Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06259565
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-12-27
Brief Title:
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults An International Pragmatic Randomized Controlled Trial inDEX Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
inDEX
Brief 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 patients 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None