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

NCT03525860 | Completed

• 1 other identifier: 17-006095
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Operative Atrial Fibrillation; Acupuncture Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients with recurrent atrial fibrillation

  3 consecutive days post-surgery

Study Arms (2)

Acupuncture Treatment

EXPERIMENTAL

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

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).

Interventions

Acupuncture PROCEDURE

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 .

Acupuncture Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Chaim Leker Locker, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 16, 2018
• Study Start: July 26, 2018
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

US (1)