The Effect of Low Tidal Volume Ventilation on Diaphragmatic Excursion in Cardiopulmonary Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Diaphragmatic Excursion Measured by Ultrasound
研究概览
简要总结
The goal of this clinical trial is to evaluate whether low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) surgery helps preserve diaphragmatic excursion in adult patients undergoing coronary artery bypass grafting (CABG). The study will also assess the relationship between LTV ventilation and postoperative pulmonary complications, such as atelectasis, pleural effusion, and pneumonia.
The main questions this trial aims to answer are:
Does LTV ventilation better preserve diaphragmatic motion compared to apnea during CPB?
Are postoperative pulmonary complications less frequent in patients receiving LTV?
Does LTV contribute to shorter extubation times and ICU stays?
Researchers will compare LTV ventilation with apnea (standard care) during CPB to assess its effects on diaphragmatic excursion, measured via ultrasound, and postoperative respiratory outcomes.
Participants will:
Undergo elective CABG surgery under general anesthesia
Be randomly assigned to receive either LTV ventilation or apnea during CPB
Have diaphragmatic excursion measured by ultrasound before surgery, before extubation, and 24 hours after surgery
Be monitored for postoperative pulmonary complications (atelectasis, effusion, pneumonia), extubation time, and ICU length of stay
Ultrasound will be used to measure diaphragmatic excursion (DE) in quiet and deep breathing. DE below 10 mm will be considered as diaphragmatic paralysis. Postoperative respiratory assessments will include blood gas analysis (PaO₂/FiO₂ ratio), clinical respiratory parameters, and imaging findings.
This is a prospective, single-center, assessor-blinded randomized controlled trial. Patients and outcome assessors will be blinded to group allocation. The study will be conducted at the Anesthesiology Clinic of Konya City Hospital and is expected to enroll 60 patients.
详细描述
oronary artery bypass grafting (CABG) surgery performed under cardiopulmonary bypass (CPB) is a complex procedure frequently associated with postoperative pulmonary complications (PPCs). During CPB, mechanical ventilation is usually paused (apnea), which leads to temporary diaphragmatic inactivity. The diaphragm, being a rhythmically contracting muscle under normal physiological conditions, may experience transient dysfunction or even paralysis due to this intraoperative inactivity. Several mechanisms, including loss of neuromechanical coupling, disrupted neuromuscular signaling, altered venous return, and impaired diaphragmatic oxygenation and metabolism, are thought to contribute to this process.
Reduced diaphragmatic motion can create a favorable condition for atelectasis, impair oxygenation, and increase the risk of infection in the postoperative period. The resulting transient diaphragmatic dysfunction is considered a potential contributor to the development of PPCs such as pneumonia, pleural effusion, and prolonged mechanical ventilation.
Recent research has focused on the protective effects of low tidal volume (LTV) ventilation in surgical and critical care settings. However, limited studies have evaluated its direct impact on diaphragmatic function during CPB, particularly in the context of CABG surgery. There is a need to investigate whether intraoperative application of LTV ventilation during CPB can help preserve diaphragmatic excursion (DE) and reduce PPCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only participants and outcome assessors are masked in this study. No additional masked parties beyond those listed.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Male or female patients
- •American Society of Anesthesiologists (ASA) physical status class II or III
- •Scheduled for elective coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB)
- •Provided written informed consent to participate in the study -
排除标准
- •History of neuromuscular disease
- •History of thoracic surgery
- •History of pneumothorax or ascites
- •Chronic respiratory failure
- •Pulmonary hypertension or right ventricular failure
- •Emergency surgery
- •Inability to perform diaphragm ultrasonographic measurements
- •Refusal to participate in the study
研究组 & 干预措施
Group Low
Low Tidal Volume Ventilation Group (LTV)
干预措施: Low Tidal Volume Ventilation During CPB (Other)
Group Apnea
Apnea Group (Control Group)
结局指标
主要结局
Change in Diaphragmatic Excursion Measured by Ultrasound
时间窗: Baseline (30 minutes before transfer to the operating room (Preoperative baseline) Postoperative ( Immediately Before Extubation) 24 Hours After Surgery (24 hours after the end of surgery)
Diaphragmatic excursion (DE) will be measured using M-mode ultrasonography with a 2-5 MHz convex probe placed in the right mid-clavicular subcostal view. Measurements will be performed during both quiet and deep breathing maneuvers. A DE value of ≤10 mm will be considered indicative of diaphragmatic paralysis. The average of three consecutive measurements will be recorded at each time point. The main comparison will assess postoperative DE values between groups receiving low tidal volume ventilation and apnea during CPB.
次要结局
- Time to Extubation(From ICU Admission to Extubation (Up to 24 Hours Postoperatively))
- Incidence of Postoperative Pulmonary Complications(First 3 Days After Surgery and Prior to ICU Discharge)
研究者
Nuran Akıncı Ekinci
MD, Anesthesiologist, Department of Anesthesiology
Konya City Hospital