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Dexmedetomidine for Respiratory Insufficiency (inDEX Trial)

Phase 3
Waitlist Available
Led By Kimberley Lewis, MD
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient receiving any NIV modality for acute respiratory failure of any etiology
Presence of agitation (Defined as a Richmond Agitation and Sedation Scale [RASS] score of ≥+2 or a Riker Sedation-Agitation Scale [SAS] score of ≥5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the completion of the trial (approximately 1 year).
Awards & highlights

inDEX Trial Summary

This trial is looking at whether or not dexmedetomidine, a sedative, can help improve a patient's tolerance of non-invasive ventilation (NIV), which is a life saving intervention for those with acute respiratory failure.

Who is the study for?
This trial is for adults over 18 in the ICU or similar units with acute respiratory failure who are agitated, intolerant to non-invasive ventilation due to discomfort, anxiety, or claustrophobia. It's not for those whose care plan excludes intubation, have post-extubation respiratory failure, are on dexmedetomidine already, withdrawing from substances, have persistent low blood pressure despite treatment, certain heart conditions without a pacemaker, known allergy to dexmedetomidine, pregnant women or those with acute liver failure.Check my eligibility
What is being tested?
The study tests if sedation with Dexmedetomidine can help patients better tolerate non-invasive ventilation and avoid needing invasive mechanical ventilation compared to a placebo. This could lead to adopting sedative use in such cases if proven effective and safe.See study design
What are the potential side effects?
Dexmedetomidine may cause side effects like over-sedation leading to breathing difficulties and potentially requiring intubation. Other risks include low blood pressure (hypotension), slow heart rate (bradycardia), dry mouth and nausea.

inDEX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently receiving non-invasive ventilation for breathing difficulties.
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I experience significant agitation.
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I am currently admitted to a critical care unit or emergency department.
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I am 18 years old or older.

inDEX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the completion of the trial (approximately 1 year).
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the completion of the trial (approximately 1 year). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Consent Rate
Protocol Adherence; Proportion of patients assigned to the experimental arm that received the intervention and those assigned to the control arm that did not receive the intervention.
Recruitment Rate
Secondary outcome measures
Acute care unit outcomes; Acute Care Unite Length of Stay
Acute care unit outcomes; Duration of invasive mechanical ventilation
Acute care unit outcomes; Non-invasive ventilation (NIV) failure
+17 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

inDEX Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dexmedetomidine InterventionExperimental Treatment1 Intervention
Patients randomized to the experimental arm will receive dexmedetomidine. At initiation, a bolus will NOT be administered. In keeping with Health Canada. Guidelines, the infusion will start at a mid-range dose of 0.6mcg/kg/h with titration either up or down by 0.1mcg/kg/h every 20-30 minutes to a maximum rate of 1.2mcg/kg/h to maintain light sedation (Richmond Agitation-Sedation Scale [RASS] = -2 to +1 or Riker Sedation-Agitation Scale [SAS] 3-4).
Group II: Control InterventionPlacebo Group1 Intervention
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 50mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~1980

Find a Location

Who is running the clinical trial?

Hamilton Academic Health Sciences OrganizationOTHER
20 Previous Clinical Trials
4,842 Total Patients Enrolled
2 Trials studying Respiratory Insufficiency
200 Patients Enrolled for Respiratory Insufficiency
St. Joseph's Healthcare HamiltonLead Sponsor
196 Previous Clinical Trials
25,520 Total Patients Enrolled
5 Trials studying Respiratory Insufficiency
906 Patients Enrolled for Respiratory Insufficiency
Kimberley Lewis, MDPrincipal InvestigatorResearch Institute of St Joseph's Healthcare Hamilton
3 Previous Clinical Trials
1,226 Total Patients Enrolled
2 Trials studying Respiratory Insufficiency
400 Patients Enrolled for Respiratory Insufficiency

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the fatality rate associated with Dexmedetomidine?

"There is some evidence to support the efficacy of Dexmedetomidine, as this is a Phase 3 trial. Furthermore, there is ample data suggesting that Dexmedetomidine is a safe medication. For these reasons, our team at Power has given Dexmedetomidine a safety rating of 3."

Answered by AI

What does this experiment aim to learn or prove?

"The primary outcome of this study is Protocol Adherence; Proportion of patients assigned to the experimental arm that received the intervention and those assigned to the control arm that did not receive the intervention. Secondary objectives include Adverse Events: hypertension which is defined as Adverse events will be defined as; hypertension (a systolic blood pressure >180mmHg or a diastolic blood pressure >110mmHg), Adverse Events: Cardiac Arrest which is defined as Adverse events will be defined as; cardiac arrest, and Adverse Events: clinically significant hypotension which is defined as Adverse events will be defined as"

Answered by AI

For what conditions is dexmedetomidine often prescribed?

"Various maladies such as disease, ventilations, mechanical, and cyclic vomiting syndrome can all be treated using Dexmedetomidine."

Answered by AI

Are there currently patients being enrolled in this trial?

"The trial, which was posted on March 7th, 2022 and updated on May 3rd, 2022, is currently looking for participants."

Answered by AI

To what extent has Dexmedetomidine been studied in other scientific trials?

"There are 119 different ongoing clinical trials testing Dexmedetomidine. Dexmedetomidine is currently being studied most extensively in Karachi, Sindh, where 25 of the 119 trials are taking place. However, there are a total of 221 different research sites for this medication."

Answered by AI

How many subjects will be included in this experiment?

"Yes, the trial is ongoing and recruiting patients. According to the information available on clinicaltrials.gov, the study was posted on 3/7/2022 and was last edited on 5/3/2022. They are looking for 100 participants at 1 location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Non-invasive Ventilation and Dex in Critically Ill Adults
Kimberley Lewis 2022. "Non-invasive Ventilation and Dex in Critically Ill Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04878510.
~8 spots leftby Apr 2025
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