Airway Complication of AnesthesiaCDATENCT05361850
Comparison of Deep Versus Awake Tracheal Extubation in Adults
A study testing Extubation in people with Airway Complication of Anesthesia and Respiratory Complications of Care, run by United States Navy at 1 site in United States.
Trial summary
Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia, Respiratory Complications of Care
- What is being tested?
- Extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status classification system for assessing the fitness of patients before surgery 1-3
- Meeting American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting
- Adult patients age 18-64
- Favorable airway examinations (Mallampati 1 or 2, normal mouth opening, and intact neck extension)
- Scheduled cases in which tracheal intubation and general anesthesia are indicated
Who cannot join
- Patients with chronic obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
- Unfavorable airway examinations (Mallampati 3 or 4, limited mouth opening, and/or inability to extend neck)
- Full stomach
- Known difficult intubation or mask ventilation
- Surgeries of the airway and intrathoracic surgeries
- Emergent surgeries
Show all 14Show fewer
- Case duration >6 hours
- Pregnancy
- Patients scheduled to receive a protocolized anesthetic (Enhanced Recovery After Surgery aka ERAS)
- ASA Physical Status Classification 4 or 5
- Chronic diseases such as obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
- Uncontrolled gastroesophageal reflux disease (heartburn) defined by presence of symptoms despite compliance with appropriate medication regimen
- Patient scheduled to receive a protocolized anesthetic ie Enhanced Recovery After Anesthesia (ERAS)
- Surgeries requiring prone positioning
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
- Being tested
- Extubation
- Keywords
- Awake Extubation, Deep Extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExtubationProcedure or surgery
Removal of the endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Awake Extubation | Active comparator | Removal of the endotracheal tube while the patient is no longer under general anesthesia Receives: Procedure: Extubation |
| Deep Extubation | Active comparator | Removal of the endotracheal tube while the patient is under general anesthesia Receives: Procedure: Extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate Rate of Airway and Respiratory Complications
Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration
Measured: Peri-extubation period
Secondary outcomes (5)
Incidence and Severity of Postoperative Sore Throat
Sore Throat Rated on 0-10 Visual Analog Scale
Measured: At time of transfer from PACU Phase 1 to PACU Phase 2 once PACU Phase 1 discharge criteria met, minimum of twenty minutes
Peri-extubation Heart Rate
Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)
Measured: Peri-extubation period
Peri-extubation Blood Pressure
Systolic, Diastolic, and Mean Arterial Pressure in Millimeters of Mercury by Non-Invasive Blood Pressure, Incidence and Severity of Hypertension and Hypotension (defined as 20% from Baseline Blood Pressure)
Measured: Peri-extubation period
End-of-Surgery to Out-Of-Room Time
Duration in Minutes
Measured: From End-of-Surgery Time (defined by surgical dressing application) to Out-of-Room Time (defined by patient physically leaving operating room), up to two hours
Peri-extubation Agitation
Incidence of Richmond Agitation-Sedation Scale score >=2
Measured: From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start28 Aug 2020
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Navy
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael Andrew Lee, United States Navy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361850
- Sponsor's protocol ID
- NMCP.2020.0097
- Acronym
- CDATE
- Status last verified
- May 2023
- First submitted
- 23 Apr 2022
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee MA, Schenke PW, Faller MR, DeYoung HR, Adams AR. A comparison of deep versus awake tracheal extubation in adults: a randomized controlled trial. BMC Anesthesiol. 2025 Jul 31;25(1):387. doi: 10.1186/s12871-025-03224-6.
PubMed 40745279
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Deep Versus Awake Tracheal Extubation in Adults
- ClinicalTrials.gov ID
- NCT05361850
- Acronym / sponsor ID
- CDATE / NMCP.2020.0097
- Keywords
- Awake Extubation, Deep Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- United States NavyUS federal agency
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 5 May 2022 (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.
Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake Extubation | Active comparator | Procedure: ExtubationRemoval of the endotracheal tube while the patient is no longer under general anesthesia |
| Deep Extubation | Active comparator | Procedure: ExtubationRemoval of the endotracheal tube while the patient is under general anesthesia |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA physical status classification system for assessing the fitness of patients before surgery 1-3
- Meeting American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting
- Adult patients age 18-64
- Favorable airway examinations (Mallampati 1 or 2, normal mouth opening, and intact neck extension)
- Scheduled cases in which tracheal intubation and general anesthesia are indicated
Key exclusion criteria (14 listed)
- Patients with chronic obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
- Unfavorable airway examinations (Mallampati 3 or 4, limited mouth opening, and/or inability to extend neck)
- Full stomach
- Known difficult intubation or mask ventilation
- Surgeries of the airway and intrathoracic surgeries
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 |
|---|---|---|
| ExtubationRemoval of the endotracheal tube | Procedure or surgery | Awake Extubation, Deep Extubation |
Primary outcome
Aggregate Rate of Airway and Respiratory Complications
Time frame: Peri-extubation period
Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration
5 secondary outcomes
Incidence and Severity of Postoperative Sore Throat
Time frame: At time of transfer from PACU Phase 1 to PACU Phase 2 once PACU Phase 1 discharge criteria met, minimum of twenty minutes
Peri-extubation Heart Rate
Time frame: Peri-extubation period
Peri-extubation Blood Pressure
Time frame: Peri-extubation period
End-of-Surgery to Out-Of-Room Time
Time frame: From End-of-Surgery Time (defined by surgical dressing application) to Out-of-Room Time (defined by patient physically leaving operating room), up to two hours
Peri-extubation Agitation
Time frame: From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 40745279Lee MA, Schenke PW, Faller MR, DeYoung HR, Adams AR. A comparison of deep versus awake tracheal extubation in adults: a randomized controlled trial. BMC Anesthesiol. 2025 Jul 31;25(1):387. doi: 10.1186/s12871-025-03224-6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extubation in people with Airway Complication of Anesthesia and Respiratory Complications of Care, run by United States Navy 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 6 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Aggregate Rate of Airway and Respiratory Complications (time frame: Peri-extubation period). 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 NCT05361850, which also lists 1 linked publication.
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 6 May 2023.