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临床试验/NCT03689686
NCT03689686Unknown不适用

Physiological Effects of High Flow Nasal Cannulas Oxygen Therapy vs Continuous Positive Airway Pressure in Pediatric Acute Respiratory Failure

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Changes in respiratory work of breathing for each study trial

研究概览

简要总结

Non-invasive Continuous Positive Airway Pressure (nCPAP) is widely recognized as an efficient respiratory support in infants with mild to moderate Acute Hypoxemic Respiratory Failure (AHRF).

Its application results in alveolar recruitment, inflation of collapsed alveoli, and reduction of intrapulmonary shunt. nCPAP is traditionally delivered with nasal prongs, nasal/facial mask. CPAP by helmet was introduced more recently in the clinical practice.

The helmet circuit was described in details in previously published studies. From a physiological point of view the helmet circuit could be considered the best system to deliver CPAP because of the following: 1) it is characterized by the lowest amount of leaks around the interface and mouth opening 2) airways are free from potentially obstructing devices (cannula) thus the resistance is minimized and 3) theoretically the pressure is more stable minimizing the leaks 4) it is comfortable and usually sedation is not needed.

High Flow Nasal Cannula (HFNC) is increasing in use both in adults and pediatric population. HFNC could result in several clinical benefits by reducing inspiratory effort and work of breathing, increasing end-expiratory volume and CO2 wash-out for upper airways and creating a CPAP effects of 2-3 cmH2Oin the upper airways. This CPAP effect combined with an increase in CO2 wash-out and optimal airways humidification could decrease the respiratory work of breathing and improve gas exchange. However little is known about the optimal flow rate setting to improve the respiratory mechanics and gas exchange. Recent studies have reported that HFNC in nonintubated children improves oxygenation, reduces the respiratory drive and prevent reintubation in high patient risk. However all these physiological effects during HFNC therapy are only speculative.

To address the question on the more efficient devices to support the child in the early phase of mild to moderate AHRF, the Authors designed a physiological randomized crossover study aimed at measuring the physiological effects of HFNC 2 and 3 l/Kg and helmet CPAP on the work of breathing (estimated by the esophageal Pressure Time Product, PTPes) in pediatric AHRF.

详细描述

Primary end point of the study is the variation in esophageal Pressure Time Product (PTPes) across the trials of HFNC at different flow rates (2and 3 l/kg/min) and CPAP by helmet.

Study design

Physiological crossover prospective study comparing three study trials (20 mins) delivered in computer generated random order:

1- HFNC flow 2l/Kg; 2- HFNC flow 3l/Kg; 3- Helmet CPAP (fresh gas flow 35 l/min, CPAP 6 cmH2O)

Four 20 mins wash out period between trials are imposed to avoid the carry over effect one treatment on the following.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Days 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • P/F<300 with oxygen mask (FiO2=0.4) for 15 minutes plus two of the followings:
  • Respiratory Rate (RR)>2SD according to age
  • Active contraction of respiratory muscles
  • Paradoxical abdominal motion

排除标准

  • Emergency need for intubation
  • Glasgow Coma Scale <12
  • Hypercapnia with pH <7.25
  • Cough reflex impairment
  • Upper-airway obstruction
  • Facial/gastric surgery
  • Recurrent apnoeas
  • Hemodynamic instability (need for vasopressor or inotropes)
  • Pneumothorax on lung echo or chest x ray
  • esophageal surgery.

研究组 & 干预措施

Patients

Experimental

Fifteeen children with Acute Respiratory Failure admitted to a PICU, needing noninvasive respiratory support

干预措施: Noninvasive Respiratory Support (Device)

结局指标

主要结局

Changes in respiratory work of breathing for each study trial

时间窗: The last three minutes for each study trial

Esophageal Pressure Time Product

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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