跳至主要内容
临床试验/NCT06425107
NCT06425107招募中不适用

Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection

Vittore Buzzi Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Lung Ultrasound findings associated with failure of noninvasive ICU-LRS (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI.

研究概览

简要总结

Prospective, observational multicentric study which aims at identifying lung POCUS (Point of Care UltraSound) findings associated with failure of noninvasive ICU-LRS (Intensive Care Unit Level Respiratory Support) (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI (Low Respiratory Tract Infection) and at identifying lung, pleural, and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later.

详细描述

Lower respiratory tract infections, primarily viral bronchiolitis, are a common cause of PICU admission for infants. While overall hospitalization rates for bronchiolitis are declining, ICU admission rates are actually increasing. The trend in respiratory management of critically ill infants with LRTIs has shifted from frequent invasive mechanical ventilation to more common use of non-invasive modalities, including CPAP, BiPap, and HFNC. Currently, the overwhelming majority of infants requiring ICU-level respiratory support (ICU-LRS) for bronchiolitis receive only noninvasive support.

During the past decade, point-of-care lung ultrasound (POCUS) is increasingly being used in both adults and children to enhance diagnostic and prognostic ability in respiratory failure. Lung POCUS is appealing due to the lack of radiation exposure compared to x-rays, the added sensitivity and specificity that it can add compared to traditional imaging to help differentiate consolidation from atelectasis from edema (may all have similar appearance on x-rays), the dynamic nature of the study to evaluate the lung parenchyma, pleura, and diaphragm, and the fact that it can be easily applied and repeated at the bedside to guide adjustments to therapies and evaluate their response. Lung POCUS differs from traditional radiology-based lung ultrasound in that it is focused and goal-directed, is frequently performed serially by the clinician managing the patient at the bedside, and is frequently used to immediately direct care decisions in real-time.

While lung POCUS is quickly becoming a standard of care for adults with respiratory failure, pediatric data, particularly in critically ill infants with bronchiolitis and other lower respiratory tract infections (LRTI) is largely lacking. Investigators from some sites within the BACON research group have begun to evaluate the role of lung POCUS in infants with bronchiolitis. These studies have primarily focused on the emergency department, but they have identified POCUS findings that are associated with clinical deterioration and have developed a pediatric lung ultrasound score that can predict infants who will require ICU-LRS. There are only two pediatric ICU bronchiolitis studies-one looking at the lung/pleura but in invasively ventilated patients only, and the other focused on the diaphragm in patients requiring noninvasive support.

Unfortunately, there are minimal data on infants in the ICU with bronchiolitis, and all of these prior studies are limited by low sample size. Thus, there is a significant knowledge gap about the ability of lung POCUS and these previously identified findings and scoring systems to accurately predict failure of noninvasive ICU-LRS for infants in the ICU with bronchiolitis and other LRTIs. Furthermore, there are no data evaluating the role of lung POCUS in identifying patients who will have a favorable response to adjustments in ICU-LRS settings.

Endpoints of the study are:

研究设计

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

入排标准

年龄范围
0 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age <1 year at the time of hospital admission
  • Admission to PICU for suspected/confirmed LRTI
  • Treatment (within the 1st 12 hours of ICU stay) with noninvasive ICU-LRS for respiratory failure (HFNC >1L/kg/min, negative pressure, or noninvasive PPV via any interface (CPAP, BiPap, NIMV, etc.)

排除标准

  • Invasive ventilation as initial support or within the 1st 12 hours of ICU stay, either via endotracheal tube or tracheostomy
  • Upper respiratory symptoms only (stridor, stertor)
  • Corrected gestational age <37 weeks at time of ICU admission
  • ICU-LRS for only nonrespiratory reasons (e.g. shock) or for pulmonary edema felt to be solely due to noninfectious causes (cardiogenic, airway obstruction, drowning). Patients presenting with apnea can be included if they have a diagnosis of bronchiolitis or other LRTI
  • Prior inclusion in the study

结局指标

主要结局

Lung Ultrasound findings associated with failure of noninvasive ICU-LRS (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI.

时间窗: First 24 hours after ICU admission

Ultrasound findings will be graded according to the scale proposed by the Italian Academy of thoracic Ultrasound: 0: normal A lines 1. short vertical artifacts and isolated B lines 2. multiple B lines (B lines with a distance of less than half centimeter to the confluence, remaining identifiable from each other) 3. white lung (subpleural field with various shades of grey/white without distinguishing B lines) and subpleural consolidations smaller than 1 cm 4. subpleural consolidations bigger than 1 cm

次要结局

未报告次要终点

研究者

发起方
Vittore Buzzi Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Camporesi

Principal Investigator

Vittore Buzzi Children's Hospital

研究点 (1)

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