Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

ConditionNon-Invasive Ventilation

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorSt. Joseph's Healthcare Hamilton

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Patient receiving any NIV modality for acute respiratory failure of any etiology

Admitted to ICU, PACU, step-down unit (surgical or medical), or emergency department(with planned admission to a monitored setting) or equivalent unit where hemodynamics and respiratory status can be monitored, and NIV is permitted; and

Agitation (Defined as a Richmond Agitation and Sedation Scale [RASS] score of ≥+2 or a Riker Sedation-Agitation Scale [SAS] score of ≥5) (Appendix 1 Table 2 and Table 3)

Disqualifiers

Absence of a functioning pacemaker with one of the following: a-Persistent bradycardia defined as a heart rate (HR) ≤60bpm; b-Second or third-degree heart block; or c- Tachybrady syndrome

Persistent hypotension, defined as a mean arterial pressure (MAP) ≤65mmHg despite volume resuscitation and vasopressors

Imminent need for endotracheal intubation as determined by healthcare team

Patient's goals of care do not include intubation and IMV

Trial design

Design model

Parallel

Treatments tested in this trial

Dexmedetomidine
Drug
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
Placebo Control
Other 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 100mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans

Treatment groups

846 Participants

are divided into 2 treatment groups

Group A: Dexmedetomidine InterventionExperimental treatment 1 intervention

Group B: Placebo ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

NIV Failure

The primary outcome is NIV failure, defined by either mortality or intubation

Time frame

28 days

Secondary outcomes

Physiologic outcomes: Incidence of delirium

Delirium assessed using the ICU-CAM or ICDSC every 12 hours during NIV and daily thereafter until ICU discharge

Time frame

28 days

Physiologic outcomes: Incidence of agitation

Agitation defined as Richmond Agitation Sedation Scale (RASS) ≥2+ during NIV), where RASS scale ranges from -5 (unrousable) to +4 (combative).

Time frame

28 days

Major morbidity or mortality outcomes: Intubation

Intubation

Time frame

14 days

Major morbidity or mortality outcomes: ICU Mortality

ICU mortality

Time frame

28 days

Other outcomes

Functional Outcome: EQ-5D-5L

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state

Time frame

90 days

Functional Outcome: EQ-VAS

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. EQ VAS scores range from 0 to 100, where 100 is the best possible health state.

Time frame

90 days

Functional Outcome: Clinical Frailty Scale

The CFS summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a clinician. A score from 1 (very fit) to 9 (terminally ill) is given based on the descriptions and pictographs of activity and functional status.

Time frame

90 days

Hospital outcomes

Hospital Length of Stay (LOS)

Time frame

90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Joseph's Healthcare Hamilton

Lead sponsor

Population Health Research Institute

Collaborator

Source ClinicalTrials.gov

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