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

United States Navy

Status: Completed

Conditions: Respiratory Complications of Care; Airway Complication of Anesthesia

Treatments: Procedure: Extubation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05361850

NMCP.2020.0097

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Awake Extubation

Active Comparator group

Description:

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

Treatment:

Procedure: Extubation

Deep Extubation

Active Comparator group

Description:

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

Treatment:

Procedure: Extubation