A Prospective, Randomized, Controlled Trial to Evaluate the Efficacy of CPAP Delivered by Helmet in Comparison With Oxygen Therapy by Venturi Mask in Severe Acute Respiratory Failure Caused by Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation.
研究概览
简要总结
The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of achievement of criteria for endotracheal intubation during severe acute respiratory failure caused by pneumonia
详细描述
Pneumonia is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up to 30%.
Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration by Venturi mask for the treatment of severe acute respiratory failure in patients with pneumonia. .
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
- •men and women of any ethnic group;
- •age ≥18 years;
- •dyspnoea at rest with respiratory rate (RR) ≥30 breath/min or sign of respiratory distress
- •PaO2/FiO2 ratio≤250 evaluated during oxygen therapy supplied at least 1 hour through a Venturi mask with FiO2 ≥0,50
- •diagnosis of pneumonia as unique cause of severe acute respiratory failure
- •informed consent from each patient or from the closest relative in case of the patient's incapacity to give it
排除标准
- •diagnosis of other causes of severe acute respiratory failure
- •unstable angina or acute myocardial infarction;
- •acute respiratory acidosis with pH <7,35 and PaCO2 >45 mmHg;
- •systolic BP <90 mmHg despite fluid resuscitation or vasopressors;
- •severe arrhythmias;
- •convulsions;
- •degree of consciousness, Kelly score>3;
- •swallowing disturbance with increasing risk of aspiration pneumonia;
- •inability to protect the airway;
- •recent facial trauma or burn;
- •non-collaborative patient;
- •presence of open wounds (head, thorax, abdomen);
- •respiratory arrest or need of intubation;
- •pregnancy or suspect of pregnancy
结局指标
主要结局
to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation.
时间窗: the reaching of the following endotracheal intubation criteria maintained for at least one hour:
Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2\<90%;Exhaustion. The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician.
次要结局
- to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
研究者
Francesco Blasi
Professor of Respiratory Medicine
University of Milan