A Pilot Clinical Trial to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation

Phase 1

Completed

Brief Summary: The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite recovery process, and 4) improve the quality of life.

Recruitment & Eligibility

Inclusion Criteria

Consecutive male and post-menopausal female patients expected to require more than 24 hours of mechanical ventilation will be included.

Exclusion Criteria

Children < 18 years of age
Patients with active resuscitation (fluid boluses greater than 2 Liter per hour, rapid transfusions, titration of vasoactive medication)
Patients with hemodynamic instability: heart rate less than 40/min or greater than 120/min, SBP < 90 or > 180 mm Hg for longer than 2 continuous hours
Patients who are pregnant or pre-menopausal
Patients with expected survival less than 6 3 months
Major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupuncture treatment areas.
Patients with a pacemaker or other implanted electronic device

Arm && Interventions

Group	Intervention	Description
Real acupuncture	Acupuncture	Real acupuncture group
Sham acupuncture	Acupuncture	Sham acupuncture group

Primary Outcome Measures

Name	Time	Method
RASS (Richmond Agitation Sedation Scale)	baseline to six months

Secondary Outcome Measures

Name	Time	Method
ABPS (Aberdeen Back Pain Scale)	baseline to six months
Pain Scale	baseline to six months

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