Clinical trial NCT01362270: Acupuncture for Sedation in the Intensive Care Unit (ICU)
Official title: Acupuncture for Sedation in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Respiratory Depression
Overmedication
Keywords: Anxiolytics
Sedatives
Acupuncture Therapy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Medical Research Foundation, Oregon
First posted: 2011-05-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Success of Blinding
timeFrame: 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 outcomes:
measure: Richmond Agitation-Sedation Scale (RAAS) Score
timeFrame: Median RAAS score during treatment (5 days)
measure: Length of Ventilator Dependence
timeFrame: Number hourss subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks).
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jennifer M Watters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greif R, Laciny S, Mokhtarani M, Doufas AG, Bakhshandeh M, Dorfer L, Sessler DI. Transcutaneous electrical stimulation of an auricular acupuncture point decreases anesthetic requirement. Anesthesiology. 2002 Feb;96(2):306-12. doi: 10.1097/00000542-200202000-00014.
citation: Wang SM, Kain ZN. Auricular acupuncture: a potential treatment for anxiety. Anesth Analg. 2001 Feb;92(2):548-53. doi: 10.1097/00000539-200102000-00049.
citation: Nayak S, Wenstone R, Jones A, Nolan J, Strong A, Carson J. Surface electrostimulation of acupuncture points for sedation of critically ill patients in the intensive care unit--a pilot study. Acupunct Med. 2008 Mar;26(1):1-7. doi: 10.1136/aim.26.1.1.
citation: McManus CA, Schnyer RN, Kong J, Nguyen LT, Hyun Nam B, Goldman R, Stason WB, Kaptchuk TJ. Sham acupuncture devices--practical advice for researchers. Acupunct Med. 2007 Jun;25(1-2):36-40. doi: 10.1136/aim.25.1-2.36.
citation: Shapiro MB, West MA, Nathens AB, Harbrecht BG, Moore FA, Bankey PE, Freeman B, Johnson JL, McKinley BA, Minei JP, Moore EE, Maier RV; Inflammation and the Host Response to Injury Large Scale Collaborative Research Project. V. Guidelines for sedation and analgesia during mechanical ventilation general overview. J Trauma. 2007 Oct;63(4):945-50. doi: 10.1097/TA.0b013e318142d21b. No abstract available.