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NCT01362270 · ClinicalTrials.gov registry record · NA
Acupuncture for Sedation in the Intensive Care Unit (ICU)
A NA study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT01362270 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 15 participants.
The verdict
NCT01362270, a NA study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is helping a patient breathe if he can't breathe on his own. Because of the mechanical ventilation, these patients also require some medication to help keep them calm. These are called sedatives or anxiolytics. The purpose of this study is to see if acupuncture can lower the amount of sedation and anxiolysis needed by a subject during mechanical ventilation in the TICU. Acupuncture is a medical procedure. Hair-thin sterile needles are inserted at specific points on the body. PROCEDURES Some subjects will get acupuncture and others will get 'fake' acupuncture. By using 'fake' acupuncture, no one other than the acupuncturists will know which group a subject is in. Subjects and the team do not get to pick which subject is in which group. Instead, the groups are picked randomly. Subjects will get real or fake acupuncture twice a day for five days. Standard of care - Both groups will receive the standard of care while in the study. They will be mechanically ventilated and given sedatives and analgesics based on the TICU protocol. Real acupuncture group - This group will receive real acupuncture with real needles. These are stainless steel, one time use, needles. This group will also receive "ear tacks" which are like little needles that can stay on the ear for a few days. The ear tacks will be covered with a bandage so no one can tell which group the subject is in. Sham acupuncture group - This group will receive sham needles. These needles retract into themselves much like a 'magic sword' rather than poking the skin. Subjects in this group will not get ear tacks. In order to hide the group the subject is in, a bandage will be used to cover part of the ear. HYPOTHESIS Real acupuncture will decrease subject's sedation requirements by 30% when compared to the sham acupuncture group.
Interventions
- DEVICE Sham Acupuncture
- DEVICE Verum Acupuncture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01362270
The ClinicalTrials.gov registry entry for NCT01362270 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham Acupuncture is the first listed.
NCT01362270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01362270 about?
NCT01362270 is a clinical study titled "Acupuncture for Sedation in the Intensive Care Unit (ICU)". BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is helping a patient breathe if he can't breathe on his own. Because of the mechanical ventilation, these patients also require som...
What is the current status of trial NCT01362270?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2011-07. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01362270?
The interventions under investigation include: Sham Acupuncture (DEVICE), Verum Acupuncture (DEVICE).
Who is sponsoring clinical trial NCT01362270?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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