Status:
COMPLETED
Comparison of Deep Versus Awake Tracheal Extubation in Adults
Lead Sponsor:
United States Navy
Conditions:
Airway Complication of Anesthesia
Respiratory Complications of Care
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05361850
Start Date
August 28 2020
End Date
April 26 2023
Last Update
May 6 2023
Active Locations (1)
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1
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708