Acupuncture for Sedation in the Intensive Care Unit (ICU)

Delirium Clinical Trial

Official title:

Acupuncture for Sedation in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362270
• Other study ID #: MRF 811
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: July 2015

Study information

• Verified date: March 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Overmedication
• Respiratory Depression
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University (OHSU)	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Medical Research Foundation, Oregon

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Richmond Agitation-Sedation Scale (RAAS) Score	Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'	Median RAAS score during treatment (5 days)
Secondary	Length of Ventilator Dependence	Number of hours of ventilator use	Number hourss subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks).