Acupuncture for Sedation in the Intensive Care Unit (ICU)

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01362270
• Collaborator: Medical Research Foundation, Oregon (Other)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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: Verum Acupuncture; Device: Sham Acupuncture	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 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: Jul 1, 2011
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Success of Blinding [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 Outcome Measures

1. Richmond Agitation-Sedation Scale (RAAS) Score [Median RAAS score during treatment (5 days)]

   Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'

2. 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).]

   Number of hours of ventilator use

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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

• Responsible Party: Jennifer M Watters, Associate Professor of Surgery, Director Surgical Critical Care, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT01362270
• Other Study ID Numbers: MRF 811
• First Posted: May 30, 2011
• Last Update Posted: Mar 20, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Jennifer M Watters, Associate Professor of Surgery, Director Surgical Critical Care, Oregon Health and Science University: Anxiolytics; Sedatives; Acupuncture Therapy
• Additional relevant MeSH terms: Respiratory Insufficiency; Delirium

Study Results

Participant Flow

Arm/Group Title	Verum Acupuncture	Sham Acupuncture
Arm/Group Description	Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days	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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
Period Title: Overall Study
STARTED	7	8
COMPLETED	5	6
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Verum Acupuncture	Sham Acupuncture	Total
Arm/Group Description	Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days	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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days	Total of all reporting groups
Overall Participants	6	7	13
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 83.3%	6 85.7%	11 84.6%
>=65 years	1 16.7%	1 14.3%	2 15.4%
Sex: Female, Male (Count of Participants)
Female	2 33.3%	3 42.9%	5 38.5%
Male	4 66.7%	4 57.1%	8 61.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	4 66.7%	6 85.7%	10 76.9%
Unknown or Not Reported	2 33.3%	1 14.3%	3 23.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 14.3%	1 7.7%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	4 66.7%	5 71.4%	9 69.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 33.3%	1 14.3%	3 23.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Number of participants successfully receiving assigned intervention without the care team, family, or subject knowing which treatment was given.

Arm/Group Title	Verum Acupuncture	Sham Acupuncture
Arm/Group Description	Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days	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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
Measure Participants	6	7
Count of Participants [Participants]	1 16.7%	1 14.3%

2. Secondary Outcome

Title	Richmond Agitation-Sedation Scale (RAAS) Score
Description	Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'
Time Frame	Median RAAS score during treatment (5 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Verum Acupuncture	Sham Acupuncture
Arm/Group Description	Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days	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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
Measure Participants	6	7
Median (Inter-Quartile Range) [score on a scale from +4 to -5]	-1.4	-1.9

3. Secondary Outcome

Title	Length of Ventilator Dependence
Description	Number of hours of ventilator use
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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Verum Acupuncture	Sham Acupuncture
Arm/Group Description	Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days	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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
Measure Participants	6	7
Mean (Standard Deviation) [hours]	62.1 (32.4)	232.8 (244.4)

Adverse Events

Time Frame	30 days
Arm/Group Title	Verum Acupuncture		Sham Acupuncture
Arm/Group Description	Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days		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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
All Cause Mortality
	Verum Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Verum Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Verum Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)		0/7 (0%)
Skin and subcutaneous tissue disorders
Bleeding at acupuncture site	2/6 (33.3%)	2	0/7 (0%)	0
Pain at acupuncture site	2/6 (33.3%)	2	0/7 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.