NCT06008587终止不适用
Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer6 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2024年2月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Failure of the Nasal High Flow
研究概览
简要总结
The hypothesis is that Nasal High Flow therapy for patients with Hypercapnic Acute Respiratory Failure without acidosis, in addition to standard treatment would improve the care.
详细描述
The aim of the PIRAHNA study is to compare patients treated with Nasal High Flow in association with conventional standard treatment versus patients treated only with conventional standard treatment.
Primary objective : To demonstrate the therapeutic superiority of Nasal High Flow in hypercapnic Acute Respiratory Failure without acidosis, in combination with conventional standard treatment
Secondary objectives :
- Identify the characteristics (etiologies) of responder patients (defined by a decrease in capnia and a failure to develop acidosis within two weeks of hospitalization)
- Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients
- Compare the evolution of respiratory rate between the two treatment groups
- Compare the evolution of dyspnea between the two treatment groups
- Compare the evolution of gas exchanges between the two treatment groups
- Compare the length of stay between the two groups
- Compare the evolution of patients comfort state in the two treatment groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Major patient ≥ 18 years old
- •Medical diagnosis of Acute Respiratory Failure less than 48 hours
- •With partial pressure of carbon dioxide (PaCO2) > 45 and pH > 7.35 for less than 48 hours, with no indication of Non-Invasive Ventilation (NIV) placement
- •Underlying terrain of known or unknown chronic respiratory pathology (may be unknown at time of diagnosis) Examples : COPD, Bronchiectasis, Pulmonary fibrosis, asthma, sequelae pathologies …
- •All etiologies (infectious, cardiac decompensation, trauma, etc.)
- •Having given informed consent
- •Patient under a social security scheme
- •Possibility to include a patient having already been included in the study but suffering from a new episode of hypercapnic non acidic Acute Respiratory Failure with a free interval of 3 months
排除标准
- •Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies
- •Drug-induced Acute respiratory failure
- •Pneumothorax (X-ray pulmonary detachment)
- •Oxygen poisoning. In this case, PaCO2 will be asset again later with the purpose to include after oxygenotherapy decrease for a target SpO2 of 92% maximum
- •Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVII) Pneumonia
- •Tracheostomy
- •Prior treatment with chronic or initiated NIV just prior to treatment (e.g. Intensive Care Unit)
- •Respiratory Severity Criteria for Resuscitation Management
- •Agitation or non-cooperation
- •Pregnancy or breastfeeding
- •Person participating in other biomedical research
- •Any other reason that the investigator believes may interfere with the evaluation of the study objectives
- •Person under judicial protection (guardianship, curatorship)
- •Person deprived of liberty by a judicial or administrative decision
结局指标
主要结局
Failure of the Nasal High Flow
时间窗: Up to 2 weeks
Failure of the Nasal High Flow is defined by the occurrence of respiratory acidosis (pH\<7.35) within 2 weeks after admission
次要结局
- Responding patients phenotype(At Day 30 after hospital discharge)
- Respiratory rate(Up to 2 weeks)
- Dyspnea(Up to 2 weeks)
- pCO2 normalization time(Up to 2 weeks)
- Partial Pressure of Carbon dioxide (PCO2)(Up to 2 weeks)
- Bicarbonates(Up to 2 weeks)
- ROX index(Up to 2 weeks)
- Length of hospital stay(Up to 2 weeks)
- pH(Up to 2 weeks)
- Etiology of acute respiratory failure(Up to 2 weeks)
- Comfort Visual Analogic Scale (VAS)(Up to 2 weeks)
研究者
研究点 (6)
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