Acupuncture for Sedation in the Intensive Care Unit (ICU)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-07-31

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.

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Detailed Description

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Conditions

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Delirium Respiratory Depression Overmedication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum Acupuncture

Subjects will receive acupuncture using real acupuncture needles.

Group Type EXPERIMENTAL

Verum Acupuncture

Intervention Type DEVICE

DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

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.

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type DEVICE

DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Interventions

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Verum Acupuncture

DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Intervention Type DEVICE

Sham Acupuncture

DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Intervention Type DEVICE

Other Intervention Names

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Special No. 16 needles (Gauge 8 x 1.2") Streitberger Placebo-needles (Gauge 8 x 1.2")

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No