Phase 2
N=15
Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients
Acute Respiratory Failure · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT01606852 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Aggregate Sedative Exposure During PCS Use (up to 5 Days). — 4; 3.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexmedetomidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aggregate Sedative Exposure During PCS Use (up to 5 Days). |
4; 3.5 | — |
| SECONDARY Number of Participants With Adverse Events |
7; 8 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01606852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.