NCT05361850

Brief Summary

Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

April 23, 2022

Last Update Submit

May 3, 2023

Conditions

Airway Complication of AnesthesiaRespiratory Complications of Care

Keywords

Awake ExtubationDeep Extubation

Outcome Measures

Primary Outcomes (1)

  • Aggregate Rate of Airway and Respiratory Complications

    Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration

    Peri-extubation period

Secondary Outcomes (5)

  • Incidence and Severity of Postoperative Sore Throat

    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

    Peri-extubation period

  • Peri-extubation Blood Pressure

    Peri-extubation period

  • End-of-Surgery to Out-Of-Room Time

    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

    From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes)

Study Arms (2)

Awake Extubation

ACTIVE COMPARATOR

Removal of the endotracheal tube while the patient is no longer under general anesthesia

Procedure: Extubation

Deep Extubation

ACTIVE COMPARATOR

Removal of the endotracheal tube while the patient is under general anesthesia

Procedure: Extubation

Interventions

ExtubationPROCEDURE

Removal of the endotracheal tube

Awake ExtubationDeep Extubation

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Related Publications (1)

  • 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.

    PMID: 40745279DERIVED

MeSH Terms

Interventions

Airway Extubation

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

April 23, 2022

First Posted

May 5, 2022

Study Start

August 28, 2020

Primary Completion

April 26, 2023

Study Completion

April 26, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)