INtubation With Sedation Only to Preserve Independent Respiratory Effort Trial

NCT07845305 | Enrolling By Invitation DMC

• 2 other identifiers: 251840K23HL181100
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Failure

Keywords

critical illness; emergency airway management; tracheal intubation; neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypoxemia

  Primary Effectiveness Outcome: Incidence of hypoxemia (SpO2 \<88%) during the interval between induction and 2 minutes after tracheal intubation

  During the interval between induction and 2 minutes after tracheal intubation

Secondary Outcomes (1)

• Incidence of Successful intubation on the first attempt

  Duration of placement of the endotracheal tube, an average duration of 4 minutes

Other Outcomes (23)

• Cormack-Lehane grade of glottic view

  Duration of placement of the endotracheal tube, an average duration of 4 minutes

• Time from induction to successful tracheal intubation

  Duration of placement of the endotracheal tube, an average duration of 4 minutes.

• Operator-assessed difficulty of intubation

  Duration of placement of the endotracheal tube, an average duration of 4 minutes.

Study Arms (2)

Sedation Only Group

ACTIVE COMPARATOR

Other: Intubation with a sedative medication only

Sedation Plus Neuromuscular Blockade Group

ACTIVE COMPARATOR

Other: Intubation with a sedative medication and neuromuscular blockade agent

Interventions

Intubation with a sedative medication only OTHER

Patients in the sedation only group will undergo emergency tracheal intubation with sedation only (without receiving neuromuscular blockade) on the first attempt. The choice and dose of the sedative agent(s) (e.g., etomidate, ketamine, propofol, or other) will will be at the discretion of the operator and in accordance with usual clinical practice in the participating unit.

Sedation Only Group

Intubation with a sedative medication and neuromuscular blockade agent OTHER

Patients in the sedation plus neuromuscular blockade group will receive sedation plus neuromuscular blockade prior to the first attempt at intubation. The choice and dose of the sedative agent(s)) (e.g., etomidate, ketamine, propofol, or other) and neuromuscular blockade agent(s) (e.g., succinylcholine, rocuronium, or other) will be at the discretion of the operator and in accordance with usual clinical practice in the participating unit.

Sedation Plus Neuromuscular Blockade Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is undergoing emergency tracheal intubation with the use of sedation in a participating unit
• Clinician willing to use a video-laryngoscope for the intubation

You may not qualify if:

• Patient is known to be less than 18 years old
• Patient is known to be pregnant
• Patient is known to be a prisoner
• Clinician has determined that use of a direct laryngoscope, bronchoscope, or an intubating laryngeal mask airway is required for the optimal care of the patient.
• Patient or Legally Authorized Representative declines participation during pre-enrollment conversation or by wearing opt-out bracelet for the INSPIRE trial
• Clinician has determined that a neuromuscular blocking agent is required or contraindicated for the optimal care of the patient
• Immediate need for tracheal intubation precludes safe performance of study procedures

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Intubation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Stephanie C DeMasi, MD, MS

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Jonathan D. Casey, MD, MSc

  Vanderbilt University Medical Center

  STUDY DIRECTOR

• Matthew W. Semler, MD, MSc

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Parallel group, pragmatic, randomized clinical trial

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 28, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): May 29, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)