standard anesthetic practice for extubation is to deflate the endotracheal tube cuff using a syringe prior to extubation. While commonplace and nearly universally accepted, this practice is not based on evidence from randomized controlled trials but is instead due to concern for laryngeal or vocal cord injury and arytenoid cartilage dislocation. However, no publications exist in the medical literature that attribute laryngeal trauma directly to inflated cuff endotracheal tube extubation, as opposed to the process of extubation in general. To the contrary, case reports that describe peri operative extubation with unintentionally inflated cuffs all note the absence of negative outcome.
Alternatively, extubation with an inflated endotracheal tube cuff has been advocated as a technique to reduce airway complications in human and veterinary medicine. Tracheal aspiration, even micro-aspiration by oropharyngeal secretions, may increase the risk of pneumonia and other pulmonary complications. Based on an animal model, inflated cuff extubation may reduce airway contamination by oropharyngeal fluid. Additionally, leaving the endotracheal tube cuff inflated may effectively generate a vital capacity breath during extubation, maximizing oxygen reserves and facilitating a secretion-clearing cough. These theorized advantages may prolong the time to which supplemental oxygen is required as well as decrease airway/respiratory complications in the immediate post-extubation period. Within the intensive care setting, unplanned extubation (including accidental extubation and self-extubation) occurs at a rate of 3% to 16% of intubated patients or 0.1 to 3.6 per 100 days of mechanical ventilation. Estimates of national hospitalizations requiring mechanical ventilation approach 800,000, thereby placing the estimated number of unplanned extubations between 24,000 and 128,000. Presumably, the majority of these unplanned extubations are with inflated cuffs, and yet still no epidemic of laryngeal trauma from inflated cuff extubation exists. Furthermore, there have been no significant differences in laryngeal complications reported between planned and unplanned extubation in the intensive care population, suggesting that it is the endotracheal tube itself (and the process of placing it) that confers the risk of laryngeal complications, rather than the circumstances of its removal.
Though several providers have published their success with inflated cuff extubation, to date no prospective, randomized controlled trial has been performed directly comparing these two techniques. This study proposes to evaluate the effect of inflated cuff extubation on airway contamination by oropharyngeal material, extubation quality, post-extubation oxygenation, and laryngeal symptoms compared to the standard technique of deflated cuff extubation.
To assess the difference in aspiration rates between deflated and inflated cuff extubation, radio-opaque contrast material will be introduced into the oropharynx of intubated patients while under general anesthesia. The presence of this radio-opaque contrast at or below the level of the carina will be assessed with a chest radiograph taken postoperatively.
Naval Medical Center Camp Lejeune is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Extubation with an inflated endotracheal tube cuff
Procedure: Inflated Cuff Extubation
Extubation with a deflated endotracheal tube cuff
Procedure: Deflated Cuff Extubation
The adjustable pressure limiting valve will be set to 20 centimeters water pressure. To blind the Anesthesiologist Associate Investigator from the patient's group allocation, sham deflation of the endotracheal tube cuff pilot balloon will be performed with a 10 milliliter syringe. The endotracheal tube will be withdrawn into an opaque blue towel while the reservoir bag is simultaneously compressed to generate at least 20 centimeters water pressure positive airway pressure. In the rare event significant resistance is met with attempted extubation, the principal investigator will deflate the cuff in one milliliter increments until extubation is possible. This process does not unblind the Anesthesiologist Associate Investigator.
The adjustable pressure-limiting valve will be set to 20 centimeters water pressure. All air will be removed from the endotracheal tube cuff pilot balloon with a 10 milliliter syringe. The endotracheal tube will be withdrawn into an opaque blue towel, to prevent the Anesthesiologist Associate Investigator from identifying the patient's allocation, while the reservoir bag is simultaneously compressed to generate at least 20 centimeters water pressure positive airway pressure.
Airway Contamination
Number of patients with presence of radio-opaque contrast material at or below the level of the carina on portable chest radiograph (yes/no)
Time frame: 0-30 minutes after arrival in the Post Anesthesia Care Unit
Hypoxemia
Yes/No as defined by Arterial Saturation Pulse Oximeter (SpO2) reading of \<95% None Spo2 ≥ 95% Mild Spo2 91% - 94% Moderate Spo2 86% - 90% Severe Spo2 80% - 85% Critical Spo2 ≤ 79% Lowest SpO2 reading will be recorded
Time frame: 0 to 6 minutes after tracheal extubation
Need for Supplemental Oxygen
Arterial Desaturation to \<95% SpO2 requiring oxygen supplementation Yes/No Time (in seconds)
Time frame: 0-6 minutes after tracheal extubation
Cough
5-point Modified Minogue Scale (0-4)
Time frame: 0 to 6 minutes after tracheal extubation
Obstruction
Yes/No
Time frame: 0 to 6 minutes after tracheal extubation
Stridor
Yes/No
Time frame: 0 to 6 minutes after tracheal extubation
Bronchospasm
Yes/No
Time frame: 0 to 6 minutes after tracheal extubation
Laryngospasm
Yes/No
Time frame: 0 to 6 minutes after tracheal extubation
Aspiration
Yes/No
Time frame: 0 to 6 minutes after tracheal extubation
Sore Throat
4-point Likert Scale, 0-3
Time frame: 24-48 hours postoperatively
Cough
4-point Simplified Cough Score, 0-3
Time frame: 24-48 hours postoperatively
Voice Quality
GRBAS scale: Grade (0-3), Roughness (0-3), Breathiness (0-3), Aesthenia (0-3), Strain (0-3)
Time frame: 24-48 hours postoperatively
Dysphagia
4-point Bazaz Dysphagia Score (0-3)
Time frame: 24-48 hours postoperatively
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All de-identified participant data
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Naval Medical Center Camp Lejeune