An interventional study of Verum Acupuncture and Sham Acupuncture in Delirium, Respiratory Depression and Overmedication, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-20.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Supportive care
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.
1,071 studies on the registry are indexed under Delirium; 239 are open to participants now.
This study's enrollment of 15 is below the median of 119 across 608 interventional studies indexed under Delirium.
Browse Delirium studies →Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.
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Exclusion Criteria:
Subjects will receive acupuncture using real acupuncture needles.
Device: Verum 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
Also known as: Special No. 16 needles (Gauge 8 x 1.2")
DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
Also known as: Streitberger Placebo-needles (Gauge 8 x 1.2")
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.
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.
Richmond Agitation-Sedation Scale (RAAS) Score
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)
Length of Ventilator Dependence
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).
| Milestone | Verum Acupuncture | Sham Acupuncture |
|---|---|---|
| Started | 7 | 8 |
| Completed | 5 | 6 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Met exclusion criteria after 1st session | 0 | 1 |
| Withdrew: Met excl. criteria before 1st session | 1 | 1 |
Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.
| Participants | Verum Acupuncture | Sham Acupuncture |
|---|---|---|
| Success of Blinding | 1 | 1 |
Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'
| score on a scale from +4 to -5 | Verum Acupuncture | Sham Acupuncture |
|---|---|---|
| Richmond Agitation-Sedation Scale (RAAS) Score | -1.4 (-3.1 to -0.4) | -1.9 (-2.8 to -0.6) |
Number of hours of ventilator use
| hours | Verum Acupuncture | Sham Acupuncture |
|---|---|---|
| Length of Ventilator Dependence | 62.1 ± 32.4 | 232.8 ± 244.4 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Verum Acupuncture | — | 0/6 (0%) | 2/6 (33.3%) |
| Sham Acupuncture | — | 0/7 (0%) | 0/7 (0%) |
| Event | Verum Acupuncture | Sham Acupuncture |
|---|---|---|
| Bleeding at acupuncture siteSkin and subcutaneous tissue disorders | 2/6 | 0/7 |
| Pain at acupuncture siteSkin and subcutaneous tissue disorders | 2/6 | 0/7 |
| Age, Categorical(Participants) | Verum Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 6 | 11 |
| >=65 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Verum Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Verum Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 6 | 10 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Verum Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 5 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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