Acupuncture for Sedation in the Intensive Care Unit (ICU)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Neurology, Psychiatric, Pulmonary |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/20/2016 |
| Start Date: | July 2011 |
| End Date: | July 2016 |
Acupuncture for Sedation in the Intensive Care Unit
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.
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.
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
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