NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ICU length of stay of telemetry length of stay
研究概览
简要总结
The goal of this study is to compare two different modes of noninvasive ventilation in hypercapnic respiratory failure. The investigators will compare AVAPS and BIPAP S/T and hypothesize that AVAPS will result in a decreased length of stay in the ICU or on telemetry. Currently, noninvasive ventilation is the standard of care for hypercapnic respiratory failure. However, the most effective mode for patients with hypercapnic respiratory failure is unclear.
详细描述
- Overall Study Design and Plan
This is a single center, randomized trial that will include a total of 100 adult subjects aged 18 or older with hypercapnic respiratory failure of all etiologies (i.e. "all comers"). The investigators will randomize patients in a single-blinded (patient blinded) fashion to BIPAP S/T or AVAPS during the duration of their hospitalization. The investigators will assess ABG at baseline, 1 hour after initial placement on BIPAP S/T or AVAPS, and between hours 24-48 of use. The investigators will record the pre-NIV pH and PaCO2, post-NIV pH and PaCO2, length of hospital stay in the medical ICU or telemetry unit, days on NIV, need for intubation (if occurred), transition to medical ICU care in patients who were initially admitted to telemetry, and in-hospital mortality. All collected laboratory data are already done as part of usual care for all patients placed on NIV when a patient is on the telemetry unit or medical ICU. The groups will undergo stratified randomization based on whether they are initially admitted to medical ICU or medical telemetry. Patients from medical ICU or telemetry units will be randomized to one of the following arms:
Arm 1: AVAPS mode Arm 2 2: BIPAP S/T mode
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
- •Provision of signed and dated informed consent form directly by the patient; consent can also be obtained via a legal patient representative/health care proxy/surrogate
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 or older
- •Diagnosed with hypercapnic respiratory failure on admission (ABG)
- •Admitted to Lenox Hill Hospital medical intensive care unit or telemetry unit
- •Requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure
排除标准
- •Patients who require ventilation at predetermined tidal volumes
- •Patients who require rapid and frequent IPAP adjustments to maintain a consistent tidal volume
- •Age less than 18 years of age
- •Currently intubated
- •Chronic tracheostomy
- •Hypotension
- •Epistaxis (nosebleed)
- •Untreated pertussis
- •Acute sinusitis or Otitis media
- •Patients at risk of aspirating gastric contents
- •Patients with lack of spontaneous respiratory drive
- •Patients with the inability to maintain a patent airway or adequately clear secretions
- •Prisoners or other institutionalized individuals
结局指标
主要结局
ICU length of stay of telemetry length of stay
时间窗: within one week of hospital discharge (5-7 days)
In patients admitted to the medical ICU, the primary endpoint is ICU length of stay. This will be the number of days a patient is admitted from day 1 of admission until the day of discharge. In patients admitted to medical telemetry unit, the outcome is telemetry length of stay. This will be the number of days a patient is admitted from day 1 of admission until the day of discharge.
次要结局
- Days on NIV(within one week of hospital discharge (5-7 days))
- Normalization of pH(at the time of hospital discharge (an average of 5-7 days))
- Subgroup analysis (logistic regression or p-value) comparing outcome 5- days on NIV reported as difference between groups (with p-value and/or standard deviation)(through study completion, an average of 1 year)
- Difference in PaCO2 value with NIV(within 24-48 hours after noninvasive ventilation)
- Subgroup analysis (logistic regression or p-value) comparing outcome 4- time to normalization of pH reported as difference between groups (with p-value and/or standard deviation)(through study completion, an average of 1 year)
- Subgroup analysis (logistic regression or p-value) comparing outcome 6- need for intubation reported as difference between groups (with p-value and/or standard deviation)(through study completion, an average of 1 year)
- Time to normalization of pH(at the time of hospital discharge (an average of 5-7 days))
- Need for intubation(within one week of hospital discharge (5-7 days))
- Subgroup analysis (logistic regression or p-value) comparing outcomes 1- ICU or telemetry length of stay based on the underlying cause of hypercapnic respiratory failure(through study completion, an average of 1 year)
- Subgroup analysis (logistic regression or p-value) comparing outcome 7- need for ICU stay reported as difference between groups (with p-value and/or standard deviation)(through study completion, an average of 1 year)
- Need for ICU stay(within one week of hospital discharge (5-7 days))
- Subgroup analysis (logistic regression or p-value) comparing outcome 2- difference in paCO2 reported as difference between groups (with p-value and/or standard deviation)(through study completion, an average of 1 year)