Open Randomized Controlled Clinical Trial Comparing Oxygen Therapy by High Flow Nasal Cannulae and by Venturi Mask in the Treatment of Acute Respiratory Failure Due to Severe Pneumonia (Hi Flow Oxygen vs Venturi Mask In Pneumonia)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Clinical Failure
研究概览
简要总结
The primary objective of this study is to compare the efficacy of treatment with HFNC (group A) compared to administration of oxygen therapy by Venturi mask (group B, standard therapy) in terms of reaching of endotracheal intubation criteria during acute respiratory failure due to severe pneumonia.
Inclusion Criteria: Respiratory rate (RR) at rest ≥20 bpm or presence of respiratory distress (severe dyspnoea at rest or use of accessory respiratory muscles or abdominal paradox); PaO2 / FiO2 ≤250 during oxygenation with Venturi Oxygenation mask at FiO2 = 50% administered for at least 60 minutes; Diagnosis of pneumonia as the sole cause of acute respiratory failure. Randomization: 150 consecutive patients will be randomized either to High Flow Nasal Cannula Oxygenation (75 patients, HFNCO with flow ≥ 60 L/min and FiO2 to maintain SpO2 ≥ ) or Venturi Mask Oxygenation (control, 75 patients).
Patients from both groups will be treated with antibiotic therapy according to the IDSA/ATS 2007 guidelines for community-acquired pneumonia and the IDSA/ATS 2016 guidelines for hospital-acquired pneumonia.
Intubation Criteria:
MAJOR CRITERIA:
Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability Need for sedation
MINOR CRITERIA (maintained for ≥1h):
Reduction ≥30% of the value of the PaO2/FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale Persistence or onset of respiratory distress Vital parameters, Kelly scale and arterial blood gas analysis (BGA) will be performed on admission, and at 1, 24, at 48 hours, at the achievement of clinical stability, and whenever there is a clinical worsening.
Patients enrolled in HFNC arm will continue HFNC oxygenation until clinical stability, defined as:
Body temperature ≤ 37°C and ≥36°C for 24 consecutive hours Good ability in swallowing CRP and WBC normalization trend than the admission exams Hemodynamic stability Lack of respiratory distress SpO2 94-98% The primary outcome variable is the proportion of patients who reach the endotracheal intubation criteria - regardless of the actual intubation rate - within the first 48 hours of treatment. The primary analysis will be performed on the ITT population
详细描述
1.1 Basic information Pneumonia is still the most important infectious disease in terms of morbidity and mortality and is one of the most common causes of hospitalization for acute respiratory failure. The aim of this trial is to compare the use of High Flow Nasal Cannula (HFNC) oxygenation versus standard oxygen therapy in patients with hypoxemia due to pneumonia.
1.2 Rationale The oxygenation through HFNC allows the use of high concentrations of oxygen administered by a high gas flow, heated and humidified. This device allows both higher FiO2 and the presence of a positive end-expiratory pressure (PEEP) with a greater gas exchange.
2. Aims OF THE STUDY 2.1 Primary aim The primary aim of this study is to compare the efficacy of treatment with HFNC (group A) compared to administration of oxygen therapy by Venturi mask (group B, standard therapy) in terms of clinical failure during acute respiratory failure due to severe pneumonia 2.2 Secondary aims
The secondary aims are:
30-day mortality gas exchange improvement in-hospital length of stay adverse events as per prior
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 (Outcomes Assessor)
盲法说明
Assessor will be blind to the treatment allocation
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
- •male or female of any ethnic group
- •age greater than or equal to 18 years;
- •respiratory rate (RR) at rest ≥ 20 breaths/minute or presence of respiratory distress (severe - dyspnea at rest or use of accessory respiratory muscles or paradox abdominal movement) PaO 2/ FiO 2 ≤250 during oxygen therapy with Venturi mask with FiO 2 50% administered for at least 60 minutes;
- •diagnosis of pneumonia as the unique cause of acute respiratory failure
- •informed consent obtained from the patient or the closest relative in case of patient's inability to give it.
排除标准
- •other diagnoses (instead of pneumonia) as a cause of acute respiratory failure
- •unstable angina and acute myocardial infarction in place;
- •Acute respiratory acidosis with pH <7.35 and PaCO 2 > 45 mmHg;
- •systolic blood pressure <90 mmHg unresponsive to fluids or with amines
- •severe arrhythmias;
- •epileptic seizures;
- •the degree of vigilance depending on the Kelly scale > 3 (see Appendix II)
- •impaired swallowing, which increases the risk of pneumonia aspiration inability to protect airways
- •craniofacial trauma or burns
- •uncooperative patient
- •presence of open wound (skull, chest, abdomen)
- •respiratory arrest or need for intubation
- •ongoing pregnancy or suspected
研究组 & 干预措施
Venturi Mask Oxygenation
Venturi Mask Oxygenation, with an FiO2 such as to maintain an SpO2 ≥ 92% for at least 48 hours until clinical stability
干预措施: Venturi Mask Oxygenation (Device)
High Flow Nasal Cannula Oxygenation
High Flow Nasal Cannula Oxygenation with a minimum flow ≥ 60L / min, and an FiO2 such as to maintain a SpO2 ≥ 92% for at least 48 hours until clinical stability
干预措施: High Flow Nasal Cannula Oxygenation (Device)
结局指标
主要结局
Clinical Failure
时间窗: Participants will be followed for the duration of hospital stay, for a maximum of 30 days
The primary endpoint is the achievement of clinical failure defined as: At least one of major criteria Or At least 2 or more of the minor criteria maintained for at least 1 consecutive hour: MAJOR CRITERIA: Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability (Heart Rate ≤ 50 bpm with loss of alertness or Systolic Blood Pressure ≤ 70 mmHg) Need for sedation MINOR CRITERIA (observed for ≥ 1 hour): Reduction ≥30% of the value of the PaO 2 / FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale (see Appendix II) Persistence or onset of respiratory distress ( severe dyspnea or use of accessories respiratory muscles or paradoxical abdominal motion)
次要结局
- adverse events(Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week)
- hospital stay(Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week)
- 30-day mortality after admission(day 30)
- improvement of respiratory exchanges compared to baseline(hospital admission (=day 1), day 2, until the achievement of clinical stability)
研究者
Roberto Cosentini
MD, Head of Emergency Room
Papa Giovanni XXIII Hospital