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

NCT ID: NCT01621139

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Real acupuncture

Real acupuncture group

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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

Sham acupuncture

Sham acupuncture group

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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

Interventions

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Acupuncture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ognjen Gajic

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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09-001937

Identifier Type: -

Identifier Source: org_study_id