Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients
Completed · Phase 1/Phase 2
Conditions studied: Acute Respiratory Failure, Anxiety
In brief
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.
Key facts
- Study ID
- NCT01606852
- Run by
- University of Minnesota
- People needed
- 15
- Starts
- 2013-03-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2018-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- University of Minnesota Medical Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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