Acupuncture for Sedation in the Intensive Care Unit (ICU)

NCT01362270 | Completed Results DMC

• 1 other identifier: MRF 811
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Respiratory Depression; Overmedication

Keywords

Anxiolytics; Sedatives; Acupuncture Therapy

Outcome Measures

Primary Outcomes (1)

• Success of Blinding

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

  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 (2)

• Richmond Agitation-Sedation Scale (RAAS) Score

  Median RAAS score during treatment (5 days)

• 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).

Study Arms (2)

Verum Acupuncture

EXPERIMENTAL

Subjects will receive acupuncture using real acupuncture needles.

Device: Verum Acupuncture

Sham acupuncture

SHAM COMPARATOR

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: Sham Acupuncture

Interventions

Verum Acupuncture DEVICE

DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Also known as: Special No. 16 needles (Gauge 8 x 1.2")

Verum Acupuncture

Sham Acupuncture DEVICE

DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Also known as: Streitberger Placebo-needles (Gauge 8 x 1.2")

Sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma patient ≥ 18 years admitted to the Trauma ICU
• Injury Severity Score (ISS) ≥ 4
• Mechanically ventilated \< 24 hours with anticipated need \> 24 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Medical Research Foundation, Oregon: collaborator

Study Sites (1)

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

Related Publications (5)

• 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.

  PMID: 11818761 BACKGROUND

• 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.

  PMID: 11159266 BACKGROUND

• 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.

  PMID: 18356793 BACKGROUND

• 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.

  PMID: 17641566 BACKGROUND

• 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.

  PMID: 18090028 BACKGROUND

MeSH Terms

Conditions

Delirium; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Samantha Underwood, Research Manager
• Organization: Oregon Health & Science University

underwos@ohsu.edu

503-494-8481

Study Officials

• Jennifer M Watters, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery, Director Surgical Critical Care

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: May 30, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 20, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-03

Locations

US (1)