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Analgesia-First Sedation for Respiratory Failure
N/A
Recruiting
Research Sponsored by MemorialCare Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Initiated continuous sedative/analgesic infusions by the ICU team
≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial will compare two approaches to sedation and pain management for trauma patients needing mechanical ventilation.
Who is the study for?
This trial is for adults over 18 who are on mechanical ventilation due to trauma, expected to need it for at least 48 hours, and can potentially be weaned off. It's not suitable for those with chronic neurological issues, allergies to certain sedatives, a history of substance abuse, prior continuous sedation from another hospital or those on muscle relaxants.Check my eligibility
What is being tested?
The study compares two methods of managing pain and sedation in mechanically ventilated trauma patients: the usual method with daily wake-up checks versus an 'analgesia-first' strategy that prioritizes pain management and minimizes sedative use.See study design
What are the potential side effects?
Potential side effects may include discomfort due to less frequent use of sedatives under the analgesia-first approach. However, specific side effects will depend on individual reactions to pain medications and any used sedatives.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving continuous pain or sedation medication from the ICU team.
Select...
I am 18 years old or older.
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
Mechanical Ventilation days until successful extubation
Secondary outcome measures
Duration of MV weaning
Other outcome measures
Adverse Events related to Mechanical Ventilation
ICU length of stay
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Analgesia First SedationExperimental Treatment1 Intervention
Subjects will be randomized to receive analgesia-first sedation by intermittent doses of Fentanyl (25 mcg), instead of continuous IV infusions. If the intermittent IVP x4 fails to achieve the target pain score, an infusion starts at 50 mcg/hr and titration by 25 mcg q15 minutes. If sedation score is not achieved, propofol infusion starts at 5 mcg/kg/min to achieve goal RASS of 0 to -2. Subjects will be assessed for a ventilator weaning trial daily.
Group II: Protocol Directed Sedation and Daily Sedation InterruptionActive Control1 Intervention
Subjects will receive Fentanyl for analgesia and midazolam for sedation management. The RASS score is used to guide sedation to a goal of 0 to -2 and daily sedation by IV Midazolam at 1 mg/hr and titrated by 1 mg/hr q60 mins. Midazolam boluses are allowed by 1 mg IVP q5 mins x2 before increasing the infusion rate. Propofol and dexmedetomidine are permitted under existing institutional sedation protocol. Fentanyl IV starts at 50 mcg/hr and is titrated by 25 mcg/hr q15 mins to achieve target pain score. Fentanyl bolus of 25 mcg IVP q5 min x2 doses is given before increasing the infusion rate. Daily sedation interruption (DSI) is performed daily and ventilator weaning trial if they pass.
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Who is running the clinical trial?
MemorialCare Health SystemLead Sponsor
20 Previous Clinical Trials
2,385 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using a breathing machine and are expected to continue using it for at least 48 hours.I have a long-term neurological condition that affects my daily activities.You are allergic to midazolam, lorazepam, or propofol.I was admitted to the hospital after being revived from a cardiac arrest.I am considered for weaning off mechanical ventilation.I am receiving continuous pain or sedation medication from the ICU team.You have a history of being dependent on alcohol or using illegal drugs.I am 18 years old or older.I was given continuous pain or sedation medication from another hospital.I am currently taking medication for muscle control.
Research Study Groups:
This trial has the following groups:- Group 1: Analgesia First Sedation
- Group 2: Protocol Directed Sedation and Daily Sedation Interruption
Awards:
This trial has 1 awards, including:- 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 available vacancies in this medical trial for participants?
"According to clinicaltrials.gov, this particular trial is not currently recruiting participants; The study was first posted March 1st 2023 and the latest update occurred on February 28th of the same year. Nonetheless, 206 other studies are actively searching for suitable candidates at present."
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