Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Removal of the endotracheal tube
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
Aggregate Rate of Airway and Respiratory Complications
Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration
Time frame: Peri-extubation period
Incidence and Severity of Postoperative Sore Throat
Sore Throat Rated on 0-10 Visual Analog Scale
Time frame: At time of transfer from PACU Phase 1 to PACU Phase 2 once PACU Phase 1 discharge criteria met, minimum of twenty minutes
Peri-extubation Heart Rate
Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)
Time frame: Peri-extubation period
Peri-extubation Blood Pressure
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)
Time frame: Peri-extubation period
End-of-Surgery to Out-Of-Room Time
Duration in Minutes
Time frame: 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
Peri-extubation Agitation
Incidence of Richmond Agitation-Sedation Scale score \>=2
Time frame: From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes)
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