Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Number of Ventilator-Free Days (VFD) by Day 28
研究概览
简要总结
This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator.
Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.
详细描述
Study Design:
Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/fraction of inspired oxygen (FiO2) table. All patients will have esophageal balloons placed with baseline measurement of Ptp. Patients randomized to the intervention arm will then undergo titration of PEEP based on Ptp measurements to achieve "Optimal PEEP," defined as end expiratory Ptp of 0 to +2 cm water (H2O).
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
Due to the obvious treatment differences between the two groups, blinding of treatment group will be impossible. However, the investigators will have one outcome assessor who will have access only to the data necessary to determine the primary outcome (Ventilator-Free Days at 28-days), and this assessor will be blinded to treatment group using built-in REDCap tools.
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
- •Body mass index greater than or equal to 40
- •Acute respiratory failure requiring mechanical ventilation
排除标准
- •Refusal to give consent by the subject or their legally authorized representative
- •Abdominal compartment syndrome
- •Chest tube for pneumothorax
- •Having been on a ventilator for >4 days
- •Suspicion of or known intracranial hypertension
- •Anticipated extubation within 24 hours
- •Chronic ventilator dependence
- •Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy)
- •Incarceration
结局指标
主要结局
Number of Ventilator-Free Days (VFD) by Day 28
时间窗: 28 days
The number of days a patient is alive and free from the ventilator up to day 28.
次要结局
- ICU Length of Stay(maximum duration of ICU stay, up to 46 days)
- Number of Patients Receiving a Tracheostomy(during mechanical ventilation, up to 28 days)
- Number of Participants Reintubated(72 hours after extubation)
- Lowest Richmond Agitation and Sedation Scale(during mechanical ventilation, up to 28 days)
- Hospital Length of Stay(maximum duration of hospital stay, up to 83 days)
- Number of Patients Extubated Early(28 days)
- Highest Richmond Agitation and Sedation Scale(during mechanical ventilation, up to 28 days)