Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Respiratory rate (RR)
研究概览
简要总结
The goal of this clinical trial is to clinically validate a system for the monitoring of patients' respiratory function and automated oxygen treatment proposal using non-invasive ventilation devices in the treatment of intensive care patients with acute or chronic lung diseases exacerbations. Participants clinical parameters will be monitored and samples will be sent to a clinical laboratory for analysis (arterial blood pressure, heart rate, and respiratory rate will be continuously recorded, and FeO2 and CO2 will be measured with the help of an additional sensor).
详细描述
This prospective experimental study is conducted in Pauls Stradins Clinical University Hospital (PSCUH) and Sleep Disease Center in Riga, Latvia. The study includes patients with respiratory failure and hypoxemia to whom NIV is indicated.
Participants clinical parameters are monitored and samples will be sent to a clinical laboratory for analysis.
Initial ventilation parameters will be defined by the clinician who performs the experiment.
During the validation phase, the investigators will obtain clinicians' final decision on the changes of the ventilation system parameters and compare it to our module proposal. That way it would be possible to estimate if the system is ready for the next step - fully automated closed-loop ventilation system development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent to participate in the study;
- •aged over 18 years;
- •patients hospitalized with acute respiratory failure (indication to NIV therapy) with restrictive or obstructive lung disease
排除标准
- •refusal to participate further in the study;
- •age under 18 years;
- •pregnancy;
- •the patient is contraindicated for non-invasive lung ventilation
- •during the study, the patients condition worsens in such a way that an active one is required medical intervention or continuation of the study may worsen the patients condition;
- •complications related to NIV therapy or claustrophobia;
- •chronic obstructive pulmonary disease and obstructive sleep apnea without documented hypoxemia (Sp02 and Sa02 > 94%).
结局指标
主要结局
Respiratory rate (RR)
时间窗: 11 months
Evaluation will include the difference in the respiratory rate (xmin) measures pre-interventionally and during the intervention.
Apnea-Hypopnea Index (AHI)
时间窗: 11 months
The change in the Apnea-Hypopnea Index (AHI) within oxygen titration will be measured pre-interventionally and during the intervention.
Transcutaneous CO2 partial pressure (tcCO2)
时间窗: 11 months
The change in transcutaneous CO2 partial pressure (mmHg) within oxygen titration and the time spent within an acceptable CO2-interval measured pre-interventionally and during the intervention.
Blood Oxygen Saturation (SpO2)
时间窗: 11 months
Evaluation will include the difference in blood Oxygen Saturation (SpO2%) pre-interventionally and during the intervention.
Upper airway Carbon dioxide levels (CO2)
时间窗: 11 months
The change in CO2 (mmHg) within oxygen titration will be measured pre-interventionally and during the intervention.
Blood pressure (TA)
时间窗: 11 months
Evaluation will include the difference in the blood pressure (mmHg) measures pre-interventionally and during the intervention.
Heart rate (HR),
时间窗: 11 months
Evaluation will include the difference in the heart rate (xmin) pre-interventionally and during the intervention.
次要结局
- adverse events description(11 months)