Acupuncture for Sedation in the Intensive Care Unit (ICU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oregon Health and Science University
Sponsor:
Collaborator:
Medical Research Foundation, Oregon
Information provided by (Responsible Party):
Jennifer M Watters, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01362270
First received: May 25, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Delirium
Respiratory Depression
Overmedication
Device: Acupuncture Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Sedation in the Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Quantity of sedation, anxiolytic and analgesic medications.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'

  • 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. ] [ Designated as safety issue: No ]
    Measure of pain. Scale of 0-10, with 0 equal to 'No pain' and 10 equal to 'Worst possible pain.'

  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362270

Contacts
Contact: Jennifer M Watters, MD 503-494-5300 wattersj@ohsu.edu
Contact: Kate M Watson, BA 503-494-4315 watsonka@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University (OHSU) Recruiting
Portland, Oregon, United States, 97239
Contact: Jennifer M Watters, MD    503-494-5300    wattersj@ohsu.edu   
Contact: Kate M Watson, BA    503-494-4315    watsonka@ohsu.edu   
Principal Investigator: Jennifer M Watters, MD         
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

Additional Information:
Publications:
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
Study First Received: May 25, 2011
Last Updated: November 21, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Anxiolytics
Sedatives
Acupuncture Therapy

Additional relevant MeSH terms:
Delirium
Depression
Depressive Disorder
Respiratory Insufficiency
Drug Overdose
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Respiration Disorders
Respiratory Tract Diseases
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 28, 2014