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Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Awake Extubation | Active Comparator | Removal of the endotracheal tube while the patient is no longer under general anesthesia |
|
| Deep Extubation | Active Comparator | Removal of the endotracheal tube while the patient is under general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extubation | Procedure | Removal of the endotracheal tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aggregate Rate of Airway and Respiratory Complications | Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration | Peri-extubation period |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Postoperative Sore Throat | Sore Throat Rated on 0-10 Visual Analog Scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40745279 | Derived | Lee MA, Schenke PW, Faller MR, DeYoung HR, Adams AR. A comparison of deep versus awake tracheal extubation in adults: a randomized controlled trial. BMC Anesthesiol. 2025 Jul 31;25(1):387. doi: 10.1186/s12871-025-03224-6. |
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| ID | Term |
|---|---|
| D060666 | Airway Extubation |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)
| 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) | Peri-extubation period |
| End-of-Surgery to Out-Of-Room Time | Duration in Minutes | 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 | From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes) |