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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

Must not have

Significant neurological deficit due to a chronic disorder

Admission after resuscitation from cardiac arrest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am receiving continuous pain or sedation medication from the ICU team.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a long-term neurological condition that affects my daily activities.

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I was admitted to the hospital after being revived from a cardiac arrest.

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I was given continuous pain or sedation medication from another hospital.

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I am currently taking medication for muscle control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mechanical Ventilation days until successful extubation

Secondary study objectives

Duration of MV weaning

Other study objectives

Adverse Events related to Mechanical Ventilation

ICU length of stay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met