Monitoring of the End-tidal Carbon Dioxide (EtCO2 ) as a Severity Criterion in COPD Exacerbations: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Invasive or non-invasive ventilation (NIV) use (hour/min)
研究概览
简要总结
Although we know that these numbers are underestimated, Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease that affects between 8 and 12% of adults. According to a 2020 WHO report, it is the third most common cause of mortality in developed countries. This disease is punctuated by exacerbations associated with an 8% mortality of hospitalized patients, increased to 24% when the patient is admitted to intensive care unit. Early detection and treatment of these exacerbations appears to be essential to improve patient survival. End-tidal carbon dioxide (EtCO2) is used to assess a patient's respiratory and hemodynamic status. Indeed, EtCO2 is a non-invasive measure that could allow the estimation of arterial carbon dioxide (PaCO2) without performing blood gases, an arterial blood sampling, classically at the radial artery. This study aimed to find an EtCO2 value which at the time of the initial management, would be predictive of a severe COPD exacerbation, as well as PaCO2.
详细描述
The study will be conducted in the emergency departments of Grenoble and Lyon University Hospitals.
Patients will be recruited by the dispatch nurse at the emergency department reception according to the inclusion and non-inclusion criteria. The EtCO2 will be measured at the emergency reception during assessment of vital signs by the same nurse with the help of a mask or oxygen glasses measuring EtCO2. The patient will then be treated conventionally according to current international recommendations. The physician in charge of the patient will be blinded to this measurement. Once the patient is discharged from the emergency department, the primary and secondary endpoints will be collected by a clinical research associate 24 hours after admission from medical record.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •All patient presenting to the emergency department with acute dyspnea and with a history of COPD documented or reported by the patient and/or family
- •Male or female≥18 years old who did not oppose to participating in the study
排除标准
- •Hypotension (SBP < 90 mmHg or MBP < 65 mmHg)
- •Patient already included in the study during a previous visit to the emergency department
- •Patient already ventilated with invasive or NIV during admission to the emergency department
- •COPD exacerbation rejected after medical and additional examinations
- •Non-communicative or non-French speaking patients, or with impaired comprehension, or with impaired consciousness
- •Protected persons referred to in articles L1121-6 and L1121-8 of French public health code (deprived of liberty, tutorship or curatorship)
研究组 & 干预措施
Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease
Patient admitted for acute Exacerbation of COPD. The measurement of EtCO2 will be performed at the emergency department
干预措施: End-Tidal CO2 measurement during COPD exacerbation (Diagnostic Test)
结局指标
主要结局
Invasive or non-invasive ventilation (NIV) use (hour/min)
时间窗: 24 hours
Invasive or non-invasive ventilation (NIV) use (hour/min)
次要结局
- Arterial Blood Gaz measurement(15 minutes (after emergency admission))
- Concordance between EtCO2 (mmHg) and PaCO2 (mmHg) using Bland and Altman graphical method.(15 minutes (after emergency admission))
- Concordance between EtCO2 (mmHg) and PvCO2 (mmHg) using Bland and Altman graphical method.(15 minutes (after emergency admission))