NCT01743105已完成不适用
Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Diaphragmatic excursion, first measure by investigator 1
研究概览
简要总结
The main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.
详细描述
The secondary objectives of this study are:
- To assess the feasibility of measuring the diaphragmatic excursion in the context of emergency management (ratio of measured patients / included patients).
- To evaluate the time required for the measurement.
- To assess the intra-rater reproducibility of measurements of diaphragmatic excursion (comparison of first and second measures).
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
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient has acute respiratory distress defined by a respiratory rate > 25, and / or signs of struggle and hypoxia, oxygen saturation (SpO2) <90% and / or pH <7.35 and carbon dioxide partial pressure (pCO2) > 6 kPa (45 mm Hg)
- •The patient breathes spontaneously (no respirator)
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient or his/her representative refuses to sign the consent
- •It is impossible to correctly inform the patient, or to correctly inform his/her representative
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a neurological or neuromuscular disease that modifies diaphragm function/movement; this does not include cases of decompensation (polyradiculoneuropathy, Lou Gehrig's disease, Myasthenia ...).
- •Patient admitted with respiratory support treatment in progress
- •Patient admitted with respiratory failure requiring immediate implementation of mechanical ventilation, thus preventing ultrasound measurements
结局指标
主要结局
Diaphragmatic excursion, first measure by investigator 1
时间窗: Baseline (day 0)
in centimeters
Diaphragmatic excursion, first measure by investigator 2
时间窗: Baseline (day 0)
in centimeters
次要结局
- Feasibility (yes/no)(Baseline (day 0))
- Diaphragmatic excursion, second measure by investigator 2(Baseline (day 0))
- Time necessary to measure diaphragm movement amplitude (minutes)(Baseline (day 0))
- Diaphragmatic excursion, second measure by investigator 1(Baseline (day 0))
研究者
研究点 (2)
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