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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014