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

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Mayo Clinic

Status and phase

Completed
Phase 2
Phase 1

Conditions

Mechanical Ventilation Complication

Treatments

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01621139
09-001937

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Real acupuncture
Experimental group
Description:
Real acupuncture group
Treatment:
Procedure: Acupuncture
Sham acupuncture
Sham Comparator group
Description:
Sham acupuncture group
Treatment:
Procedure: Acupuncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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