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| Name | Class |
|---|---|
| Medical Research Foundation, Oregon | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum Acupuncture | Experimental | Subjects will receive acupuncture using real acupuncture needles. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum Acupuncture | Device | DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Length of Ventilator Dependence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M Watters, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11818761 | Background | 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. | |
| 11159266 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Verum Acupuncture | Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days |
| FG001 | 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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Verum Acupuncture | Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days |
| BG001 | Sham Acupuncture |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants successfully receiving assigned intervention without the care team, family, or subject knowing which treatment was given. | Posted | Count of Participants | Participants | 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. |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum Acupuncture | Subjects will receive acupuncture using real acupuncture needles. Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding at acupuncture site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha Underwood, Research Manager | Oregon Health & Science University | 503-494-8481 | underwos@ohsu.edu |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Sham Acupuncture | Device | DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days |
|
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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). |
| 18356793 | 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. |
| 17641566 | 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. |
| 18090028 | 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. |
| Met excl. criteria before 1st session |
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days |
|
|
| Secondary | Richmond Agitation-Sedation Scale (RAAS) Score | Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.' | Posted | Median | Inter-Quartile Range | score on a scale from +4 to -5 | Median RAAS score during treatment (5 days) |
|
|
|
| Secondary | Length of Ventilator Dependence | Number of hours of ventilator use | Posted | Mean | Standard Deviation | hours | Number hourss subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks). |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | 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. Sham Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days | 0 | 7 | 0 | 7 |
| Pain at acupuncture site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |