Evaluation of Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength and Functional Capacity in Individuals Undergoing Minimally Invasive Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Pulmonary Function - Forced Vital Capacity (FVC)
研究概览
简要总结
The goal of this observational study is to evaluate pulmonary function, respiratory muscle strength, peripheral muscle strength, and functional capacity in adult patients undergoing either minimally invasive cardiac surgery (via mini-thoracotomy) or conventional sternotomy for coronary artery bypass grafting (CABG) at Gülhane Training and Research Hospital.The main questions it aims to answer are:
Does minimally invasive cardiac surgery preserve pulmonary function better than conventional sternotomy? Does minimally invasive cardiac surgery result in less respiratory and peripheral muscle weakness compared to conventional sternotomy? Researchers will compare patients undergoing minimally invasive surgery with those undergoing conventional sternotomy to determine differences in pulmonary function, respiratory muscle strength, peripheral muscle strength, and functional capacity.
Participants will:
Undergo preoperative and postoperative (day 4) assessments including spirometry, inspiratory/expiratory mouth pressure measurements, and peripheral muscle strength testing (handgrip, shoulder flexion/abduction, hip flexion, knee extension).
Perform functional capacity tests (30-second sit-to-stand test, 6-minute walk test).
Complete questionnaires assessing pain (McGill Pain Questionnaire) and fear of movement (Tampa Scale of Kinesiophobia).
详细描述
Coronary artery bypass grafting (CABG) is one of the most commonly performed surgical procedures for patients with complex coronary artery disease. While the standard approach is through median sternotomy, minimally invasive cardiac surgery performed via mini-thoracotomy has gained popularity due to potential benefits such as smaller incisions, reduced surgical trauma, lower risk of sternal complications, shorter hospital stays, and faster mobilization. However, its effects on pulmonary function, respiratory muscle strength, peripheral muscle strength, and functional capacity have not been sufficiently clarified.
Postoperative pulmonary complications are a significant concern in cardiac surgery. Procedures involving cardiopulmonary bypass may result in atelectasis, pneumonia, pleural effusion, phrenic nerve injury, and diaphragm dysfunction. These complications can impair respiratory mechanics, delay rehabilitation, and increase morbidity and mortality. Therefore, identifying surgical approaches that better preserve pulmonary and muscular function is of great clinical importance.
This observational study will prospectively evaluate adult patients undergoing CABG at Gülhane Training and Research Hospital, comparing two groups: those receiving minimally invasive cardiac surgery via mini-thoracotomy and those undergoing conventional sternotomy. The primary outcomes are changes in pulmonary function parameters measured by spirometry (FVC, FEV1, PEF) from baseline to postoperative day 4. Secondary outcomes include respiratory muscle strength (MIP, MEP), peripheral muscle strength (handgrip, shoulder flexion/abduction, hip flexion, knee extension), functional capacity (30-second sit-to-stand test, 6-minute walk test), pain intensity (McGill Pain Questionnaire), and fear of movement (Tampa Scale of Kinesiophobia).
All assessments will be performed twice: before surgery (preoperative baseline) and on postoperative day 4. This time frame was chosen to capture early postoperative functional changes, which may influence short-term recovery and rehabilitation strategies. By comparing the two surgical techniques, this study aims to determine whether minimally invasive cardiac surgery provides better preservation of pulmonary and muscular function, ultimately supporting improved patient-centered outcomes and guiding clinical decision-making in surgical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years
- •Scheduled for elective cardiac surgery via either minimally invasive approach (mini-thoracotomy) or conventional sternotomy at Gülhane Training and Research Hospital
- •Able to provide written informed consent
排除标准
- •Previous history of cardiac surgery
- •Presence of orthopedic or neurological disorders affecting mobility or muscle strength
- •Postoperative cerebrovascular event
- •Requirement for mechanical ventilation > 24 hours postoperatively
- •Intensive care unit stay > 48 hours
结局指标
主要结局
Change in Pulmonary Function - Forced Vital Capacity (FVC)
时间窗: Baseline [preoperative] and postoperative day 4)
Forced Vital Capacity measured by spirometry. Results will be reported in liters (L).
Change in Pulmonary Function - Forced Expiratory Volume in 1 second (FEV1)
时间窗: Baseline to postoperative day 4
Forced Expiratory Volume in 1 second measured by spirometry. Results will be reported in liters (L).
Change in Respiratory Muscle Strength - Maximal Inspiratory Pressure (MIP)
时间窗: Baseline [preoperative] and postoperative day 4
Inspiratory muscle strength measured with mouth pressure device. Results will be reported in cmH₂O.
Change in Respiratory Muscle Strength - Maximal Expiratory Pressure (MEP)
时间窗: Baseline [preoperative] and postoperative day 4
Expiratory muscle strength measured with mouth pressure device. Results will be reported in cmH₂O.
Change in Handgrip Strength
时间窗: Baseline to postoperative day 4
Handgrip strength measured with handheld dynamometer. Results will be reported in kilograms (kg).
Change in Knee Extension Strength
时间窗: Baseline to postoperative day 4
Knee extension strength measured with handheld dynamometer. Results will be reported in kilograms (kg).
Change in Functional Capacity - 30-Second Sit-to-Stand Test
时间窗: Baseline to postoperative day 4
Number of repetitions performed during the 30-second sit-to-stand test. Results will be reported as number of repetitions.
Change in Functional Capacity - 6-Minute Walk Distance
时间窗: Baseline to postoperative day 4
Distance covered during the 6-minute walk test. Results will be reported in meters (m).
次要结局
- Change in Pain Intensity - McGill Pain Questionnaire(Baseline and postoperative day 4)
- Change in Kinesiophobia - Tampa Scale of Kinesiophobia (TSK-17)(Baseline and postoperative day 4)
研究者
Zehra Can Karahan
Asst. Prof.
Atılım University
