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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Failure

In brief

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

Key facts

Study ID

NCT00871624

Run by

Tufts Medical Center

People needed

36

Starts

2009-03-01

Expected to finish

2013-02-01

Last updated by the study team

2017-12-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Acute respiratory failure requiring the initiation of NPPV
• Admission to the medical ICU service at Tufts Medical Center or Winchester Hospital

You may not qualify if…

• 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

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States
• Winchester Hospital — Winchester, Massachusetts, United States

Full record on ClinicalTrials.gov

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