Maneuver for Evaluating the Potential Recruitability of the Pulmonary Parenchyme in Patients With ARDS
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Vrecruitable threshold (Vrec)
研究概览
简要总结
This study will try to define the threshold of the recruitable volume (Vrec), obtained by a derecruitment maneuver, that permit to identify patients responder or not to alveolar recruitment maneuvers.
详细描述
Background:
Acute respiratory distress syndrome (ARDS) is characterized by a major loss of lung volume due to alveolar flooding, atelectasis and consolidation. Alveolar recruitment maneuvers (ARM) permit to recruit non-aerated or poorly aerated lung tissue, and thus may improve gas exchange and oxygenation in patients with ARDS. However, ARM may also be harmful by overdistending the previously open lung tissue and can induce hemodynamic instability. The potential effectiveness and benefit of ARM depends on the patient's recruitability. A simple, routinely applicable bedside method to assess recruitability has been described in 2020 and is as efficient as multiple pressure-volume curves. We called it MERP for Potential for lung Recruitability Evaluation Method.
The investigators therefore propose to use this new method that determine lung recruitability as a diagnostic test to determine responder an non responder to ARM, and define a threshold.
Objectives:
The major aim is to determine the threshold of Vrec with the best sensitivity and specificity to define patient responders to alveolar recruitment maneuvers in ARDS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Moderate to severe ARDS as per the Berlin definition (Partial pressure of oxygen (PaO2)/Fraction of inspired oxygen (FiO2) < 200 mmHg) and within 72h of onset, with a FiO2 > 60%
- •Receiving assist/control mechanical ventilation with continuous sedation and neuromuscular blocker
- •In supine position during the procedures and measurements
- •Patients > 18 years of age
排除标准
- •Patients < 18 years of age
- •Pregnant woman
- •Patient deprived of freedom or under a legal protective measure
- •Hemodynamic instability defined as a mean arterial pressure < 65 mmHg or increasing doses of vasopressor drugs
- •Pneumothorax, pneumomediastinum, pleural fistula, sub-cutaneous emphysema
- •Chronic or recent severe cardiac dysfunction
- •Patient with a PEEP > 15 cmH20 before inclusion
- •Patient with no therapeutic perspective; candidate for palliative care exclusively or with end of life decision before inclusion
结局指标
主要结局
Vrecruitable threshold (Vrec)
时间窗: baseline
The threshold of Vrec that permits to identify responders to alveolar recruitment maneuvers defined by an improvement of the PaO2/FiO2 ratio \> 20% 15 minutes after ARM, through ROC curve and Youden index.
次要结局
- Evaluate the differences between responders and non responders to ARM concerning the following endpoints :(28 days)
- Calculate the mean time of realization of the MERP+ARM maneuvers(15-20 minutes)
- Number of patients presenting adverse events of ARM :(15-20 minutes)