Impact of the Non-invasive Oxygen-reserve-index (ORI) Versus Standard of Care on Peripheral Oxygen Saturation (SpO2) During Endotracheal Intubation (ETI) in Intensive Care Unit: Randomised Superiority Multi-center 2 Arms, Open Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 950
- 试验地点
- 42
- 主要终点
- Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI
研究概览
简要总结
The purpose of this study is to determine whether ORI monitoring increases the lowest oxygen saturation level during the interval between the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) and the end of the second minute after successful ETI.
详细描述
The trial population will be adults (18 years of age or older) who need endotracheal intubation while hospitalized in ICU
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
- Single (Investigator)
盲法说明
During intubation procedure, blinded continuous monitoring of SpO2 and ORI (for control group) will be performed by appropriate monitor (Masimo Rad7) with data extraction at regular intervals.
Oxygen saturation will be tracked during ETI by research nurse or assistant nurse dedicated to fill the eCRF. ORI evolution will not be provided to investigators in the standard of care group.
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
- •ICU admission and need for ETI to allow mechanical ventilation
- •Need for supplemental oxygen (via any device and at any flow rate) to obtain SpO2>97%
- •Patient or next of kin informed about the study and having consented to participation of the patient in the study (patients with coma are unable to consent). If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law
- •Patients affiliated to a social security system
排除标准
- •Patients participating in intubation research with an oxygenation endpoint will not be eligible for inclusion
- •Fiberoptic intubation required according to physician in charge
- •Contra-indications to laryngoscopy (e.g., unstable spinal lesion)
- •Insufficient time to include and randomise the patient (e.g., because of cardiac arrest)
- •Age <18 years
- •Currently pregnant or breastfeeding
- •Correctional facility inmate
- •Under guardianship, curatorship or under protection of justice
结局指标
主要结局
Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI
时间窗: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Experimental and Control groups
次要结局
- Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter.(From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI)
- Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Body Mass Index (<30 or ≥30)" subgroup(From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI)