Acupuncture for Sedation in the Intensive Care Unit (ICU)

Overview

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.

Full Title of Study: “Acupuncture for Sedation in the Intensive Care Unit”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2015

Interventions

  • Device: Verum Acupuncture
    • DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
  • Device: Sham Acupuncture
    • DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Arms, Groups and Cohorts

  • Experimental: Verum Acupuncture
    • Subjects will receive acupuncture using real acupuncture needles.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Success of Blinding
    • Time Frame: 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 Measures

  • Richmond Agitation-Sedation Scale (RAAS) Score
    • Time Frame: Median RAAS score during treatment (5 days)
    • Measure of sedation. Scale -5 to +4, with -5 equal to ‘Unarousable’ and +4 equal to ‘Combative.’
  • Length of Ventilator Dependence
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Collaborator
    • Medical Research Foundation, Oregon
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jennifer M Watters, Associate Professor of Surgery, Director Surgical Critical Care – Oregon Health and Science University
  • Overall Official(s)
    • Jennifer M Watters, MD, Principal Investigator, Oregon Health and Science University

References

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.

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.

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.

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.

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.

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