NCT03816514已完成不适用
Use of Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range During Major Surgery: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- The incidence of deviation from the target hemoglobin range
研究概览
简要总结
The primary aim of this study is to evaluate whether pulse oximetry based noninvasive hemoglobin (SpHb) monitoring can reduce the incidence of hemoglobin (Hb) level out of the target range in adult patients undergoing major surgery with the potential risk of bleeding.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with ASA physical status class I, II, III, who scheduled to undergo elective non-cardiac major surgery with more than moderate risk of bleeding under general anesthesia or spinal anesthesia.
- •Eligible Surgery include: Spine surgery, bone tumor surgery, Total Hip Replacement, ovarian cancer surgery, cervical cancer surgery, radical cystectomy, open retroperitoneal mass excision, Radical Retropubic Prostatectomy, explorative laparotomy for abdominal mass excision, abdominal aortic aneurysm repair
- •Patients who are requiring an arterial catheter as a part of their standard care.
排除标准
- •Patients with preexisting deformity or skin condition that would impede sensor placement
- •Patients with allergies to the adhesive sensor material
- •Patients with uncorrected preoperative anemia (preoperative hemoglobin < 7 g/dL)
- •Patients who were not suitable for participation in the opinion of the study investigator.
结局指标
主要结局
The incidence of deviation from the target hemoglobin range
时间窗: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
(The number of laboratory samples with the result hemoglobin concentrations were out of the target range)/(Total number of laboratory samples that performed during intra-operative periods)
次要结局
- The percentage extent of deviation from the target hemoglobin range(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
- Number of Point-of-care (POC) sampling during surgery(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
- Total volume of intravenous fluids given(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
- Accuracy of the SpHb value(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
- Number of patients who receive intra-operative transfusion(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
- Total volume of pRBCs transfused(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
- Time for transfusion delay(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
- Incidence of intraoperative hypotension(Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia)
- laboratory total hemoglobin value, at postoperative day 1(at postoperative day 1)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital
研究点 (2)
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