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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Nasal reservoir cannula (Device)
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).
干预措施: Nasal reservoir cannula (Device)
结局指标
主要结局
Recruitment rate
时间窗: 1 hour
Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial.
Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone)
时间窗: 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.
次要结局
- Protocol adherence(2 hours)
- Oxygen flow(1 hour)
- Oxygen saturation (SpO2)(1 hour)
- pH(End of each period)
- Transcutaneous carbon dioxide (tcpCO2)(1 hour)
- PCO2(End of each period)