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临床试验/NCT07172529
NCT07172529进行中(未招募)不适用

Evaluation of Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength and Functional Capacity in Individuals Undergoing Minimally Invasive Cardiac Surgery

Zehra Can Karahan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月1日最近更新:
适应症

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

发起方
Zehra Can Karahan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zehra Can Karahan

Asst. Prof.

Atılım University

研究点 (1)

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