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临床试验/NCT04895332
NCT04895332撤回不适用

BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation

Charite University, Berlin, Germany0 个研究点开始时间: 2021年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
BPOI (Berlin Pediatric Oxygenation Index)

研究概览

简要总结

The investigators developed an index that integrates different flow-settings in High-flow nasal cannula (HFNC) therapy with non-invasively measured clinical parameters of oxygenation in pediatric patients. This observational study is designed to evaluate this index and to determine a cut-off value for imminent HFNC failure.

详细描述

High-flow nasal cannula therapy is a broadly used instrument of respiratory support in pediatric and adult patients with respiratory failure.

For adult patients with pneumonia and respiratory failure, there is a validated index (ROX; ratio SpO2/FiO2) which helps to identify those at risks for the need of intubation.

This index however is not applicable in the pediatric population because the physiological values of respiratory rate vary greatly across different ages.

Thus, based on the particularities of pediatric patients the investigators developed an index that integrates different flow-settings in HFNC therapy with non-invasively measured clinical parameters of oxygenation. The BPOI is defined as the ratio of the product of the peripherally measured oxygen saturation and the patient's body weight divided by the product of HFNC flow and the fraction of inspired oxygen:

BPOI = (SpO2 * kg) / (Flow * FiO2)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
28 Days 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with respiratory failure and indication für High-flow nasal cannula therapy
  • Patients aged between 4 1/7 weeks and 18 years
  • Patients who were treated between 01/01/2017 and 28/02/2021 in the Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine at Campus Virchow- Klinikum, Charité - Universitätsmedizin Berlin

排除标准

  • Patients aged between 1 and 27 days (neonatal period)
  • Patients with congenital cyanotic heart defects
  • Patients after or in the course of haematopoetic stem cell transplantation
  • Patients with ambulatory respiratory support

结局指标

主要结局

BPOI (Berlin Pediatric Oxygenation Index)

时间窗: 01.01.2017-28.02.2021

Evaluation of a certain cut-off value for the BPOI (Berlin Pediatric Oxygenation Index) that predicts imminent failure of high-flow nasal cannula (HFNC) therapy in paediatric patients.

次要结局

  • Intensive care unit length of stay(01.01.2017-28.02.2021)
  • Blood pressure (mean arterial pressure, MAP)(01.01.2017-28.02.2021)
  • Need for intubation(01.01.2017-28.02.2021)
  • Heart rate(01.01.2017-28.02.2021)
  • Respiratory rate(01.01.2017-28.02.2021)
  • High-flow nasal cannula therapy failure(01.01.2017-28.02.2021)
  • Need for mechanical ventilation(01.01.2017-28.02.2021)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Spies

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Charite University, Berlin, Germany

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