Overview

This trial is active, not recruiting.

Conditions delirium, respiratory depression, overmedication
Treatment acupuncture therapy
Phase phase 4
Sponsor Oregon Health and Science University
Collaborator Medical Research Foundation, Oregon
Start date July 2011
End date July 2015
Trial size 60 participants
Trial identifier NCT01362270, MRF 811

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Subjects will receive verum, or "real," acupuncture.
acupuncture therapy Streitberger Placebo-needles (Gauge 8 x 1.2") 90183900
DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
(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.
acupuncture therapy Streitberger Placebo-needles (Gauge 8 x 1.2") 90183900
DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.
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.
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).
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).
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Acupuncture for Sedation in the Intensive Care Unit
Principal investigator Jennifer M Watters, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.