Back to resultsAcupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting
Primary Purpose
Post-Operative Atrial Fibrillation, Acupuncture Therapy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Post-Operative Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients who have undergone CABG and/or cardiac valve operations.
- Patients developing postoperative atrial fibrillation, and documented by ECG prior to acupuncture intervention, and treated with the common anti arrhythmic treatment of the department.
- Patients moving to the step-down unit on postoperative day 2 or later.
- Ability to provide informed consent.
- Ability to speak English and complete all aspects of this trial.
- At least 18 years of age.
Exclusion Criteria:
- Patients with any other cardiac or non-cardiac concomitant procedures.
- Patients with suspected sternal wound infection and/or with prolonged sternal wound dressing and wound- Vac-system application or open chest wound.
- Patients with abnormal postoperative track staying in the intensive care unit for any clinical reason or hemodynamic compromise.
- Patients with platelet count <50,000
- Patients in a severe immunocompromised state.
- Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture Treatment
No Intervention
Arm Description
20 subjects will be treated with standard of care and acupuncture. Will complete Symptom and Pain questionnaire (VAS) and a Was It Worth It (WIWI) questionnaire each day of study participation (3 days).
20 subjects will be treated with standard of care only. Will complete Symptom and Pain questionnaire (VAS) each day of study participation (3 days).
Outcomes
Primary Outcome Measures
Acupuncture treatment in the hospital setting
The number of patients that complete acupuncture treatment in the hospital setting for patients having undergone heart surgery.
Secondary Outcome Measures
Number of patients with recurrent atrial fibrillation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03525860
Brief Title
Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Primary Aim • Evaluate the feasibility of providing acupuncture in the hospital setting for 20 patients undergoing open heart surgery and subsequently develop arrhythmias.
Secondary Aims
• Evaluate the short-term effect of acupuncture including the effects on patient's arrhythmias, stress, anxiety, and pain measured by Electrocardiogram monitoring and Electrocardiography, VAS scores, and WIWI questionnaire for the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Atrial Fibrillation, Acupuncture Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture Treatment
Arm Type
Experimental
Arm Description
20 subjects will be treated with standard of care and acupuncture.
Will complete Symptom and Pain questionnaire (VAS) and a Was It Worth It (WIWI) questionnaire each day of study participation (3 days).
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
20 subjects will be treated with standard of care only.
Will complete Symptom and Pain questionnaire (VAS) each day of study participation (3 days).
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
The subject is placed in the selected position (lying down or sitting), based on their comfort level. The areas to be needled are prepped with an alcohol swab. Mandatory standards and safety guidelines for acupuncture will be followed.
The acupuncture treatment protocol will be based on Traditional Chinese Medicine (TCM) theory. The TCM treatment strategy is designed to Benefit the Heart, Tonify Heart Qi and Blood, Calm and Sedate Cardiac Excitability and Regulate the Qi. Current literature supports the use of selected acupuncture points as possibly beneficial in regulating the autonomic nervous system, modulating Heart Rate Variability (HRV), relieving chest pain, and reducing arrhythmias.
11 sterile, single use, disposable needles will be placed one by one until all needles are in place.
Needles remain in place for additional 20 minutes or so as the patient remains in the selected position
.
Primary Outcome Measure Information:
Title
Acupuncture treatment in the hospital setting
Description
The number of patients that complete acupuncture treatment in the hospital setting for patients having undergone heart surgery.
Time Frame
3 days post surgery
Secondary Outcome Measure Information:
Title
Number of patients with recurrent atrial fibrillation
Time Frame
3 consecutive days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have undergone CABG and/or cardiac valve operations.
Patients developing postoperative atrial fibrillation, and documented by ECG prior to acupuncture intervention, and treated with the common anti arrhythmic treatment of the department.
Patients moving to the step-down unit on postoperative day 2 or later.
Ability to provide informed consent.
Ability to speak English and complete all aspects of this trial.
At least 18 years of age.
Exclusion Criteria:
Patients with any other cardiac or non-cardiac concomitant procedures.
Patients with suspected sternal wound infection and/or with prolonged sternal wound dressing and wound- Vac-system application or open chest wound.
Patients with abnormal postoperative track staying in the intensive care unit for any clinical reason or hemodynamic compromise.
Patients with platelet count <50,000
Patients in a severe immunocompromised state.
Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaim Leker Locker, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting
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