Acupuncture for Sedation in the Intensive Care Unit (ICU)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Delirium; Respiratory Depression; Overmedication	Device: Acupuncture Therapy	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Supportive Care
Official Title:	Acupuncture for Sedation in the Intensive Care Unit
Study Start Date :	July 2011
Actual Primary Completion Date :	July 2015
Estimated Study Completion Date :	July 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Verum Acupuncture; Subjects will receive verum, or "real," acupuncture.	Device: Acupuncture Therapy; DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days; Other Names: Streitberger Placebo-needles (Gauge 8 x 1.2") 90183900; Special No. 16 (verum needles; Gauge 8 x 1.2") 90183900
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.	Device: Acupuncture Therapy; DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days; Other Names: Streitberger Placebo-needles (Gauge 8 x 1.2") 90183900; Special No. 16 (verum needles; Gauge 8 x 1.2") 90183900

Outcome Measures

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Primary Outcome Measures :

1. Quantity of Sedation [ Time Frame: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. ]
   Quantity of sedation, anxiolytic and analgesic medications.

Secondary Outcome Measures :

1. RAAS Score [ Time Frame: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. ]
   Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'
2. Pain Score [ Time Frame: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. ]
   Measure of pain. Scale of 0-10, with 0 equal to 'No pain' and 10 equal to 'Worst possible pain.'
3. ICU Stay [ Time Frame: Number of days in ICU. ICU length of stay (ILOS) defined as time of arrival in ICU until transfer to ward. ILOS estimated to average two (2) weeks per subject. Assessed up to discharge (estimated 3 weeks). ]
4. Length of ventilator dependence [ Time Frame: Number hours subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks). ]
5. Success of blinding [ Time Frame: RN 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Oregon
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Medical Research Foundation, Oregon

Investigators

Principal Investigator:	Jennifer M Watters, MD	Oregon Health and Science University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Wang SM, Kain ZN. Auricular acupuncture: a potential treatment for anxiety. Anesth Analg. 2001 Feb;92(2):548-53.

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.

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.

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. Review.

Responsible Party:	Jennifer M Watters, Associate Professor of Surgery, Director Surgical Critical Care, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT01362270 History of Changes
Other Study ID Numbers:	MRF 811
First Posted:	May 30, 2011
Last Update Posted:	May 19, 2016
Last Verified:	May 2016

Keywords provided by Jennifer M Watters, Oregon Health and Science University:

Anxiolytics; Sedatives; Acupuncture Therapy

Additional relevant MeSH terms:

Delirium; Respiratory Insufficiency; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases	Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases