Deflated and Inflated Cuff Endotracheal Extubations

NCT06990308 | Enrolling By Invitation DMC

• 1 other identifier: NMCCL.2025.0007
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia Airway Management; Respiratory Complications

Keywords

General Endotracheal Anesthesia; Deflated Cuff Extubation; Inflated Cuff Extubation; Microaspiration; Airway Contamination

Outcome Measures

Primary Outcomes (1)

• 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)

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

Secondary Outcomes (12)

• Hypoxemia

  0 to 6 minutes after tracheal extubation

• Need for Supplemental Oxygen

  0-6 minutes after tracheal extubation

• Cough

  0 to 6 minutes after tracheal extubation

• Obstruction

  0 to 6 minutes after tracheal extubation

• Stridor

  0 to 6 minutes after tracheal extubation

Study Arms (2)

Inflated Cuff Arm: 44

EXPERIMENTAL

Extubation with an inflated endotracheal tube cuff

Procedure: Inflated Cuff Extubation

Deflated Cuff Arm: 44

ACTIVE COMPARATOR

Extubation with a deflated endotracheal tube cuff

Procedure: Deflated Cuff Extubation

Interventions

Inflated Cuff Extubation PROCEDURE

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.

Inflated Cuff Arm: 44

Deflated Cuff Extubation PROCEDURE

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.

Deflated Cuff Arm: 44

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naval Medical Center Camp Lejeune: lead

Study Sites (1)

Naval Medical Center Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, 28547, United States

Location

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Study Officials

• Michael A Lee, MD

  Naval Medical Center Camp Lejeune

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 25, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study protocol, SAP, ICF will be available beginning 24APR2025 indefinitely, de-identified individual participant data will be available approximately SEP2026-SEP2033
• Access Criteria: Medical and research professionals by request

Locations

US (1)