Status:
COMPLETED
Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation
Lead Sponsor:
Tufts Medical Center
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 sta...
Detailed Description
Non-invasive positive-pressure ventilation (NPPV) is increasingly being used to manage patients with acute respiratory failure (ARF) in an effort to avoid the numerous negative sequelae associated wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00871624
Start Date
March 1 2009
End Date
February 1 2013
Last Update
December 18 2017
Active Locations (2)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Winchester Hospital
Winchester, Massachusetts, United States, 01890