Acupuncture for Sedation in the Intensive Care Unit (ICU)

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture for Sedation in the Intensive Care Unit

Conditions
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Delirium, Respiratory Depression, Overmedication

Intervention / Treatment
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* Device: Verum Acupuncture
* Device: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum Acupuncture<br>Subjects will receive acupuncture using real acupuncture needles. | Device: Verum Acupuncture<br>* DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days<br>* Other names: Special No. 16 needles (Gauge 8 x 1.2);|
| Sham Comparator: Sham acupuncture<br>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. | Device: Sham Acupuncture<br>* DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days<br>* Other names: Streitberger Placebo-needles (Gauge 8 x 1.2);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Blinding | Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments. | Nurse 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Richmond Agitation-Sedation Scale (RAAS) Score | Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.' | Median RAAS score during treatment (5 days) | 
| Length of Ventilator Dependence | Number of hours of ventilator use | Number hourss subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiolytics, Sedatives, Acupuncture Therapy