Acupuncture for Sedation in the Intensive Care Unit (ICU)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Delirium Respiratory Depression Overmedication |
Device: Acupuncture Therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Acupuncture for Sedation in the Intensive Care Unit |
- Quantity of Sedation [ Time Frame: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. ] [ Designated as safety issue: No ]Quantity of sedation, anxiolytic and analgesic medications.
- RAAS Score [ Time Frame: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. ] [ Designated as safety issue: No ]Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'
- Pain Score [ Time Frame: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. ] [ Designated as safety issue: No ]Measure of pain. Scale of 0-10, with 0 equal to 'No pain' and 10 equal to 'Worst possible pain.'
- ICU Stay [ Time Frame: Number of days in ICU. ICU length of stay (ILOS) defined as time of arrival in ICU until transfer to ward. ILOS estimated to average two (2) weeks per subject. Assessed up to discharge (estimated 3 weeks). ] [ Designated as safety issue: No ]
- Length of ventilator dependence [ Time Frame: Number hours subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks). ] [ Designated as safety issue: No ]
- Success of blinding [ Time Frame: RN surveyed daily for length of study (five [5] days). Physician and subject (or subject's family if he/she is unable to complete the questionnaire) surveyed upon study completion, six (6) days after enrollment. ] [ Designated as safety issue: No ]Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2016 |
| Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Verum Acupuncture
Subjects will receive verum, or "real," acupuncture.
|
Device: Acupuncture Therapy
DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
Other Names:
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Sham Comparator: Sham acupuncture
Subjects will receive sham acupuncture therapy using the Streitberger needle at the same points and on the same schedule as patients in the treatment group. Streitberger needles are blunt tipped and retract into themselves rather than penetrating the skin.
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Device: Acupuncture Therapy
DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
Other Names:
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Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Trauma patient ≥ 18 years admitted to the Trauma ICU
- Injury Severity Score (ISS) ≥ 4
- Mechanically ventilated < 24 hours with anticipated need > 24 hours
Exclusion Criteria:
- Inability to obtain consent from patient or designee
- Receiving immunosuppressive therapy
- Receiving therapeutic anticoagulant therapy
- History of bleeding disorder, INR > 1.5, PTT > 65, PLT < 20K
- Pregnancy
- Three (3) or more inaccessible acupoints
- Head injury with elevated intracranial pressure or requiring operation
- Patients with midline abdominal incision
- Non-english speaking
- Receipt of dexmedetomidine prior to or during study period
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01362270
| United States, Oregon | |
| Oregon Health & Science University (OHSU) | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Jennifer M Watters, MD | Oregon Health and Science University |
More Information
Publications:
| Responsible Party: | Jennifer M Watters, Associate Professor of Surgery, Director Surgical Critical Care, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01362270 History of Changes |
| Other Study ID Numbers: | MRF 811 |
| Study First Received: | May 25, 2011 |
| Last Updated: | May 18, 2016 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Anxiolytics Sedatives Acupuncture Therapy |
Additional relevant MeSH terms:
|
Delirium Respiratory Insufficiency Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Neurocognitive Disorders Mental Disorders Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 28, 2016