Your session is about to expire
← Back to Search
General Anesthetic
Sedatives for Emergency Intubation (RSI Trial)
Phase 4
Recruiting
Led By Jonathan D Casey, MD, MSc
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned procedure is orotracheal intubation using a laryngoscope
Patient is critically ill and undergoing emergency tracheal intubation with sedation in an enrolling unit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of procedure (minutes)
Awards & highlights
RSI Trial Summary
This trial is testing whether ketamine or etomidate is better for people who need emergency tracheal intubation and are critically ill.
Who is the study for?
This trial is for critically ill adults needing emergency tracheal intubation with sedation. Participants must be undergoing the procedure in a participating unit and not be prisoners, pregnant, allergic to the study drugs, under 18 years old, or have trauma as a primary diagnosis.Check my eligibility
What is being tested?
The trial is testing whether Ketamine or Etomidate is better for sedating critically ill adults during emergency tracheal intubation. It aims to see which drug leads to fewer cardiovascular complications and improves patient outcomes.See study design
What are the potential side effects?
Ketamine may cause changes in blood pressure, increased heart rate, hallucinations or confusion post-use. Etomidate can lead to low blood pressure and adrenal insufficiency but tends to have less impact on heart function.
RSI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a procedure to have a tube placed in my windpipe using a throat scope.
Select...
I am critically ill and need an emergency procedure to help me breathe.
RSI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause, 28-day, in-hospital mortality
Secondary outcome measures
Cardiovascular Collapse
Other outcome measures
Cardiac arrest receiving cardiopulmonary resuscitation between induction and hospital discharge
Cardiac arrest within 2 minutes of intubation not resulting in death within 1 hour of induction
Cardiac arrest within 2 minutes of intubation resulting in death within 1 hour of induction
+15 moreRSI Trial Design
2Treatment groups
Active Control
Group I: Ketamine GroupActive Control1 Intervention
Patients in the ketamine group will be assigned to receive intravenous ketamine for induction of anesthesia during tracheal intubation. A dose of 2 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of ketamine than recommended if felt to be required for optimal patient care.
Group II: Etomidate GroupActive Control1 Intervention
Patients in the etomidate group will be assigned to receive intravenous etomidate for induction of anesthesia during tracheal intubation. A dose of 0.3 mg/kg will be recommended, and the group assignment sheet will contain a nomogram providing the recommended dose for a range of patient weights (in pounds and kg). In this pragmatic trial, treating clinicians will be able elect to give a lesser or greater dose of etomidate than recommended if felt to be required for optimal patient care.
Find a Location
Who is running the clinical trial?
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,995,094 Total Patients Enrolled
1 Trials studying Acute Respiratory Failure
1,756 Patients Enrolled for Acute Respiratory Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,849,230 Total Patients Enrolled
9 Trials studying Acute Respiratory Failure
34,624 Patients Enrolled for Acute Respiratory Failure
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
669,829 Total Patients Enrolled
6 Trials studying Acute Respiratory Failure
7,401 Patients Enrolled for Acute Respiratory Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My procedure will be done by a clinician skilled in tracheal intubation.I do not require immediate breathing support through a tube.I am under 18 years old.I chose not to participate in the RSI trial.I am scheduled for a procedure to have a tube placed in my windpipe using a throat scope.My doctor thinks ketamine is necessary or should be avoided for my treatment.I am in the emergency room due to an injury.I am critically ill and need an emergency procedure to help me breathe.My doctor thinks etomidate is necessary or should be avoided for my treatment.My doctor recommends a specific medication for my treatment that is not ketamine or etomidate.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine Group
- Group 2: Etomidate Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining slots available for enrollment into this clinical trial?
"Affirmative. The details posted on clinicaltrials.gov inform us that this medical investigation is actively accepting participants, having been first published on April 6th 2022 and recently updated by August 4th of the same year. This experiment requires 1 test site to recruit a total of 1900 volunteers for participation."
Answered by AI
How many participants are actively engaging in this research endeavor?
"Affirmative. The clinicaltrials.gov website mentions that this trial, which was first shared on April 6th 2022, is currently enrolling participants. 1900 patients must be enrolled from one medical centre for the study to succeed."
Answered by AI
Has the FDA sanctioned Etomidate Group's products?
"There is ample clinical evidence that Etomidate Group poses a low safety risk, thus it achieved the maximum score of 3."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger