Trial Outcomes & Findings for Acupuncture for Sedation in the Intensive Care Unit (ICU) (NCT NCT01362270)
NCT ID: NCT01362270
Last Updated: 2020-03-20
Results Overview
Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
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.
Results posted on
2020-03-20
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Met exclusion criteria after 1st session
|
0
|
1
|
|
Overall Study
Met excl. criteria before 1st session
|
1
|
1
|
Baseline Characteristics
Acupuncture for Sedation in the Intensive Care Unit (ICU)
Baseline characteristics by cohort
| Measure |
Verum Acupuncture
n=6 Participants
Subjects will receive acupuncture using real acupuncture needles.
Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
|
Sham Acupuncture
n=7 Participants
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
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.
Outcome measures
| Measure |
Verum Acupuncture
n=6 Participants
Subjects will receive acupuncture using real acupuncture needles.
Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
|
Sham Acupuncture
n=7 Participants
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
|
|---|---|---|
|
Success of Blinding
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Median RAAS score during treatment (5 days)Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'
Outcome measures
| Measure |
Verum Acupuncture
n=6 Participants
Subjects will receive acupuncture using real acupuncture needles.
Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
|
Sham Acupuncture
n=7 Participants
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
|
|---|---|---|
|
Richmond Agitation-Sedation Scale (RAAS) Score
|
-1.4 score on a scale from +4 to -5
Interval -3.1 to -0.4
|
-1.9 score on a scale from +4 to -5
Interval -2.8 to -0.6
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Verum Acupuncture
n=6 Participants
Subjects will receive acupuncture using real acupuncture needles.
Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
|
Sham Acupuncture
n=7 Participants
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
|
|---|---|---|
|
Length of Ventilator Dependence
|
62.1 hours
Standard Deviation 32.4
|
232.8 hours
Standard Deviation 244.4
|
Adverse Events
Verum Acupuncture
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Verum Acupuncture
n=6 participants at risk
Subjects will receive acupuncture using real acupuncture needles.
Verum Acupuncture: DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
|
Sham Acupuncture
n=7 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Bleeding at acupuncture site
|
33.3%
2/6 • Number of events 2 • 30 days
|
0.00%
0/7 • 30 days
|
|
Skin and subcutaneous tissue disorders
Pain at acupuncture site
|
33.3%
2/6 • Number of events 2 • 30 days
|
0.00%
0/7 • 30 days
|
Additional Information
Samantha Underwood, Research Manager
Oregon Health & Science University
Phone: 503-494-8481
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place