A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula)
2019年4月24日 更新者：University of California, San Francisco
A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula) Plus Nasal Cannula vs. Nasal Cannula Alone for Supplemental Oxygen Delivery in the Treatment of Hospitalized Pediatric Patients With Hypoxemia Due to Severe Pneumonia
This study evaluates the addition of a novel mask (nasal reservoir cannula) to a standard nasal cannula during supplemental oxygenation for the treatment of hospitalized pediatric patients with hypoxemia due to severe pneumonia.
Half of patients (Group A) will receive oxygen for 1 hour using a novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the standard nasal cannula delivery (Period 2).
Half of patients (Group B) will receive oxygen for 1 hour using a standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 2).
研究概览
详细说明
Pneumonia is the leading infectious cause of death among children less than 5 years of age. Hypoxemia is a major fatal complication of pneumonia, and the risk of death increases with increasing severity of hypoxemia. Improving oxygen delivery and extending oxygen supplies to children with hypoxemia due to severe pneumonia could reduce mortality in resource-limited settings.
Global Good has developed a low cost oxygen mask (nasal reservoir cannula) to more efficiently deliver oxygen to the pediatric patient by increasing dead space to recapture a portion of expelled oxygen using the spatial distribution of the nasal reservoir cannula volume and length of surface seal. This nasal reservoir cannula fits over a standard nasal cannula (also termed prong). The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
研究类型
介入性
注册 (实际的)
8
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
-
-
-
Kampala、乌干达
- Mulago Hospital
-
-
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
1年 至 6年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age ≥ 1 and ≤ 6 years.
- Severe pneumonia based on WHO criteria
- SpO2 ≥ 85% and < 94% by pulse oximetry on room air
- Hospital admission based on clinician judgment
- Written informed consent from parent(s)/guardian(s) of subjects must be obtained before any study procedure is performed
- Body weight ≥ 8 kg and ≤ 26 kg
Exclusion Criteria:
- Hypercapnia (pCO2 > 55 mm Hg or 7.32 kPa) on room air
- Acidosis / lactic acidosis (pH <7.20 and/or lactate >6 mg/dL) on room air
- SpO2 < 85% or ≥ 94% by pulse oximetry on room air
- SICK score > 2.4
- Hemoglobin < 7 g/dL
- Facial abnormalities or trauma precluding use of mask and nasal prongs.
- Requirement of intubation or non-invasive or invasive positive-pressure ventilation
- Suspected or known pneumothorax
- Body weight < 8 kg or > 26 kg
- Hemodynamic instability based on clinician judgment
- SpO2 < 90% by pulse oximetry on oxygen, measured at the end of the enrollment and before initiation of Period 1
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：设备可行性
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group A
Each patient will receive oxygen for 1 hour using a novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the standard nasal cannula alone (Period 2).
|
The experimental oxygen mask (nasal reservoir cannula) fits over a standard nasal cannula.
The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
|
|
实验性的：Group B
Each patient will receive oxygen for 1 hour using a standard nasal cannula alone (Period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 2).
|
The experimental oxygen mask (nasal reservoir cannula) fits over a standard nasal cannula.
The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
|
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 |
|---|---|---|
|
Recruitment rate
大体时间：1 hour
|
Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial.
|
1 hour
|
|
Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone)
大体时间：1 hour
|
Difference in volume of oxygen used, in liters (from cylinder) Estimation of effect size will help inform the design of a definitive clinical trial.
|
1 hour
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Protocol adherence
大体时间：2 hours
|
Proportion of enrolled children who completed the study, per protocol This will help inform the design of a definitive clinical trial.
|
2 hours
|
|
Oxygen flow
大体时间：1 hour
|
Average oxygen flow, in liters per minute
|
1 hour
|
|
Oxygen saturation (SpO2)
大体时间：1 hour
|
Average continuous oxygen saturation (SpO2) value
|
1 hour
|
|
PCO2
大体时间：End of each period
|
PCO2 (capillary blood gas)
|
End of each period
|
|
pH
大体时间：End of each period
|
pH (capillary blood gas)
|
End of each period
|
|
Transcutaneous carbon dioxide (tcpCO2)
大体时间：1 hour
|
Average continuous transcutaneous carbon dioxide (tcpCO2) value
|
1 hour
|
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。
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)
2017年9月1日
初级完成 (实际的)
2018年3月31日
研究完成 (实际的)
2018年3月31日
研究注册日期
首次提交
2018年3月2日
首先提交符合 QC 标准的
2019年4月24日
首次发布 (实际的)
2019年4月26日
研究记录更新
最后更新发布 (实际的)
2019年4月26日
上次提交的符合 QC 标准的更新
2019年4月24日
最后验证
2019年4月1日
更多信息
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.