Comparison of Deep Versus Awake Tracheal Extubation in Adults

Airway Complication of Anesthesia Clinical Trial

— CDATE  

Official title:

Comparison of Deep Versus Awake Tracheal Extubation in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05361850
• Other study ID #: NMCP.2020.0097
• Status: Completed
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: April 26, 2023

Study information

• Verified date: May 2023
• Source: United States Navy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Respiratory Complications of Care

Intervention

Procedure:
• Extubation
Removal of the endotracheal tube

Locations

Country	Name	City	State
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Navy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aggregate Rate of Airway and Respiratory Complications	Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration	Peri-extubation period
Secondary	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
Secondary	Peri-extubation Heart Rate	Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)	Peri-extubation period
Secondary	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
Secondary	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
Secondary	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)