CLINICAL TRIAL

Treatment for Airway Complication of Anesthesia

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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
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
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- 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)
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
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 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
Peri-extubation Heart Rate
PERI-EXTUBATION PERIOD
Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)
Aggregate Rate of Airway and Respiratory Complications
PERI-EXTUBATION PERIOD
Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration

Who is running the study

Principal Investigator
M. A. L.
Michael Andrew Lee, Staff Anesthesiologist
United States Navy

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Airway Complication of Anesthesia by sharing your contact details with the study coordinator.