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

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05430568
• Other study ID #: CE22214A
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Taichung Veterans General Hospital
• Contact: Yuchun Lee, MD
• Phone: 886-4-23592525
• Email: lyczoj[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of maximal oxygen consumption post-surgery	the change of maximal oxygen consumption from surgery before to 2 weeks after surgery	pre-operation to 2 weeks post-operation
Primary	Change of maximal oxygen consumption in 3 months	the change of maximal oxygen consumption from before surgery to 3 months after surgery	pre-operation to 3 months post-operation
Primary	Change of anaerobic threshold post surgery	the change of the onset of lactate accumulation in blood from before surgery to 2 weeks after surgery	pre-operation to 2 weeks post-operation
Primary	Change of anaerobic threshold in 3 months	the change of the onset of lactate accumulation in blood from before surgery to 3 months after surgery	pre-operation to 3 months post-operation
Primary	Change of six minute walking test result post-surgery	the change of six minute walking test result from before surgery to 2 weeks after surgery	pre-operation to 2 weeks post-operation
Primary	Change of six minute walking test result in 3 months	the change of six minute walking test result from before surgery to 3 months after surgery	pre-operation to 3 months post-operation
Secondary	Change of vital capacity post-surgery	the change of vital capacity during pulmonary function testing from before surgery to 2 weeks after surgery	pre-operation to 2 weeks post-operation
Secondary	Change of vital capacity in 3 months	the change of vital capacity during pulmonary function testing from before surgery to 3 months after surgery	pre-operation to 3 months post-operation
Secondary	Change of respiratory flow post-surgery	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	pre-operation to 2 weeks post-operation
Secondary	Change of respiratory flow ratio in 3 months	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	pre-operation to 3 months post-operation
Secondary	Change of resting heart rate post-surgery	the change of resting heart rate from before surgery to 2 weeks after surgery	pre-operation to 2 weeks post-operation
Secondary	Change of resting heart rate in 3 months	the change of resting heart rate from before surgery to 3 months after surgery	pre-operation to 3 months post-operation
Secondary	Change of oxygen pulse post-surgery	the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 2 weeks after surgery	pre-operation to 2 weeks post-operation
Secondary	Change of oxygen pulse in 3 months	the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 3 months after surgery	pre-operation to 3 months post-operation
Secondary	pain post-surgery	pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 2 weeks after surgery	2 weeks post-operation
Secondary	pain in 3 months	pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 3 months after surgery	3 months post-operation
Secondary	Change of activity status post-surgery	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.	pre-operation to 2 weeks post-operation
Secondary	Change of activity status in 3 months	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.	pre-operation to 3 months post-operation