Dokuz Eylul University School of Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PaCO2 values
研究概览
简要总结
The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in hospital.
详细描述
Non-invasive positive pressure ventilation (NIMV) is a life-saving procedure for patients with hypoxic and/or hypercapnic respiratory failure. AVAPS (average volume assured pressure support) is a noninvasive ventilation mode which has been developed to assure volume and pressure controlled respiratory support. AVAPS can ensure a constant tidal air volume to the patient with variable pressure support. Thus the positive features of the volume and pressure controlled support, which have a positive impact on the healing and recovery processes are combined.
This study aims to compare, in a randomized order, BPAP ST/T and BPAP ST / T Mode with AVAPS, in patients with hypercapnic respiratory failure in the emergency department.
Subjects: One hundred and two patients with hypercapnic respiratory failure will be included.
Primary outcome; decrease in the PaCO2 values
Secondary outcomes are stated as; Failure of treatment options, or change of the NIMV mode due to patient noncompliance or the patient's need for intubation and length of hospital stay (length of stay in the hospital from the emergency department).
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
- Single (Participant)
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
- •PaCO2 > 45mmHg and any of the following
- •SaO2 <90% on air
- •SaO2 <93% on >6 Litres O2/min
- •Inability to speak in sentences due to respiratory distress
- •Respiratory rate > 24/min
- •Altered mental status
- •The use of accessory muscles of respiration
排除标准
- •Respiratory arrest or unstable cardiorespiratory status
- •Suspected Pneumothorax
- •Urgent need for intubation
- •Systolic blood pressure < 90 mmHg
- •Inability to protect airway
- •Facial deformity
- •Facial, esophageal, or gastric surgery history
- •All trauma patients
- •Acute myocardial infarction
- •Severe arrythmias
- •Refractory nausea and vomiting
研究组 & 干预措施
BPAP ST/T
Non-invasive Ventilation with BPAP ST/T mode
干预措施: Noninvasive mechanical ventilation (Device)
AVAPS
Non-invasive Ventilation with AVAPS mode
干预措施: Noninvasive mechanical ventilation (Device)
结局指标
主要结局
PaCO2 values
时间窗: On arrival, at one hour, and at two hourly intervals thereafter
Will measure change in PaCO2 values in the blood gase analysis of patients comparing those treated with BPAP ST/T and those with AVAPS
次要结局
- Length of hospital stay(up to 6 months)
- Failure of treatment options(During the treatment)
- The time of treatment(During the treatment)
研究者
Başak Bayram
Assistant Professor Dr.
Dokuz Eylul University