Comparison of Deep Versus Awake Tracheal Extubation in Adults

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Deep Versus Awake Tracheal Extubation in Adults

Conditions
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Airway Complication of Anesthesia, Respiratory Complications of Care

Intervention / Treatment
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* Procedure: Extubation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Awake Extubation<br>Removal of the endotracheal tube while the patient is no longer under general anesthesia | Procedure: Extubation<br>* Removal of the endotracheal tube<br>|
| Active Comparator: Deep Extubation<br>Removal of the endotracheal tube while the patient is under general anesthesia | Procedure: Extubation<br>* Removal of the endotracheal tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Rate of Airway and Respiratory Complications | Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration | Peri-extubation period | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Awake Extubation, Deep Extubation