Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06259565 |
Other study ID # |
4257 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
October 2, 2024 |
Est. completion date |
January 2, 2025 |
Study information
Verified date |
April 2024 |
Source |
St. Joseph's Healthcare Hamilton |
Contact |
Kimberley Lewis, MD |
Phone |
(289)775-7334 |
Email |
kimberley.lewis[@]medportal.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Acute respiratory failure (ARF) is a common reason for admission to an intensive care unit
(ICU). Non-invasive positive pressure ventilation (NIV) is a life-saving intervention for
selected patients with ARF. Compared to endotracheal intubation and invasive mechanical
ventilation (IMV), NIV is safer, less invasive, preferred by most patients, and is associated
with a reduced ICU length of stay (LOS), less pneumonia and mortality, and lower healthcare
costs.
NIV failure can occur, necessitating IMV. Risk factors associated with NIV failure including
intolerance, agitation, and delirium. Sedation is a potential solution for NIV intolerance,
however the evidence is sparse and the risk of over-sedation resulting in respiratory
depression, inability to protect the airway, and inadvertent need for intubation are all
large deterrents.
Dexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in IMV that promotes
patient wakefulness, has no effect on respiratory drive, has important analgesic properties,
and reduces delirium. The investigators hypothesize that Dex, when compared to placebo,
reduces NIV failure in hospitalized adults with ARF and agitation or NIV intolerance.
Overall Goal: To determine if Dex, compared to placebo, reduces the risk of NIV failure in
patients that admitted to hospital with acute respiratory failure and are intolerant of NIV.
Target Population: 826 patients will be enrolled into the vanguard trial if they meet all the
following criteria: 1) ≥18 years old; 2) Receiving any NIV modality for ARF of any etiology;
3) Admitted to ICU, PACU, step-down unit (surgical or medical), or emergency department; 4)
Presence of one or more of the following: a) Agitation, b) Patient expresses intolerance or
requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia, or
c) Other reason that the physician feels the patient is intolerant of NIV or agitated, not
captured above.
Methods: The inDEX trial is a pragmatic, international, multi-centred, stratified,
randomized, parallel-group, placebo-controlled trial. Patients, investigators, healthcare
team, data collectors, outcome assessors, and the statistician will be blinded to trial arms.
The trial will maximize external validity by including patients in a range of hospitals
across the world. Patients randomized to the experimental arm will receive Dex while those
randomized to the control arm will receive placebo.
Assessment: The primary outcome is NIV failure. The investigators define NIV failure as the
proportion that require intubation or have died at 28 days.