Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- cardia output measurement
研究概览
简要总结
Intraoperative hemodynamic optimization decreases postoperative complications and length of stay in high risk patient. Therefore, continuous monitoring of cardiac output (Qc) is recommended to guide fluid management. Thoracic bio-reactance is a recent technique that allows cardiac output non-invasive monitoring. However, additional clinical validation studies in humans are required to better define the typologies of patients for whom this monitoring could be proposed routinely. Lung surgery is defined as an intermediate or high risk surgery regarding postoperative cardiac complications. However, surgical patients rarely benefit from continuous monitoring of cardiac output, the available methods being considered too invasive or insufficiently reliable in daily practice. Thoracic bio-reactance (Non Invasive Cardiac Output Monitor (NICOM) Starling SV) has not been studied in this subgroup of clinically relevant patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Scheduled in Louis Pradel hospital operating theater (Lyon University Hospital) for elective Lung surgery (lobectomy, bilobectomy or pneumonectomy); by thoracotomy and / or thoracoscopy.
- •Having stated their non opposition to be part of this protocol
排除标准
- •Pregnant women ;
- •unemancipated minors;
- •Persons unable to express their consent;
- •Patients with contraindications to the placement of an oesophageal Doppler probe
- •Patients with suspicion of pathology or oesogastric lesion (dysphagia, diverticulum, stenosis ...)
- •Patients known for stage 2 or higher oesophageal varices
- •Patients with a history of significant mediastinal irradiation, or bariatric surgery.
- •Patients who have been treated in a therapeutic trial within 30 days of enrollment or who wish to participate in an ongoing study that may interfere with this study.
- •Persons benefiting from legal protection measures;
- •Patients unable to understand study objectives or refusing to comply with postoperative instructions
结局指标
主要结局
cardia output measurement
时间窗: Day 0
The primary endpoint is the accuracy of the cardiac output value measured with the NICOM Starling SV vs. oesophageal Doppler in thoracic controlled pulmonary exeresis surgery in adults. The accuracy considered valid and reliable will be defined as the error percentage for the Cardiac Output (CO) with an acceptability (concordance) threshold of 30 %. The accuracy will be evaluated on the totality of the time points of interrest. All data will be recorded at several time points interest (T0-T7) during surgery: * T0 Post Induction / supine position * T1 Lateral position closed Thorax / bipulmonary ventilation * T2 Lateral position closed Thorax / selective unipulmonary ventilation. * T3 Lateral position open Thorax * T4 pleural cavity being Washed * T5 Before Lung Recruitment Maneuver * T6 During Positive End Expiratory Pressure (PEEP) Standardized Pulmonary Recruitment Maneuver 30 cmH20 30 seconds * T7 End of Surgery / Awakening in lateral decubitus
次要结局
未报告次要终点