Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients
NCT01606852
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- 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)
- 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)
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- Minneapolis, Minnesota
Descriptive Information | ||||
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Brief Title ICMJE | Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients | |||
Official Title ICMJE | Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients | |||
Brief 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. | |||
Detailed Description | A study to determine whether critically ill patients, during a substantial portion of their time on mechanical ventilation, can reduce anxiety symptoms better with PCS than their caregivers while reducing over-sedation, duration of mechanical ventilation and length of ICU stay will require hundreds of subjects enrolled on a multi-day protocol. However, patient-controlled sedation has been used in less than 20 patients and only for less than 24 hours. Therefore this study is designed to:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: Dexmedetomidine
loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days. Other Name: Administered via a Lifecare PCA Infusion System (Hospira) | |||
Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 15 | |||
Original Estimated Enrollment ICMJE | 40 | |||
Actual Study Completion Date ICMJE | July 2015 | |||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01606852 | |||
Other Study ID Numbers ICMJE | IND 111693 R21NR012795 ( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Minnesota | |||
Study Sponsor ICMJE | University of Minnesota | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Minnesota | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |