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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Dexmedetomidine

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