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Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

NCT06259565 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 846

Last updated 2025-09-10

No results posted yet for this study

Summary

Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV.

The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure.

Conditions

  • Non-Invasive Ventilation

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in invasive mechanical ventilation (IMV) that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium

OTHER

Placebo Control

Those in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. Each bag of placebo contains 100mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Kimberley Lewis, MD · St. Joseph's Healthcare Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-29
Primary Completion
2029-12-31
Completion
2030-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259565 on ClinicalTrials.gov