Airway Complication of Anesthesia, Respiratory Complications of Care
Conditions
Keywords
Awake Extubation, Deep Extubation
Brief summary
Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
Interventions
PROCEDUREExtubation
Removal of the endotracheal tube
Sponsors
United States Navy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aggregate Rate of Airway and Respiratory Complications | Peri-extubation period | Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Heart Rate | Peri-extubation period | Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate) |
| 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) |
| 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 |
Countries
United States
Outcome results
None listed