Noninvasive Ventilation For Postoperative Acute Respiratory Failure: Comparison of Conventional Helmet With a Novel Full-Face Mask.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Differences in PaO2/FiO2 ratio with respect to baseline (before NIV) values.
研究概览
简要总结
The aim of this study is to compare two methods of delivery of noninvasive mechanical ventilation (NIV).
Since patient compliance and mechanical characteristics of the delivery devices are two fundamental variables in the success of NIV during acute respiratory failure, our hypothesis is that an improved patient-ventilator interface may improve the efficacy of therapy.
详细描述
Noninvasive ventilation (NIV) is the delivery of ventilatory support without the need for an invasive artificial airway. The use of noninvasive positive-pressure ventilation (NPPV) in acute respiratory failure has been steadily increasing for intensive care unit (ICU) patients. Noninvasive ventilation can often eliminate the need for intubation or tracheostomy and preserve normal swallowing, speech, and cough mechanisms. Discomfort of the device is one of the reason for the failure of NIV (30-40% of the cases).
The Novastar oro-nasal mask (Dräger Medical, Lubeck, Germany) is a flexible, transparent mask shell with a fine silicone gel cushion which adapts to the wearer's face. The pliable ring embedded inside the flexible clear shell allows the mask to be bent and adjusted to fit the patient's face (customized fit), while minimizing leakages. The mask has magnetic, self aligning clips for capture and secure fastening of the mask headgear. The magnetic clips are self-aligning.
The transparent flexible helmet for NIV (Rüsch 4-Vent, Teleflex Medical Europe, Athlone, Ireland) is fixed with two straps passing through each armpit. The braces are protected by hydrocolloid strips to prevent axillary decubitus. It is important to chose the right size of the helmet to avoid air leakages in the neck region. Two filters in the in- and expiratory way are necessary to reduce noise.
Different devices may lead to varying degrees of discomfort and, thus, improve compliance. Better tolerability of NIV may improve its efficacy. Therefore, we planned this randomized controlled trial to investigate whether different modalities of NIV delivery may affect therapeutical efficacy.
No randomized trials have compared helmets to the NOVASTAR full-face masks. This randomized, controlled study aims to assess whether the new full face mask improves gas exchange in patients admitted to ICU because of acute postoperative respiratory failure.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ongoing or recent history of respiratory failure (either primary or secondary)
- •PaO2 <60 mmHg if breathing room air or PaO2/FiO2 <300 mmHg if receiving supplemental oxygen
- •Acute dyspnea with respiratory rate >25 bpm and accessory muscle recruitment and/or paradoxical abdominal breathing
排除标准
- •Refusing noninvasive ventilation
- •Comatose (Glasgow Coma Scale <8) or unable to maintain a patent airway
- •Hemodynamically unstable (systolic blood pressure <80 mmHg on recruitment, or receiving vasopressors/inotropes; ongoing angina/myocardial infarction; newly-developed arrhythmia with hemodynamic impact)
- •Having recently (≤2 weeks) undergone oesophageal or upper respiratory tract surgery
结局指标
主要结局
Differences in PaO2/FiO2 ratio with respect to baseline (before NIV) values.
时间窗: 24 h
次要结局
- PaO2/FiO2 improvement at 1 h after beginning of ventilation.(1 h after enrollment)
- Arterial carbon dioxide partial pressure (PaCO2)(At 1 and 24 h post-enrollment)
- Arterial blood pressure and incidence of hypotension (systolic blood pressure <90 mmHg or mean arterial blood pressure <60 mmHg)(Up to 24 h post-enrollment)
- Intensive care unit stay(Up to 30 days)
- In-hospital mortality(Up to 30 days)
- Device-related complications: pressure sores, skin necrosis, air leak, eye inflammation, gastric distension.(Up to 24 h post-enrollment)
- Patient's rating of comfort with the device. Numerical rating scale ranging from 1 (unbearable) to 5 (very good.)(At 1 and 24 h post-enrollment)
- Success rate of NIV as delivered with either helmet or full-face mask. Success is defined as ≥50 mmHg improvement of PaO2/FiO2 ratio.(24 h from initiation of therapy)
- Need for intubation(Up to 24 h post-enrollment)
研究者
Guido Fanelli
Professor of Anesthesiology and Director, Anesthesia, Critical Care and Pain Medicine
University of Parma