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临床试验/NCT06621641
NCT06621641已完成不适用

Outcomes of a Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Critical Bronchiolitis Patients

Dr. Behcet Uz Children's Hospital9 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
9
主要终点
HFNC duration

研究概览

简要总结

Bronchiolitis is a leading cause of pediatric hospital admissions. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing.

Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy.

This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Children's Hospital, involving infants aged 1-24 months admitted with bronchiolitis.

详细描述

Bronchiolitis is a leading cause of pediatric hospital admissions. While high-flow nasal cannula (HFNC) is effective as a rescue therapy for patients with severe respiratory distress when standard oxygen therapy fails, studies suggest that early use of HFNC in moderate cases does not significantly improve outcomes such as hospital stay duration or intubation rates. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing, raising concerns about unnecessary treatment and extended hospital stays due to a lack of standardized weaning protocols.

Evidence suggests that HFNC should be used effectively as a rescue treatment after standard oxygen therapy fails, serving as an intermediate step before invasive support. However, the high costs and self-limiting nature of bronchiolitis necessitate reducing the overuse of HFNC in hospitalized children. Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy.

This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Children's Hospital, involving infants aged 1-24 months admitted with bronchiolitis. A multidisciplinary team will evaluate patients using the Respiratory Assessment Scale (RAS), with mild, moderate, and severe classifications. The study compares HFNC duration, hospital stay, oxygen support duration, and associated costs before and after the protocol implementation.

Exclusion Criteria:

Premature infants born at less than 32 weeks Patients with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities were excluded.

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
None

入排标准

年龄范围
1 Month 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients older than 1 month and younger than 24 months of age; hospitalized at the PICU with the intention of treatment with HFNC at least for the upcoming 4 hours
  • Patients with moderate and severe RAS(Respiratory Assessment Scale) requiring HFNC
  • 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

排除标准

  • İnfants born before 32 weeks of gestation or those with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities.
  • Patient with an indication for immediate noninvasive ventilation (NIV)
  • Patients deemed at high risk for the need for non-invasive mechanical ventilation within the next 4 hours
  • Hemodynamic instability

结局指标

主要结局

HFNC duration

时间窗: Through study completion, an average of 1 year

HFNC duration calculated during intensive care hospitalization

Hospital length of stay

时间窗: Through study completion, an average of 1 year

Total hospital stay time including intensive care unit

Need for non-invasive ventilation

时间窗: Through study completion, an average of 1 year

It will be compared whether there is a difference between the two groups in terms of niv needs.

Associated costs

时间窗: Through study completion, an average of 1 year

HFNC costs and total hospitalization costs will be calculated

次要结局

未报告次要终点

研究者

发起方
Dr. Behcet Uz Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasan ağın

Prof. Doctor

Dr. Behcet Uz Children's Hospital

研究点 (9)

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