Sedation Methods for Emergency Intubation

(INSPIRE Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The INtubation with Sedation Only to Preserve Independent Respiratory Effort (INSPIRE) trial is a pragmatic, non-blinded, parallel-group, randomized clinical trial comparing the effect of intubation with sedation only (intervention group) versus intubation with sedation plus neuromuscular blockade (control group) among adults undergoing emergency tracheal intubation in the ED and ICU with regard to the outcomes of: (1) hypoxemia during intubation, (2) successful intubation on the first attempt, and (3) awake immobility and PTSD symptoms. Patients who are determined by treating clinicians to require emergency tracheal intubation and who meet eligibility criteria will be enrolled and randomly assigned to either intubation with sedation only or intubation with sedation plus neuromuscular blockade.

Who Is on the Research Team?

SC

Stephanie C DeMasi, MD, MS

Principal Investigator

Vanderbilt University Medical Center

JD

Jonathan D. Casey, MD, MSc

Principal Investigator

Vanderbilt University Medical Center

MW

Matthew W. Semler, MD, MSc

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults in the emergency department or ICU who need urgent breathing tube placement (intubation) due to severe breathing problems or metabolic acidosis. Patients are included if their doctors decide they require emergency intubation and meet other basic eligibility criteria.

Inclusion Criteria

Clinician willing to use a video-laryngoscope for the intubation
I am having an emergency breathing tube placed with sedation in this hospital.

Exclusion Criteria

I have chosen not to participate in the trial.
I do not need a breathing tube right now.
My doctor says I need or cannot have a muscle relaxant for my care.
See 4 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two ways of performing emergency intubation: one group gets only sedative medication, while the other receives both a sedative and a muscle-paralyzing drug. Participants are randomly assigned to either approach.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Sedation Only GroupActive Control1 Intervention
Group II: Sedation Plus Neuromuscular Blockade GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+