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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525860
• Other study ID #: 17-006095
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: August 26, 2019

Study information

• Verified date: November 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acupuncture Therapy
• Atrial Fibrillation
• Post-Operative Atrial Fibrillation

Intervention

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 .

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials