Acupuncture for Sedation in the Intensive Care Unit (ICU)

Not Applicable

Completed

Conditions: Overmedication
Delirium
Respiratory Depression

Interventions: Device: Verum Acupuncture
Device: Sham Acupuncture

Registration Number: NCT01362270

Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum Acupuncture	Verum Acupuncture	Subjects will receive acupuncture using real acupuncture needles.
Sham acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Success of Blinding	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.	Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.

Secondary Outcome Measures

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