Comparison of Deep Versus Awake Tracheal Extubation in Adults

Not Applicable

Completed

• Conditions: Airway Complication of Anesthesia; Respiratory Complications of Care

• 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

Study Timeline

• Study Start: 2020-08-28
• Study First Submitted: 2022-04-23
• Study First Submitted QC: 2022-04-30
• Study First Posted: 2022-05-05
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-26
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

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

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