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

Not Applicable

Completed

• Conditions: Post-Operative Atrial Fibrillation; Acupuncture Therapy

• Registration Number: NCT03525860
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-16
• Study Start: 2018-07-26
• Primary Completion: 2019-08-26
• Study Completion: 2019-08-26
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acupuncture treatment in the hospital setting	3 days post surgery	The number of patients that complete acupuncture treatment in the hospital setting for patients having undergone heart surgery.

Secondary Outcome Measures

Name	Time	Method
Number of patients with recurrent atrial fibrillation	3 consecutive days post-surgery

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States