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

A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01621139
Enrollment
20
Registered
2012-06-18
Start date
2011-01-31
Completion date
2013-11-30
Last updated
2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication

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.

Interventions

PROCEDUREAcupuncture

Patients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
RASS (Richmond Agitation Sedation Scale)baseline to six months

Secondary

MeasureTime frame
ABPS (Aberdeen Back Pain Scale)baseline to six months
Pain Scalebaseline to six months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026