Deflated and Inflated Cuff Endotracheal Extubations (DICEE)

December 8, 2025 updated by: Michael Lee, Naval Medical Center Camp Lejeune

A Single-center, Patient- and Assessor-blinded, Randomized Controlled Trial to Compare Patient Outcomes Between Deflated and Inflated Cuff Endotracheal Extubations During Scheduled, Non-airway Surgery in Healthy Adults

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Marine Corps Base Camp Lejeune, North Carolina, United States, 28547
        • Naval Medical Center Camp Lejeune

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inflated Cuff Arm: 44
Extubation with an inflated endotracheal tube cuff
Procedure: Inflated 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.
Active Comparator: Deflated Cuff Arm: 44
Extubation with a deflated endotracheal tube cuff
Procedure: Deflated Cuff Extubation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway Contamination
Time Frame: 0-30 minutes after arrival in the Post Anesthesia Care Unit
Number of patients with presence of radio-opaque contrast material at or below the level of the carina on portable chest radiograph (yes/no)
0-30 minutes after arrival in the Post Anesthesia Care Unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoxemia
Time Frame: 0 to 6 minutes after tracheal extubation

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
0 to 6 minutes after tracheal extubation
Need for Supplemental Oxygen
Time Frame: 0-6 minutes after tracheal extubation
Arterial Desaturation to <95% SpO2 requiring oxygen supplementation Yes/No Time (in seconds)
0-6 minutes after tracheal extubation
Cough
Time Frame: 0 to 6 minutes after tracheal extubation
5-point Modified Minogue Scale (0-4)
0 to 6 minutes after tracheal extubation
Obstruction
Time Frame: 0 to 6 minutes after tracheal extubation
Yes/No
0 to 6 minutes after tracheal extubation
Stridor
Time Frame: 0 to 6 minutes after tracheal extubation
Yes/No
0 to 6 minutes after tracheal extubation
Bronchospasm
Time Frame: 0 to 6 minutes after tracheal extubation
Yes/No
0 to 6 minutes after tracheal extubation
Laryngospasm
Time Frame: 0 to 6 minutes after tracheal extubation
Yes/No
0 to 6 minutes after tracheal extubation
Aspiration
Time Frame: 0 to 6 minutes after tracheal extubation
Yes/No
0 to 6 minutes after tracheal extubation
Sore Throat
Time Frame: 24-48 hours postoperatively
4-point Likert Scale, 0-3
24-48 hours postoperatively
Cough
Time Frame: 24-48 hours postoperatively
4-point Simplified Cough Score, 0-3
24-48 hours postoperatively
Voice Quality
Time Frame: 24-48 hours postoperatively
GRBAS scale: Grade (0-3), Roughness (0-3), Breathiness (0-3), Aesthenia (0-3), Strain (0-3)
24-48 hours postoperatively
Dysphagia
Time Frame: 24-48 hours postoperatively
4-point Bazaz Dysphagia Score (0-3)
24-48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naval Medical Center Camp Lejeune

Investigators

  • Principal Investigator: Michael A Lee, MD, Naval Medical Center Camp Lejeune

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 8, 2025

First Submitted That Met QC Criteria

May 17, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NMCCL.2025.0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All de-identified participant data

IPD Sharing Time Frame

Study protocol, SAP, ICF will be available beginning 24APR2025 indefinitely, de-identified individual participant data will be available approximately SEP2026-SEP2033

IPD Sharing Access Criteria

Medical and research professionals by request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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