Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring Vs End-tidal Partial Pressure Carbon Dioxide (PetCO2) Measurement in the Diagnosis of Hyperventilation Syndrome (HVS) (TCvsPETCO2 )
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Trans-cutaneous Carbon Dioxide pressure
研究概览
简要总结
Hyper Ventilation Syndrome is a frequent disease affecting adults whose diagnosis is often belated or even unrecognized due to the lack of "gold standard" criteria. Its diagnosis currently relies on the Nijmegen score associated with a PetCO2 assesment using a hyperventilation provocation test. Correlation between Nijmegen Questionnaire scores and PetCO2 appears highly variable. PtcCO2 monitoring is a noninvasive alternative method providing a continuous estimation of arterial CO2 pressure (PaCO2) which could represent an advantageous alternative to PetCO2 measurements. Several reports have demonstrated that PtcCO2 monitoring reflects more faithfully PaCO2 than PetCO2, no study have evaluated its value in this indication.
The primary aim of the study is to compare the diagnostic value of PtcPCO2 monitoring with PetCO2, the method currently used.
Included patient will be invited to fill in the Nijmegen questionnaire and an ambient air gas measurement will be performed. PtcCO2 (mmHg) will be simultaneously measured during hyperventilation test. Nijmegen score signs reproduced by the test will be analysed. HVS diagnosis will be assessed by usual criteria (PetCO2 <30 mmHg at the end of hyperventilation test or under the PetCO2 value at rest, Nijmegen score> 23).
PtcCO2 data will be blinded interpreted later. We will compare if PetCO2 and PtcCO2 leads to the same diagnosis or not.
详细描述
Primary Goal:
Show that the use of either of the two pCO2 measurements leads to the same diagnostic conclusion in HVS diagnosis with a likelihood greater than 80 %.
Secondary Outcome Measures :
Evaluate the correlation between PtcCO2 and PtcCO2 measurements Evaluate tolerance to the hyperventilation test
Inclusion Criteria :
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have reached the age of the civil majority (≥ 18 yo)
- •All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test
- •The patient must be a member or beneficiary of a health insurance program
- •The patient must have given his / her free and informed consent and signed the consent
排除标准
- •Hypercapnia (PaCO2 > 50mmHg)
- •Patient treated by long-term oxygen therapy
- •Subjects under judicial protection, or adults under any kind of guardianship or under judicial control
- •Pregnancy or breastfeeding women
- •Electrolytic unbalance
- •Hyperthyroidism
- •Neurological disease
- •Probability of drug-induced hyperventilation (progestagens , aspirin, beta agonists)
结局指标
主要结局
Trans-cutaneous Carbon Dioxide pressure
时间窗: during hyperventilation test
Trans-cutaneous Carbon Dioxide pressure measurements diagnostic of hyperventilation syndrome will be evaluated by comparing it with that of standard
End-tidal Carbon Dioxide partial pressure
时间窗: during hyperventilation test
End-tidal Carbon Dioxide partial pressure measurement. Consistency of the diagnostic conclusions reached by either test will be analyzed.
次要结局
未报告次要终点