A Pilot Randomized Controlled Study of Non-invasive Oxygenation and Ventilation in Patients With Acute Hypoxemic Respiratory Failure (AHRF): A Comparison of Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula (HFNC)
试验速览
- 阶段
- 不适用
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Rate of intubation
研究概览
简要总结
Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study.
详细描述
Patients with acute hypoxemia leading to respiratory failure are frequently supported by endotracheal intubation and mechanical ventilation. Unfortunately an invasive approach to support is associated with risks of lung injury, infection, need for heavy sedation, and increased mortality. Non-invasive oxygen delivery, by mask (BiPAP or CPAP), high flow nasal cannula or helmet interface, is better tolerated and reduces risks associated with invasive mechanical ventilation. A growing body of medical literature and clinical experience suggests that non-invasive oxygen delivery can prevent the need for endotracheal intubation in some patients. This proposal will compare two different modes of non-invasive oxygen delivery: helmet and high flow nasal cannula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age ≥ 18 years
- •AHRF defined as:
- •A ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) between 100 - 250 mm Hg while breathing O2 from Venturi mask, or other delivery system that allows quantification of FiO2 such as Mask-NIPPV or HFNC.
- •When no arterial blood gas (ABG) result available, use transcutaneous oxygen saturation measurement (SpO2) to impute PaO2 (Appendix A.2 for Table of PaO2 / FiO2 imputed from SpO2 [Brown 2017]. If no oxygenation data prior to use of Mask-NIPPV or HFNC are available, then P/F ratio 100 - 250 on Mask-NIPPV or HFNC meets this criterion.
- •Respiratory rate (RR) ≥24 /min and/or subjective shortness of breath (Modified Borg Dyspnea Scale ≥ 2)
排除标准
- •P/F Ratio < 100 (Severe ARDS) on quantifiable FiO2
- •More than 24 hours has elapsed since the patient met criteria for AHRF (Inclusion #2 and 3, above)
- •Urgent need for intubation
- •Criteria for intubation:
- •i. RR>40 ii. Lack of improvement of respiratory muscle fatigue iii. Copious tracheal secretions that require frequent suctioning iv. Acidosis with a potential Hydrogen (pH) <7.35 v. Acute hypercarbia (PaCO2 > 45 mm Hg) vi. SpO2 < 88% for more than 5 minutes despite FiO2 and non-invasive support vii. Respiratory or cardiac arrest viii. Glasgow Coma Scale ≤ 8
- •Contraindication to HFNC, Helmet-NIPPV, or Mask-NIPPV
- •Upper airway obstruction, facial trauma
- •Copious secretions, airway bleeding, epistaxis or vomiting
- •Primary cause of respiratory failure is exacerbation of chronic obstructive pulmonary disease (COPD) or asthma
- •Elevated intracranial pressure >20 mm Hg
- •Home mechanical ventilation except for CPAP/BiPAP used solely for sleep disordered breathing
- •Persistent hemodynamic instability (systolic blood pressure (SBP)<90 or mean arterial pressure (MAP)<60 despite IV fluid resuscitation, or norepinephrine dose > 0.1 mcg/kg/min or equivalent vasopressor dose)
- •Plan for procedure during which NIPPV or HFNC is contraindicated. Okay to enroll if procedure is complete and AHRF persists within 24 hours.
- •Absence of airway protective gag reflex or cough
- •Tracheostomy
- •Lack of informed consent
- •Actual body weight exceeding 1 kg per cm of height
- •Diffuse alveolar hemorrhage
- •Severe acute pancreatitis as etiology for hypoxemia
- •Recent upper gastrointestinal surgical anastomosis within the past 30 days
- •Enrollment in another clinical trial within the past 30 days
- •Unsuitable for non-invasive ventilation in the judgment of the treating MD
- •Decision to withhold life-sustaining treatment. Patients with Do-Not-Resuscitate (DNR) or No Cardiopulmonary resuscitation (No CPR) order may be enrolled.
- •Do not intubate order
研究组 & 干预措施
Helmet oxygenation group
Patients randomized to helmet NIPPV will receive noninvasive oxygenation and ventilation via a latex free helmet
干预措施: Helmet (Device)
High Flow Nasal Oxygen
Oxygen will be passed through a heated humidifier and applied continuously through large-bore nasal prongs
干预措施: High Flow Nasal Oxygen (Device)
结局指标
主要结局
Rate of intubation
时间窗: 28 days
To determine the rates of intubation for subjects with Acute Hypoxemic Respiratory Failure (AHRF) managed by non-invasive modalities High Flow Nasal Cannula (HFNC) and Helmet NIPPV.
次要结局
- Total daily dose of sedative medications (milligram)(7 days)
- ICU free-days to day 28(28 days)
- Intubation-free days through day 28(28 days)
- Rate of cross-over between groups(28 days)
- Tolerance of the devices(28 days)
- Richmond Agitation and Sedation Scale (RASS)(7 days)
- Highest level of daily mobility through day 7(7 days)
- Rate and reason for exclusion from enrollment to this trial of Helmet-NIPPV vs. HFNC(through study completion, an average of 1 year)
- Rate of intubation in non-enrolled patients that meet inclusion and exclusion criteria(28 days)
- Time to intubation(28 days)
- Organ-failure-free days through day 28(28 days)
- Mortality prior to discharge from hospital (up to study day 90 whichever comes first)(90 days)
- Hospital mortality to day 28(28 days)
- Hospital length of stay(28 days)
- Complications(28 days)
- Ventilator associated pneumonia, barotrauma(28 days)
- Confusion Assessment Method for the ICU (CAM-ICU)(7 days)
研究者
Mark Tidswell
Associate Professor of Medicine and Surgery
Baystate Medical Center