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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ognjen Gajic, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01621139
First received: March 29, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Mechanical Ventilation Complication
Procedure: Acupuncture
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • RASS (Richmond Agitation Sedation Scale) [ Time Frame: baseline to six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ABPS (Aberdeen Back Pain Scale) [ Time Frame: baseline to six months ] [ Designated as safety issue: Yes ]
  • Pain Scale [ Time Frame: baseline to six months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2011
Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621139

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

No publications provided

Responsible Party: Ognjen Gajic, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01621139     History of Changes
Other Study ID Numbers: 09-001937
Study First Received: March 29, 2012
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014