Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting

The Feasibility of Acupuncture Treatment in the Post-Operative Cardio-Thoracic Setting for Arrhythmias in Patients Undergoing Open Heart Surgery- A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Acupuncture Therapy; Post-Operative Atrial Fibrillation
• Intervention / Treatment: Procedure: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture Treatment; 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).	Procedure: Acupuncture; 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 .
NO_INTERVENTION: No Intervention; 20 subjects will be treated with standard of care only. Will complete Symptom and Pain questionnaire (VAS) each day of study participation (3 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of patients with recurrent atrial fibrillation	3 consecutive days post-surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Chaim Leker Locker, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2018
• Primary Completion (ACTUAL): August 26, 2019
• Study Completion (ACTUAL): August 26, 2019

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (ACTUAL): May 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 17-006095

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No