Comparison of Deep Versus Awake Tracheal Extubation in Adults (CDATE)

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

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia; Respiratory Complications of Care
• Intervention / Treatment: Procedure: Extubation

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Awake Extubation; Removal of the endotracheal tube while the patient is no longer under general anesthesia	Procedure: Extubation; Removal of the endotracheal tube
Active Comparator: Deep Extubation; Removal of the endotracheal tube while the patient is under general anesthesia	Procedure: Extubation; Removal of the endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggregate Rate of Airway and Respiratory Complications	Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration	Peri-extubation period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Postoperative Sore Throat	Sore Throat Rated on 0-10 Visual Analog Scale	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)	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)	Peri-extubation period
End-of-Surgery to Out-Of-Room Time	Duration in Minutes	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	From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes)

Collaborators and Investigators

• Sponsor: United States Navy

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Awake Extubation; Deep Extubation
• Other Study ID Numbers: NMCP.2020.0097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No