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Closed-loop Oxygen Control for High Flow Nasal Therapy (HILOOP)

Safety and Efficacy of a Closed-loop Oxygen Control for High Flow Nasal Therapy in ICU Patients: a Randomized Cross-over Study (The HILOOP Study)

In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decrease work of breathing as compared to standard oxygen therapy by facemask. Current guidelines recommend adjusting oxygen flow rates to keep the oxygen saturation measured by pulse oximetry (SpO2) in the target range and avoid hypoxemia and hyperoxemia. The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ICU patients treated with HFNT.

研究概览

研究类型

介入性

注册 (实际的)

53

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult (>17yo) patients admitted to the ICU treated with HFNT for at least 8h
  • Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician
  • Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation.

Exclusion Criteria:

  • Patient with indication for immediate continuous positive airway pressure (CPAP), noninvasive ventilation (NIV), or invasive mechanical ventilation
  • Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
  • Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange colour bar)
  • Severe acidosis (pH ≤ 7.30)
  • Pregnant woman
  • Patients deemed at high risk for need of mechanical ventilation within the next 8 hours
  • Chronic or acute dyshemoglobinemia: methemoglobin, carbon monoxide (CO) poisoning, sickle cell disease
  • Tracheotomised patient
  • Formalized ethical decision to withhold or withdraw life support
  • Patient under guardianship
  • Patient deprived of liberties
  • Patient included in another interventional research study under consent
  • Patient already enrolled in the present study in a previous episode of acute respiratory failure

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Oxygen close-loop
Four hours period where the fraction of inspired oxygen delivered will be automatically titrated based on SpO2 values.
The Automatic FiO2 option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the Oxygen setting to keep the patient's SpO2 in the target range.
有源比较器:Manual FiO2 adjustment
Four hours period where the fraction of inspired oxygen delivered will be manually adjusted by the healthcare personnel based on SpO2 values.
Manual FiO2 adjustment according to SpO2 values

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of time spent in optimal SpO2 range
大体时间:4 hours
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
4 hours

次要结果测量

结果测量
措施说明
大体时间
Percentage of time spent in sub-optimal SpO2 range
大体时间:4 hours
SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
4 hours
Percentage of time spent out of range
大体时间:4 hours
Above or below the suboptimal limits specified at the begginning of the study
4 hours
Percentage of time with SpO2 signal available
大体时间:4 hours
Time with SpO2 signal available
4 hours
Mean SpO2/FiO2
大体时间:4 hours
Mean oxygenation value
4 hours
ROX index
大体时间:4 hours
Is a predictor of HFNT success/failure defined as (SpO2/FiO2)/respiratory rate
4 hours
Percentage of time with SpO2 below 88 and 85 percent
大体时间:4 hours
Duration of time with SpO2 <85 percent and <88 percent, respectively
4 hours
Number of events with SpO2 below 88 and 85 percent
大体时间:4 hours
Frequency of SpO2 decreases <85 percent and <88 percent, respectively
4 hours
Mean FiO2
大体时间:4 hours
Mean fraction of inspired oxygen
4 hours
Percentage of time with FiO2 below 40 percent and above 60%
大体时间:4 hours
Percentage of time that FiO2 is <40 percent and >60 percent, respectively
4 hours
Number of manual adjustments
大体时间:4 hours
Frequency of manual adjustments of FiO2
4 hours
Number of alarms
大体时间:4 hours
Frequency of alarms
4 hours
Patient comfort
大体时间:4 hours
Comfort score by visual analogic scale (from 0 to 10)
4 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月27日

初级完成 (实际的)

2021年8月10日

研究完成 (实际的)

2021年8月10日

研究注册日期

首次提交

2021年5月4日

首先提交符合 QC 标准的

2021年7月7日

首次发布 (实际的)

2021年7月16日

研究记录更新

最后更新发布 (实际的)

2021年12月9日

上次提交的符合 QC 标准的更新

2021年11月26日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Oxygen close-loop的临床试验

3
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