Delirium, Overmedication, Respiratory Depression
Conditions
Keywords
Anxiolytics, Sedatives, Acupuncture Therapy
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.
Interventions
DEVICEVerum Acupuncture
DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
DEVICESham Acupuncture
DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
Sponsors
Medical Research Foundation, Oregon
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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.' |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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 | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Met excl. criteria before 1st session | 1 | 1 |
| Overall Study | Met exclusion criteria after 1st session | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Verum Acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
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.
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.
Population: Number of participants successfully receiving assigned intervention without the care team, family, or subject knowing which treatment was given.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Verum Acupuncture | Success of Blinding | 1 Participants |
| Sham Acupuncture | Success of Blinding | 1 Participants |
Secondary
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verum Acupuncture | Length of Ventilator Dependence | 62.1 hours | Standard Deviation 32.4 |
| Sham Acupuncture | Length of Ventilator Dependence | 232.8 hours | Standard Deviation 244.4 |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Verum Acupuncture | Richmond Agitation-Sedation Scale (RAAS) Score | -1.4 score on a scale from +4 to -5 |
| Sham Acupuncture | Richmond Agitation-Sedation Scale (RAAS) Score | -1.9 score on a scale from +4 to -5 |