Acupuncture Therapy Clinical Trial
Official title:
The Feasibility of Acupuncture Treatment in the Post-Operative Cardio-Thoracic Setting for Arrhythmias in Patients Undergoing Open Heart Surgery- A Pilot Study
NCT number | NCT03525860 |
Other study ID # | 17-006095 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 26, 2018 |
Est. completion date | August 26, 2019 |
Verified date | November 2021 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A feasibility study on the provision of acupuncture treatment in the hospital to 20 patients who have undergone open heart surgery procedures. The acupuncture treatments may begin as early as postoperative Day 2.
Status | Completed |
Enrollment | 47 |
Est. completion date | August 26, 2019 |
Est. primary completion date | August 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients who have undergone CABG and/or cardiac valve operations. 2. Patients developing postoperative atrial fibrillation, and documented by ECG prior to acupuncture intervention, and treated with the common anti arrhythmic treatment of the department. 3. Patients moving to the step-down unit on postoperative day 2 or later. 4. Ability to provide informed consent. 5. Ability to speak English and complete all aspects of this trial. 6. At least 18 years of age. Exclusion Criteria: 1. Patients with any other cardiac or non-cardiac concomitant procedures. 2. Patients with suspected sternal wound infection and/or with prolonged sternal wound dressing and wound- Vac-system application or open chest wound. 3. Patients with abnormal postoperative track staying in the intensive care unit for any clinical reason or hemodynamic compromise. 4. Patients with platelet count <50,000 5. Patients in a severe immunocompromised state. 6. Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acupuncture treatment in the hospital setting | The number of patients that complete acupuncture treatment in the hospital setting for patients having undergone heart surgery. | 3 days post surgery | |
Secondary | Number of patients with recurrent atrial fibrillation | 3 consecutive days post-surgery |
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