Anesthesia Airway ManagementDICEENCT06990308
Deflated and Inflated Cuff Endotracheal Extubations
A study testing Inflated Cuff Extubation and Deflated Cuff Extubation in people with Anesthesia Airway Management and Respiratory Complications, run by Naval Medical Center Camp Lejeune at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Airway Management, Respiratory Complications
- What is being tested?
- Inflated Cuff Extubation and Deflated Cuff Extubation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Enrollment in another anesthesiology or surgery related interventional research study
- Surgeries scheduled on Friday or a day immediately prior to a holiday
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Naval Medical Center Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, 28547
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Inflated Cuff Extubation, Deflated Cuff Extubation
- Keywords
- General Endotracheal Anesthesia, Deflated Cuff Extubation, Inflated Cuff Extubation, Microaspiration, Airway Contamination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflated Cuff ExtubationProcedure or surgery
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.
Deflated Cuff ExtubationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Inflated Cuff Arm: 44 | Experimental | Extubation with an inflated endotracheal tube cuff Receives: Procedure: Inflated Cuff Extubation |
| Deflated Cuff Arm: 44 | Active comparator | Extubation with a deflated endotracheal tube cuff Receives: Procedure: Deflated Cuff Extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0-30 minutes after arrival in the Post Anesthesia Care Unit
Secondary outcomes (12)
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
Measured: 0 to 6 minutes after tracheal extubation
Need for Supplemental Oxygen
Arterial Desaturation to <95% SpO2 requiring oxygen supplementation Yes/No Time (in seconds)
Measured: 0-6 minutes after tracheal extubation
Cough
5-point Modified Minogue Scale (0-4)
Measured: 0 to 6 minutes after tracheal extubation
Obstruction
Yes/No
Measured: 0 to 6 minutes after tracheal extubation
Stridor
Yes/No
Measured: 0 to 6 minutes after tracheal extubation
Bronchospasm
Yes/No
Measured: 0 to 6 minutes after tracheal extubation
Laryngospasm
Yes/No
Measured: 0 to 6 minutes after tracheal extubation
Aspiration
Yes/No
Measured: 0 to 6 minutes after tracheal extubation
Sore Throat
4-point Likert Scale, 0-3
Measured: 24-48 hours postoperatively
Cough
4-point Simplified Cough Score, 0-3
Measured: 24-48 hours postoperatively
Voice Quality
GRBAS scale: Grade (0-3), Roughness (0-3), Breathiness (0-3), Aesthenia (0-3), Strain (0-3)
Measured: 24-48 hours postoperatively
Dysphagia
4-point Bazaz Dysphagia Score (0-3)
Measured: 24-48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start17 Jun 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naval Medical Center Camp Lejeune
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael Lee, Naval Medical Center Camp Lejeune
- Investigators
- Michael A Lee, MD, Principal investigator, Naval Medical Center Camp Lejeune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990308
- Sponsor's protocol ID
- NMCCL.2025.0007
- Acronym
- DICEE
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified participant data
Publications
Lin EC. Radiation risk from medical imaging. Mayo Clin Proc. 2010 Dec;85(12):1142-6; quiz 1146. doi: 10.4065/mcp.2010.0260.
PubMed 21123642Lasser EC, Lyon SG, Berry CC. Reports on contrast media reactions: analysis of data from reports to the U.S. Food and Drug Administration. Radiology. 1997 Jun;203(3):605-10. doi: 10.1148/radiology.203.3.9169676.
PubMed 9169676Caro JJ, Trindade E, McGregor M. The risks of death and of severe nonfatal reactions with high- vs low-osmolality contrast media: a meta-analysis. AJR Am J Roentgenol. 1991 Apr;156(4):825-32. doi: 10.2214/ajr.156.4.1825900.
PubMed 1825900Wolf GL, Arenson RL, Cross AP. A prospective trial of ionic vs nonionic contrast agents in routine clinical practice: comparison of adverse effects. AJR Am J Roentgenol. 1989 May;152(5):939-44. doi: 10.2214/ajr.152.5.939.
PubMed 2495706Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107.
PubMed 2343107Molfenter SM, Amin MR, Balou M, Herzberg EG, Frempong-Boadu A. A scoping review of the methods used to capture dysphagia after anterior cervical discectomy and fusion: the need for a paradigm shift. Eur Spine J. 2023 Mar;32(3):969-976. doi: 10.1007/s00586-022-07515-1. Epub 2023 Jan 10.
PubMed 36625955De Bodt MS, Wuyts FL, Van de Heyning PH, Croux C. Test-retest study of the GRBAS scale: influence of experience and professional background on perceptual rating of voice quality. J Voice. 1997 Mar;11(1):74-80. doi: 10.1016/s0892-1997(97)80026-4.
PubMed 9075179Ghio A, Revis J, Smithson-Barriere D, Jarze S, Giovanni A. Reliability and Correlations Between Overall Severity, Roughness and Breathiness in the Perception of Dysphonic Voices: Investigating Cognitive Aspects. J Voice. 2024 Jan;38(1):136-143. doi: 10.1016/j.jvoice.2021.07.010. Epub 2021 Aug 25.
PubMed 34452778Tung A, Fergusson NA, Ng N, Hu V, Dormuth C, Griesdale DGE. Pharmacological methods for reducing coughing on emergence from elective surgery after general anesthesia with endotracheal intubation: protocol for a systematic review of common medications and network meta-analysis. Syst Rev. 2019 Jan 24;8(1):32. doi: 10.1186/s13643-019-0947-2.
PubMed 30678727Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52.
PubMed 15385385Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
PubMed 12435974Dejonckere PH, Wieneke GH. GRBAS-scaling of pathological voices: reliability, clinical relevance and differentiated correlation with acoustic measurements, especially with central measurements. Proceedings of the 22nd IALP Congress. Hannover, Germany: 1992.
Hirano M. Clinical examination of voice. New York: Springer Verlag, 1981:81-4.
Lin R, Zhu L, Pan X. Validation of the simplified cough symptom score in non-small cell lung cancer patients after surgery. Gen Thorac Cardiovasc Surg. 2022 Aug;70(8):735-739. doi: 10.1007/s11748-022-01791-w. Epub 2022 Feb 28.
PubMed 35224703Lai K. Chinese National Guidelines on Diagnosis and Management of Cough: consensus and controversy. J Thorac Dis. 2014 Oct;6(Suppl 7):S683-8. doi: 10.3978/j.issn.2072-1439.2014.10.06. No abstract available.
PubMed 25383201
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06990308
- Acronym / sponsor ID
- DICEE / NMCCL.2025.0007
- Keywords
- General Endotracheal Anesthesia, Deflated Cuff Extubation, Inflated Cuff Extubation, Microaspiration, Airway Contamination
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Naval Medical Center Camp LejeuneUS federal agency
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflated Cuff Arm: 44 | Experimental | Procedure: Inflated Cuff ExtubationExtubation with an inflated endotracheal tube cuff |
| Deflated Cuff Arm: 44 | Active comparator | Procedure: Deflated Cuff ExtubationExtubation with a deflated endotracheal tube cuff |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflated Cuff ExtubationThe 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. | Procedure or surgery | Inflated Cuff Arm: 44 |
| Deflated Cuff ExtubationThe 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. | Procedure or surgery | Deflated Cuff Arm: 44 |
Primary outcome
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)
12 secondary outcomes
Hypoxemia
Time frame: 0 to 6 minutes after tracheal extubation
Need for Supplemental Oxygen
Time frame: 0-6 minutes after tracheal extubation
Cough
Time frame: 0 to 6 minutes after tracheal extubation
Obstruction
Time frame: 0 to 6 minutes after tracheal extubation
Stridor
Time frame: 0 to 6 minutes after tracheal extubation
Bronchospasm
Time frame: 0 to 6 minutes after tracheal extubation
Laryngospasm
Time frame: 0 to 6 minutes after tracheal extubation
Aspiration
Time frame: 0 to 6 minutes after tracheal extubation
Sore Throat
Time frame: 24-48 hours postoperatively
Cough
Time frame: 24-48 hours postoperatively
Voice Quality
Time frame: 24-48 hours postoperatively
Dysphagia
Time frame: 24-48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 21123642Lin EC. Radiation risk from medical imaging. Mayo Clin Proc. 2010 Dec;85(12):1142-6; quiz 1146. doi: 10.4065/mcp.2010.0260.
- Background: PubMed 9169676Lasser EC, Lyon SG, Berry CC. Reports on contrast media reactions: analysis of data from reports to the U.S. Food and Drug Administration. Radiology. 1997 Jun;203(3):605-10. doi: 10.1148/radiology.203.3.9169676.
- Background: PubMed 1825900Caro JJ, Trindade E, McGregor M. The risks of death and of severe nonfatal reactions with high- vs low-osmolality contrast media: a meta-analysis. AJR Am J Roentgenol. 1991 Apr;156(4):825-32. doi: 10.2214/ajr.156.4.1825900.
- Background: PubMed 2495706Wolf GL, Arenson RL, Cross AP. A prospective trial of ionic vs nonionic contrast agents in routine clinical practice: comparison of adverse effects. AJR Am J Roentgenol. 1989 May;152(5):939-44. doi: 10.2214/ajr.152.5.939.
- Background: PubMed 2343107Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107.
- Background: PubMed 36625955Molfenter SM, Amin MR, Balou M, Herzberg EG, Frempong-Boadu A. A scoping review of the methods used to capture dysphagia after anterior cervical discectomy and fusion: the need for a paradigm shift. Eur Spine J. 2023 Mar;32(3):969-976. doi: 10.1007/s00586-022-07515-1. Epub 2023 Jan 10.
- Background: PubMed 9075179De Bodt MS, Wuyts FL, Van de Heyning PH, Croux C. Test-retest study of the GRBAS scale: influence of experience and professional background on perceptual rating of voice quality. J Voice. 1997 Mar;11(1):74-80. doi: 10.1016/s0892-1997(97)80026-4.
- Background: PubMed 34452778Ghio A, Revis J, Smithson-Barriere D, Jarze S, Giovanni A. Reliability and Correlations Between Overall Severity, Roughness and Breathiness in the Perception of Dysphonic Voices: Investigating Cognitive Aspects. J Voice. 2024 Jan;38(1):136-143. doi: 10.1016/j.jvoice.2021.07.010. Epub 2021 Aug 25.
- Background: PubMed 30678727Tung A, Fergusson NA, Ng N, Hu V, Dormuth C, Griesdale DGE. Pharmacological methods for reducing coughing on emergence from elective surgery after general anesthesia with endotracheal intubation: protocol for a systematic review of common medications and network meta-analysis. Syst Rev. 2019 Jan 24;8(1):32. doi: 10.1186/s13643-019-0947-2.
- Background: PubMed 15385385Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52.
- Background: PubMed 12435974Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
- BackgroundDejonckere PH, Wieneke GH. GRBAS-scaling of pathological voices: reliability, clinical relevance and differentiated correlation with acoustic measurements, especially with central measurements. Proceedings of the 22nd IALP Congress. Hannover, Germany: 1992.
- Individual participant dataSharing planned: Yes. All de-identified participant data
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Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress
Anesthesia, General, Airway Management
Not yet recruiting
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
Airway Management
Recruiting
Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery
Tracheal Intubation, Videolaryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael A Lee, MD principal investigator
Naval Medical Center Camp Lejeune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflated Cuff Extubation and Deflated Cuff Extubation in people with Anesthesia Airway Management and Respiratory Complications, run by Naval Medical Center Camp Lejeune at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway Contamination (time frame: 0-30 minutes after arrival in the Post Anesthesia Care Unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06990308, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.