Comparison of Deep Versus Awake Tracheal Extubation in Adults
Not Applicable
Completed
- Conditions
- Airway Complication of AnesthesiaRespiratory Complications of Care
- Interventions
- Procedure: Extubation
- Registration Number
- NCT05361850
- Lead Sponsor
- United States Navy
- Brief Summary
Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Awake Extubation Extubation Removal of the endotracheal tube while the patient is no longer under general anesthesia Deep Extubation Extubation Removal of the endotracheal tube while the patient is under general anesthesia
- Primary Outcome Measures
Name Time Method Aggregate Rate of Airway and Respiratory Complications Peri-extubation period Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration
- Secondary Outcome Measures
Name Time Method Peri-extubation Heart Rate Peri-extubation period Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)
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 Duration in Minutes
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) Incidence of Richmond Agitation-Sedation Scale score \>=2
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 Sore Throat Rated on 0-10 Visual Analog Scale
Peri-extubation Blood Pressure Peri-extubation period 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)
Trial Locations
- Locations (1)
Naval Medical Center Portsmouth
🇺🇸Portsmouth, Virginia, United States