Comparison of Hemodynamic and Pulmonary Outcomes Between Single-Step and Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in Cardiac Index
研究概览
简要总结
This prospective randomized controlled trial aims to compare the hemodynamic and pulmonary effects of single-step and stepwise lung recruitment maneuvers in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. After separation from cardiopulmonary bypass, patients will be randomized to receive either a single-step sustained inflation recruitment maneuver or a stepwise incremental recruitment maneuver, both combined with 8 cmH₂O positive end-expiratory pressure. The primary outcome is the change in cardiac index before and after the recruitment maneuver. Secondary outcomes include lung ultrasound atelectasis score, and hemodynamic parameters.
详细描述
Atelectasis frequently develops after cardiopulmonary bypass due to lung ischemia-reperfusion injury, inflammatory response, and mechanical factors related to cardiac surgery. Lung recruitment maneuvers are commonly used to improve lung aeration and oxygenation; however, increased intrathoracic pressure during recruitment may negatively affect venous return and cardiac output.
In this randomized controlled trial, adult patients undergoing elective open-heart surgery with cardiopulmonary bypass will be allocated to receive either a single-step sustained inflation recruitment maneuver or a stepwise incremental recruitment maneuver, both combined with 8 cmH₂O positive end-expiratory pressure after separation from cardiopulmonary bypass. Hemodynamic variables, particularly cardiac index, will be assessed before and after recruitment. Pulmonary effects will be evaluated using lung ultrasound atelectasis scoring and arterial blood gas analysis. The study aims to identify the recruitment strategy that provides optimal pulmonary benefits while preserving hemodynamic stability in this high-risk patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both the patients and the clinicians involved in perioperative management are blinded to group allocation. Outcome assessment and data analysis are performed by an investigator who is also blinded to group assignment.
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
- •Age 18-80 years
- •ASA (American Society of Anesthesiologists) II-IV
- •Patients undergoing elective cardiac surgery (coronary artery bypass grafting, mitral valve replacement, aortic valve replacement)
排除标准
- •Emergency surgery
- •Presence of perioperative arrhythmia
- •<35% left ventricular ejection fraction
- •>50 mmHg systolic pulmonary artery pressure
- •Known chronic obstructive pulmonary disease or interstitial lung disease
- •Pneumothorax
- •Mean arterial pressure <60 mmHg during recruitment maneuver
- •New York Heart Association (NYHA) class III-IV heart failure
- •Advanced cardiomyopathy or severe mitral regurgitation
- •Cross-clamp time longer than 2 hours
- •Requirement for high-dose inotropic or vasopressor support
- •Patients who cannot be extubated after postoperative 24 hours
研究组 & 干预措施
Grup Single Step
A single step lung recruitment maneuver for 30 seconds will be applied
干预措施: Single Step Lung Recruitment Maneuver (Procedure)
Grup Stepwise
A stepwise recruitment maneuver will be applied.
干预措施: Stepwise Lung Recruitment Maneuver (Procedure)
结局指标
主要结局
Change in Cardiac Index
时间窗: Intraoperative period
Difference in cardiac index measured before and after the lung recruitment maneuver.
次要结局
- The heart rate measurement(Intraoperative period and postoperative day 1.)
- The mean arterial pressure measurement(Intraoperative period and postoperative day 1.)
- Systemic vascular resistance index measurement(Intraoperative period and postoperative day 1.)
- Stroke volume variation(Intraoperative period and postoperative day 1.)
- Arterial elastance(Intraoperative period and postoperative day 1.)
- Contractility(Intraoperative period and postoperative day 1.)
- Lung ultrasound atelectasis score(Intraoperative period and postoperative day 1)
- Peak airway pressure(Intraoperative period and postoperative day 1.)
- Plateau pressure(Intraoperative period and postoperative day 1.)
- Dynamic lung compliance(Intraoperative period and postoperative day 1.)
- Driving pressure(Intraoperative period and postoperative day 1.)
- Positive end-expiratory pressure(Intraoperative period and postoperative day 1.)
- Arterial pH(Intraoperative period and postoperative day 1.)
- Partial pressure of arterial oxygen(Intraoperative period and postoperative day 1.)
- Partial pressure of arterial carbon dioxide(Intraoperative period and postoperative day 1.)
- Serum lactate level(Intraoperative period and postoperative day 1)
- Extubation time(Postoperative day 1)
- Length of intensive care unit stay (ICU)(The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days)
研究者
BURHAN DOST
Assoc. Prof.
Ondokuz Mayıs University