Evaluation of AGM100 Pulmonary Gas Exchange Monitor in Clinical Use
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The sample size was calculated based on the primary outcome of agreement between non-invasive estimation of arterial oxygen partial pressure(PaO2) obtained using AGM100 and PO2 measures by Arterial Blood Gas(ABG) analysis.Assuming acceptable limits of agreement of +-10 mmHg,a 95% confidence level, and adequate precision for Bland-Altman analysis,the minimum required sample size was calculated to be 30 participants,accounting for measurement variabillity and technical exclusion.
研究概览
简要总结
The study evaluates the AGM100 Pulmonary Gas Exchange Monitor, a novel non-invasive device designed to assess gas exchange efficiency at the bedside The AGM100 estimates variables such as Oxygen Deficit and estimated arterial oxygen pressure PaO2 by analyzing end-tidal CO2 and oxygen saturation, providing real time insights into pulmonary function without the need for arterial blood gas sampling.
This technology is particularly valuable in managing patients with non-ventilated respiratory conditions such as COVID 19, pneumonia, and chronic obstructive pulmonary disease COPD. These patients often experience impaired oxygenation due to ventilation-perfusion mismatch or diffusion abnormalities. The AGM100 enables clinicians to detect these gas exchange deficits early, helping guide oxygen therapy and escalation of care decisions.
In COVID 19 and pneumonia, where patients may appear clinically stable despite underlying hypoxemia silent hypoxia the AGM100 offers a non-invasive method to track deterioration. In COPD patients, it assists in evaluating the effectiveness of bronchodilators, supplemental oxygen, or identifying exacerbations without invasive monitoring.
Clinicians reported that the AGM100 is easy to use and integrates well into clinical workflows, offering a promising tool for enhancing patient care in both acute and chronic respiratory conditions.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy volunteers and patients with specific conditions like Pneumonia and COPD patient Willingness to provide informed consent.
排除标准
- •Pregnant individuals Participants with implanted electronic medical devices Severe skin conditions interfering with sensor application.
结局指标
主要结局
The sample size was calculated based on the primary outcome of agreement between non-invasive estimation of arterial oxygen partial pressure(PaO2) obtained using AGM100 and PO2 measures by Arterial Blood Gas(ABG) analysis.Assuming acceptable limits of agreement of +-10 mmHg,a 95% confidence level, and adequate precision for Bland-Altman analysis,the minimum required sample size was calculated to be 30 participants,accounting for measurement variabillity and technical exclusion.
时间窗: Single time point with simultaneous measurement of non-invasive PaO2 using AGM100 and PO2 measured by Arterial Blood Gas(ABG) during the same clinical encounter.
次要结局
- Secondary outcomes include assessment of correlation between non-invasive arterial oxygen partial pressure(PaO2) estimated using AGM100 & PO2 measured by Arterial Blood Gas (ABG) analysis,evaluation of measuremen bias across different levels of oxygenation,assessment of variability in PaO2 differences & feasibility of obtaining non-invasive measurements during routine clinical assessment.(Single time point assessed concurrently with the primary outcome,with non invasive PaO2 measurement using AGM100 & Po2 measured by ABG during same clinical encounter)
研究者
Dr Vijay Kumar Chennamchetty
Apollo Hospitals Jubilee Hills Hyderabad