Ultrasound Diaphragmatic Evaluation in Acute Hypoxic - Hypercapnic Respiratory Failure (ARF) Patients Undergoing Non Invasive Ventilation: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Feasibility of diaphragm ultrasound function evaluation (excursion and thickening) in acute hypoxic - hypercapnic respiratory failure (ARF) during the first two hours after emergency department admission.
研究概览
简要总结
Mortality of acute hypoxic - hypercapnic respiratory failure (ARF) patients underwent invasive mechanical ventilation is demonstrated to be higher than in patients who underwent only non invasive mechanical ventilation (NIV).
There is an increased need to detect more predictive factors for NIV failure, in order to better identify patients most at risk of facing negative outcomes.
The aim of this experimental pilot study is to evaluate the feasibility of the ultrasound of diaphragm in ARF patients underwent non invasive mechanical ventilation ( primary endpoint ).
Furthermore the secondary aim is to observe any relationship between diaphragmatic function (excursion), diaphragmatic thickening and the timing of arterial blood gases (ABGs) compensation in patients with ARF undergoing NIV treatment; additional outcomes are: correlation with dyspnea level, time of mechanical ventilation, NIV failure, rate of tracheostomy, length of stay in ICU and in-hospital and 90-day mortality.
详细描述
Inclusion criteria: respiratory failure resulting in respiratory acidosis to be treated with NIV, age> = 18 years
Exclusion criteria: acute pulmonary edema, coexisting interstitial pathologies, neuromuscular pathologies, thoracic cage's deformity, previous diaphragmatic paralysis, hemodynamic instability, intracranial hypertension, pregnancy, absolute contraindications to NIV, need for immediate intubation, recent thoracotomy, presence of pneumothorax or pneumomediastinum.
After patient's triage, transfer to Shock Room and primary assessment by emergency department staff ,diaphragmatic ultrasound is performed when NIV indication is given.
NIV is delivered with a facial mask; ventilation is set in NIV application, pressure support mode. Positive end expiratory pressure (PEEP) and Inspired oxygen fraction (FiO2) are adjusted to obtain a peripheral oxygen saturation (Spo2) between 88-92%. The pressure support is set to achieve a target volume of between 6-8 (ml / kg) and a respiratory rate < 30 respiratory acts per minute.
Respectively one and two hours after starting NIV, diaphragmatic ultrasonography and ABGs analysis are again performed.
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
- •respiratory failure resulting in respiratory acidosis to be treated with NIV
- •Age> = 18 years
排除标准
- •acute pulmonary edema
- •coexisting interstitial pathologies
- •neuromuscular pathologies
- •thoracic cage's deformity
- •previous diaphragmatic paralysis
- •hemodynamic instability
- •intracranial hypertension
- •pregnancy
- •absolute contraindications to NIV
- •need for immediate intubation,
- •recent thoracotomy
- •presence of pneumothorax or pneumomediastinum
研究组 & 干预措施
D-US ARF
Diaphragmatic evaluation, i.e thickening fraction (%) and excursion (millimeters), will be performed 3 times in the first two hours after acute hypoxic - hypercapnic respiratory failure (ARF) patients admission
干预措施: D-US ARF (Diagnostic Test)
结局指标
主要结局
Feasibility of diaphragm ultrasound function evaluation (excursion and thickening) in acute hypoxic - hypercapnic respiratory failure (ARF) during the first two hours after emergency department admission.
时间窗: 2 hours
Ultrasound will be performed before starting NIV, after 1 and 2 two hours of NIV application
次要结局
- Arterial blood carbon dioxide (PaCO2) compensation evaluation(2 hours)
- Monitoring diaphragmatic function in terms of thickening at 2 hours(2 hours)
- Monitoring diaphragmatic function in terms of excursion at 1 hour(1 hour)
- dyspnea level at 1 hour(1 hour)
- Days spent in intensive care unit(28 days)
- dyspnea level at 0 hour(0 hour)
- Monitoring diaphragmatic function in terms of thickening at 1 hour(1 hour)
- Monitoring diaphragmatic function in terms of excursion at 0 hour(0 hour)
- Monitoring diaphragmatic function in terms of excursion at 2 hours(2 hours)
- dyspnea level at 2 hours(2 hours)
- Monitoring diaphragmatic function in terms of thickening at 0 hour(0 hour)
- Days spent in in hospital(90 days)
研究者
Gianmaria Cammarota
Principal Investigator, MD of ICU staff
Azienda Ospedaliero Universitaria Maggiore della Carita