EnrollingByInvitation · 18 - 65 · All Sexes · Portsmouth, VA
Comparison of Deep Versus Awake Tracheal Extubation in Adults
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About the trial for Airway Complication of Anesthesia
Eligible Conditions
Airway Complication of Anesthesia · Respiratory Complications of Care
Treatment Groups
This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Control Group 1
Extubation
PROCEDURE
Control Group 2
Extubation
PROCEDURE
Eligibility
This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.
Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have a physical status of ASA 1, 2, or 3.show original
Meeting American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting
You are an adult aged 18 to 64 years.show original
You have a medical condition that makes you likely to need tracheal intubation and general anesthesia.show original
You have a favorable airway examination.show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Peri-extubation period
Screening: ~3 weeks
Treatment: Varies
Reporting: Peri-extubation period
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Peri-extubation period.
View detailed reporting requirements
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like
Measurement Requirements
This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Airway Complication of Anesthesia. Measurement will happen over the course of Peri-extubation period.
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)
PERI-EXTUBATION PERIOD
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
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
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
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 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
FROM TEN MINUTES PRIOR TO EXTUBATION TO TRANSFER TIME FROM PACU PHASE 1 TO PACU PHASE 2 (MINIMUM PACU PHASE 1 STAY 20 MINUTES)
Peri-extubation Heart Rate
PERI-EXTUBATION PERIOD
Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)
PERI-EXTUBATION PERIOD
Aggregate Rate of Airway and Respiratory Complications