Clinical trial NCT05361850: Comparison of Deep Versus Awake Tracheal Extubation in Adults
Official title: Comparison of Deep Versus Awake Tracheal Extubation in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Complication of Anesthesia
Respiratory Complications of Care
Keywords: Awake Extubation
Deep Extubation
Lead sponsor: United States Navy
Sponsor class: FED
First posted: 2022-05-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Aggregate Rate of Airway and Respiratory Complications
timeFrame: Peri-extubation period
Secondary outcomes:
measure: Incidence and Severity of Postoperative Sore Throat
timeFrame: At time of transfer from PACU Phase 1 to PACU Phase 2 once PACU Phase 1 discharge criteria met, minimum of twenty minutes
measure: Peri-extubation Heart Rate
timeFrame: Peri-extubation period
measure: Peri-extubation Blood Pressure
timeFrame: Peri-extubation period
measure: End-of-Surgery to Out-Of-Room Time
timeFrame: 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
measure: Peri-extubation Agitation
timeFrame: From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes)
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
References: