NCT05912543已完成不适用
A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index (ORi™) During One-lung Ventilation in the Pediatric Patient: 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
- 70
- 试验地点
- 2
- 主要终点
- The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)
研究概览
简要总结
The purpose of this prospective randomized controlled trial is to determine whether using the Oxygen Reserve Index can prevent hyperoxemia in pediatric patients receiving single-lung ventilation.
Participants will have their FiO2 adjusted in a prescribed manner based on the arm to which they are assigned.
The researchers will compare whether blood oxygen levels were lower in the ORI group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 7 years of age undergoing surgery under unilateral pulmonary ventilation
- •Children with American Society of Anesthesiology physical status I, II, III
排除标准
- •Patient who have chronic respiratory failure
- •Patient who have a history of bronchopulmonary dysplasia, respiratory distress syndrome of neonate, laryngomalacia, tracheomalacia or tracheal stenosis
- •Patient whose initial Oxygen Reserve Index value is zero
- •Patient who need supplementary oxygen before surgery
结局指标
主要结局
The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)
时间窗: 30 minutes after initiation of one-lung ventilation
arterial oxygen content over 200
次要结局
- time-weighted average inspired oxygen fraction(during one lung ventilation)
- incidence of perioperative complications(perioperative period)
- incidence of hypoxemia(perioperative period)
- average Oxygen Reserve Index value(during one lung ventilation)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE)Pulmonary EmbolismNCT04003116Ministry of Health, Spain70
已完成
3 期
Inhaled Nitrous Oxide for Pain Relief During Eye Exam in the Pre-term InfantRetinopathy of PrematurityNCT00623220Nabeel Ali40
已完成
3 期
The Role of Oxygen in the Management of Dyspnoea in Advanced CancerCancerNCT00206609Bayside Health50
尚未招募
不适用
Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseInterstitial Lung DiseaseNCT06767904Sissel Kronborg-White60
已完成
不适用
Oxygen Reserve Index in Airway Surgery in ChildrenHypoxemia During SurgeryNCT05214950Seoul National University Hospital88