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NCT Number: NCT05430568

Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery

Robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. Studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion volume during operation, re-operation rate, post-operation stroke rate and length of hospitalization. However, most studies focused on the comparison of complications of different procedures, and the investigation of cardiopulmonary function recovery is still lacking. Thus our study is to compare the functional outcomes between patients that undergo different surgical procedures.

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Key information

Conditions

Coronary Bypass Graft Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Valvular Heart Disease

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physical Medicine and Rehabilitation

Taichung, Taiwan, 40705

About this study

The study is a prospective cohort study. The experimental group will include 40 patients, consisting 20 after robotic coronary artery bypass grafting and 20 after robotic valvuloplasty. The control group will include 20 patients for each conventional procedure.

Once decided the surgery type, the surgeon will consult the rehabilitation department and the director of this trial for inform consent. The recruitment and allocation will only be done after the patient has decided which type of surgery to receive. However, in case of change of surgery type, the patient will be excluded from the trial.

Cardiopulmonary exercise testing, 6-minute walking test and questionnaires about wound pain and cardiac functional status will be performed before surgery, two weeks after discharge and three months after discharge respectively. Primary outcomes include the change of maximal oxygen consumption (VO2), anaerobic threshold and the result of six minute walking test before and after surgery. Secondary outcomes include the change vital capacity (FVC), resting heart rate, oxygen pulse (O2 pulse), wound pain visual analog scale (VAS) and Duke Activity Status Index (DASI) before and after surgery.

The hypothesis of this study is that patients who undergo robot-assisted surgery will have better cardiopulmonary outcomes than those receive conventional surgery

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient who undergo surgery for coronary artery bypass graft or valvular replacement.

Exclusion criteria

  • pregnant
  • patients who receive more than one type of surgery
  • severe complications after surgery (ex. respiratory failure, stroke) and stayed in hospital for more than 2 weeks.
  • cannot perform the cardiopulmonary exercise testing
  • other contraindications for cardiopulmonary exercise testing

Treatment and study plan

Robot-assisted surgery

Procedure
  • traditional sternotomy for coronary bypass graft or valvular replacement
  • robot-assisted surgery for coronary bypass graft or valvular replacement

Other names: sternotomy

Primary outcomes

  1. Change of maximal oxygen consumption post-surgery

    Time frame: pre-operation to 2 weeks post-operation

    the change of maximal oxygen consumption from surgery before to 2 weeks after surgery

  2. Change of maximal oxygen consumption in 3 months

    Time frame: pre-operation to 3 months post-operation

    the change of maximal oxygen consumption from before surgery to 3 months after surgery

  3. Change of anaerobic threshold post surgery

    Time frame: pre-operation to 2 weeks post-operation

    the change of the onset of lactate accumulation in blood from before surgery to 2 weeks after surgery

  4. Change of anaerobic threshold in 3 months

    Time frame: pre-operation to 3 months post-operation

    the change of the onset of lactate accumulation in blood from before surgery to 3 months after surgery

  5. Change of six minute walking test result post-surgery

    Time frame: pre-operation to 2 weeks post-operation

    the change of six minute walking test result from before surgery to 2 weeks after surgery

  6. Change of six minute walking test result in 3 months

    Time frame: pre-operation to 3 months post-operation

    the change of six minute walking test result from before surgery to 3 months after surgery

Secondary outcomes

  1. Change of vital capacity post-surgery

    Time frame: pre-operation to 2 weeks post-operation

    the change of vital capacity during pulmonary function testing from before surgery to 2 weeks after surgery

  2. Change of vital capacity in 3 months

    Time frame: pre-operation to 3 months post-operation

    the change of vital capacity during pulmonary function testing from before surgery to 3 months after surgery

  3. Change of respiratory flow post-surgery

    Time frame: pre-operation to 2 weeks post-operation

    the change of the ratio of air volume on exhalation to vital capacity during the first second in the pulmonary function testing from before surgery to 2 weeks after surgery

  4. Change of respiratory flow ratio in 3 months

    Time frame: pre-operation to 3 months post-operation

    the change of the ratio of air volume on exhalation to vital capacity during the first second in the pulmonary function testing from before surgery to 3 months after surgery

  5. Change of resting heart rate post-surgery

    Time frame: pre-operation to 2 weeks post-operation

    the change of resting heart rate from before surgery to 2 weeks after surgery

  6. Change of resting heart rate in 3 months

    Time frame: pre-operation to 3 months post-operation

    the change of resting heart rate from before surgery to 3 months after surgery

  7. Change of oxygen pulse post-surgery

    Time frame: pre-operation to 2 weeks post-operation

    the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 2 weeks after surgery

  8. Change of oxygen pulse in 3 months

    Time frame: pre-operation to 3 months post-operation

    the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 3 months after surgery

  9. pain post-surgery

    Time frame: 2 weeks post-operation

    pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 2 weeks after surgery

  10. pain in 3 months

    Time frame: 3 months post-operation

    pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 3 months after surgery

  11. Change of activity status post-surgery

    Time frame: pre-operation to 2 weeks post-operation

    the change of the Duke Activity Status Index (DASI) score from before surgery to 2 weeks after surgery.

    The DASI is a score ranging from 0 to 58.2. A higher score indicates a better cardiorespiratory fitness.

  12. Change of activity status in 3 months

    Time frame: pre-operation to 3 months post-operation

    the change of the Duke Activity Status Index (DASI) score from before surgery to 3 months after surgery The DASI is a score ranging from 0 to 58.2. A higher score indicates a better cardiorespiratory fitness.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuchun Lee, MD

CONTACT

[email protected]

886-4-23592525 ext. 3207

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 24, 2022
Registry last updated
Sep 9, 2025

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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