Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Mechanical ventilation (MV) is the most frequently used life-support modality in intensive care units (ICUs). To reduce anxiety, stress and promote tolerance of MV, nurses frequently administer a variety of sedative medications to their patients based on subjective observations.

The investigators hypothesize that patient-controlled sedation, compared to clinician-directed sedation, will decrease sedative exposure while decreasing patient anxiety during the episode of mechanical ventilation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer; National Institute of Nursing Research (NINR)
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• adult intubated patients with respiratory failure expected to require mechanical ventilation for at least an additional 48 hours

• subjects have to have at least a 50% chance of being able to operate the PCS machine (i.e., adequate hand strength and cognition)

Exclusion Criteria:

• aggressive ventilatory support such as positive end expiratory pressure > 15 cm of water, prone ventilation, use of high-frequency oscillator ventilator

• hypotension requiring vasopressors (systolic blood pressure < 85 mmHg), second or third degree heart block or bradycardia (heart rate < 50 beats/min.)

• permanent condition preventing the use of push button device (e.g., paralysis)

• pregnancy or lactation

• acute hepatitis or liver failure

• general anesthesia 24 hours prior

• acute stroke or uncontrolled seizures

• acute MI

• severe cognition or communication problems (e.g., coma as main reason for intubation, deafness without signing literacy, dementia or severe delirium)