Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure Receiving Non-invasive Respiratory Supports: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- respiratory pattern
研究概览
简要总结
Protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI) as a possible mechanism aggravating lung damage in these patients.
The aim of this study is evaluate the tidal volume, measured by respiratory inductance plethysmography, in patients receiving different non invasive respiratory support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Respiratory Failure (ARF) ( 100 <PaO2/FiO2 <300) due to Covid-19 infection
- •Informed consent
- •Enrollment within the first 24 hours after ARF
排除标准
- •Clinical, radiological or istological evidence of chronic pulmonary disease.
- •Body Mass Index (BMI) > 30 kg/m2;
- •Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)
- •Chest wall disease
- •Heart failure
- •Severe hemodynamic instability ( need for amine support)
- •Acute coronary syndrome (ACS)
- •Severe arrhythmia
- •Patients unable to protect respiratory airways
- •Respiratory arrest and need for endotracheal intubation
- •Pregnancy
- •Need for sedation
- •Home long-term oxygen therapy
研究组 & 干预措施
spontaneous breathing trial
the patients will be asked to breathe spontaneously using their actual low oxygen flow
干预措施: Ventimask (Device)
spontaneous breathing trial
the patients will be asked to breathe spontaneously using their actual low oxygen flow
干预措施: High Flow Nasal cannula (HFNC) (Device)
spontaneous breathing trial
the patients will be asked to breathe spontaneously using their actual low oxygen flow
干预措施: Helmet CPAP (Device)
spontaneous breathing trial
the patients will be asked to breathe spontaneously using their actual low oxygen flow
干预措施: Non Invasive Ventilation (NIV) (Device)
Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
干预措施: Non Invasive Ventilation (NIV) (Device)
High Flow Nasal cannula (HFNC)
The patients will be asked to breathe with HFNC of 40 L/min
干预措施: Ventimask (Device)
High Flow Nasal cannula (HFNC)
The patients will be asked to breathe with HFNC of 40 L/min
干预措施: High Flow Nasal cannula (HFNC) (Device)
High Flow Nasal cannula (HFNC)
The patients will be asked to breathe with HFNC of 40 L/min
干预措施: Helmet CPAP (Device)
High Flow Nasal cannula (HFNC)
The patients will be asked to breathe with HFNC of 40 L/min
干预措施: Non Invasive Ventilation (NIV) (Device)
Helmet CPAP
the patients will be asked to breathe with the Helmet CPAP
干预措施: Ventimask (Device)
Helmet CPAP
the patients will be asked to breathe with the Helmet CPAP
干预措施: High Flow Nasal cannula (HFNC) (Device)
Helmet CPAP
the patients will be asked to breathe with the Helmet CPAP
干预措施: Helmet CPAP (Device)
Helmet CPAP
the patients will be asked to breathe with the Helmet CPAP
干预措施: Non Invasive Ventilation (NIV) (Device)
Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
干预措施: Ventimask (Device)
Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
干预措施: High Flow Nasal cannula (HFNC) (Device)
Non Invasive Ventilation (NIV)
the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
干预措施: Helmet CPAP (Device)
结局指标
主要结局
respiratory pattern
时间窗: 30 minutes
the way the patient is breathing recorded by respiratory inductance plethysmography (RIP)
respiratory mechanics
时间窗: 30 minutes
the inspiratory effort of the patient recorded by esophageal pressure
次要结局
- Blood pressure (BP) and Heart rate (HR) measurements(30 minutes)
- changes in Arterial Blood Gases (ABGs)(immediately after intervention)
- Comfort score(immediately after intervention)
- Dyspnea score(immediately after intervention)
研究者
dr. Stefano Nava
Stefano Nava, Professor of Respiratory Medicine/ Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ S.Orsola-Malpighi University Hospital, Bologna (IT)
IRCCS Azienda Ospedaliero-Universitaria di Bologna