Phase 2
N=36
Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation
Acute Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT00871624 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Tolerability of NIV as Assessed by an NIV Tolerance Score — 99; 67 percentage of time spent tolerant to NIV — p=0.54
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexmedetomidine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability of NIV as Assessed by an NIV Tolerance Score |
99; 67 | 0.54 |
| SECONDARY Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive |
100; 100 | 0.3 |
Summary
The purpose of the study is to determine the efficacy and safety of dexmedetomidine during Non-invasive positive pressure ventilation (NPPV) for patients with acute respiratory failure compared to standard analgesic/sedation practices
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Acute respiratory failure requiring the initiation of NPPV
- Admission to the medical ICU service at Tufts Medical Center or Winchester Hospital
Exclusion Criteria
- Patients with delirium (intensive care delirium screening checklist score ≥ 4) or disorientation (not oriented to person or place)
- Receiving NPPV for ≥ 8 hours (includes treatment with NPPV at an outside hospital)
- Intubation and mechanical ventilation in the past month based on hospital admission note
- Age ≥ 85 years
- Inability of the potential subject to give informed consent
- Current treatment with antipsychotic agent based on hospital admission note
- Heart rate ≤ 50 bpm
- Systolic blood pressure ≤ 90 mmHg
- History of heart block without pacemaker use or severe ventricular dysfunction (EF ≤25%) based on hospital admission note
- Acute alcohol withdrawal based on hospital admission note
- History of end stage liver failure (based on presence of ≥ 1 or more of the following: AST/ALT ≥ 2 times ULN, INR ≥ 2, total bilirubin ≥ 1.5
- Irreversible brain disease consistent with severe dementia based on hospital admission note
- Pregnancy (all women of child-bearing age will undergo a pregnancy test prior to study enrollment)
- Treatment with clonidine or dexmedetomidine in the past 30 days based on hospital admission note
- Known allergy or sensitivity to clonidine or dexmedetomidine
Data sourced from ClinicalTrials.gov (NCT00871624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.