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OpenTrials
Completed

NCT Number: NCT03525860

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

.

Primary outcomes

  1. Acupuncture treatment in the hospital setting

    Time frame: 3 days post surgery

    The number of patients that complete acupuncture treatment in the hospital setting for patients having undergone heart surgery.

Secondary outcomes

  1. Number of patients with recurrent atrial fibrillation

    Time frame: 3 consecutive days post-surgery

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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