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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01621139
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Ognjen Gajic, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Procedure: Acupuncture Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation
Study Start Date : January 2011
Primary Completion Date : July 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Real acupuncture
Real acupuncture group
Procedure: Acupuncture
Patients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group
Sham Comparator: Sham acupuncture
Sham acupuncture group
Procedure: Acupuncture
Patients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group



Primary Outcome Measures :
  1. RASS (Richmond Agitation Sedation Scale) [ Time Frame: baseline to six months ]

Secondary Outcome Measures :
  1. ABPS (Aberdeen Back Pain Scale) [ Time Frame: baseline to six months ]
  2. Pain Scale [ Time Frame: baseline to six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621139


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic

Responsible Party: Ognjen Gajic, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01621139     History of Changes
Other Study ID Numbers: 09-001937
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013