Trial Outcomes & Findings for Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation (NCT NCT00871624)

Results Overview

NIV tolerance (NIV intolerance score =1 out of 4) A score of 1 for a comfortable and relaxed patient tolerating NIV; a score of 2 for mild intolerance with some discomfort and occasionally grabbing at the NIV mask; a score of 3 for moderate intolerance and discomfort with the NIV mask most of the time but more frequent grabbing at the mask, sometimes pulling it off; and a score of 4 for severe NIV intolerance with agitation and the inability to leave the NIV mask in place. The outcome measure description of the time frame is reported as the average of the NIV tolerance scores reported at the various time frames (0min, 30min, 60 min, 3hr, 6hr, 12hr, and then every 12hr after the start of NIV therapy up to 72 hours)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours

Results posted on

2017-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.	Placebo Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
Overall Study STARTED	18	18
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine n=18 Participants Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.	Placebo n=18 Participants Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.	Total n=36 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 6 • n=5 Participants	62 years STANDARD_DEVIATION 17 • n=7 Participants	65 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours

NIV tolerance (NIV intolerance score =1 out of 4) A score of 1 for a comfortable and relaxed patient tolerating NIV; a score of 2 for mild intolerance with some discomfort and occasionally grabbing at the NIV mask; a score of 3 for moderate intolerance and discomfort with the NIV mask most of the time but more frequent grabbing at the mask, sometimes pulling it off; and a score of 4 for severe NIV intolerance with agitation and the inability to leave the NIV mask in place. The outcome measure description of the time frame is reported as the average of the NIV tolerance scores reported at the various time frames (0min, 30min, 60 min, 3hr, 6hr, 12hr, and then every 12hr after the start of NIV therapy up to 72 hours)

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=16 Participants Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.	Placebo n=17 Participants Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
Tolerability of NIV as Assessed by an NIV Tolerance Score	99 percentage of time spent tolerant to NIV Interval 61.0 to 100.0	67 percentage of time spent tolerant to NIV Interval 40.0 to 100.0

SECONDARY outcome

Timeframe: Completed at baseline and every 4 hours after the start of NPPV therapy for the duration of the study

Percentage of time spent at desired sedation goal

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=16 Participants Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.	Placebo n=17 Participants Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive	100 percentage of time Interval 86.0 to 100.0	100 percentage of time Interval 100.0 to 100.0

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Russel Roberts, PharmD

Tufts Medical Center

Phone: 617-636-4576

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place