NCT07791225尚未招募不适用
A Bayesian, Operationally Seamless Adaptive Phase 2A/2B, Open-label, Multi-center, Randomized, Two-part Trial to Evaluate the Safety, Efficacy, and Optimal Tidal Volume Distribution of Variable Ventilation (VV) in Participants Undergoing Mechanical Ventilatory Support for Acute Respiratory Distress Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Safety assessed by the incidence of pre-specified AEs over the first 24 hours
研究概览
简要总结
The goal of this clinical trial is to learn if a breathing machine (ventilator) method called "variable ventilation" can help protect the lungs of adult patients with acute respiratory distress syndrome (ARDS) who need help breathing through a ventilator. In variable ventilation, the size of each breath given by the machine changes slightly from breath to breath, instead of staying the same size in every breath. The study has two parts, A (safety and feasibility) and B (efficacy). This entry will cover the part A (safety study).
The main questions part A aims to answer are:
- Is variable ventilation safe to use in adults with ARDS?
- Is it feasible to deliver this method of ventilation to patients?
Researchers will compare variable ventilation to the standard breathing machine method used today to see if variable ventilation is safe and feasible.
Participants will be placed on an FDA approved ventilator that can deliver conventional mechanical ventilation and variable ventilation. Participants will:
- Have a period of stabilization on conventional ventilation, followed by 24 hours of variable ventilation, followed by 24 hours of conventional ventilation.
- Be checked regularly for breathing, oxygen levels, lung function, and plasma biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking will be used in this study.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥21 years old admitted to the Surgical, Trauma, Burn, Coronary or Medical ICUs with ARDS according to the Berlin criteria [50] and requiring mechanical ventilation will be eligible for inclusion.
- •Not more than 96 hours of mechanical ventilation before randomization
- •Anticipated need for at least 48 more hours of controlled mechanical ventilation
- •Intubated and mechanically ventilated for ARDS according to the Berlin criteria
- •Hypoxemia of acute onset, within the past 7 days
- •Mild or moderate hypoxemia, PaO2/FiO2 ratio 100 - 300 mm Hg
- •Presence of a risk factor for ARDS
- •Respiratory failure not fully explained by cardiac failure or fluid overload
- •Bilateral opacities not explained by effusions, lobar collapse, or nodules
排除标准
- •Demographic
- •Age less than 21 years
- •Pregnant or breastfeeding
- •Concurrent participation in another investigational drug study
- •Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if they would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- •No consent or inability to obtain consent or appropriate legal representative not available
- •Physician refusal to allow enrollment in the trial
- •Moribund patient not expected to survive 24 hours
- •Treating team unwilling to use ARDS network low tidal volume strategy or variable ventilation mode
- •Use, or planned use of ECMO
- •Stroke (ischemic or hemorrhagic) or traumatic brain injury (TBI) within the prior 3 months
- •Burns > 40% total body surface area (TBSA)
- •Severe airway inhalational injury
- •Diffuse alveolar hemorrhage
- •Any of the following hallmarks of Severe COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4
- •FEV1 < 50% predicted
- •Resting arterial blood gas values PaO2<55, SaO2<88%, or PaCO2>55
- •Home invasive or non-invasive ventilation other than for sleep apnea
- •Cor Pulmonale
- •Candidate for, or has received, lung volume reduction surgery, bronchoscopic intervention to reduce end-expiratory lung volume, or lung transplantation
- •Any of the following cardiac problems:
- •Acute myocardial infarction (MI) or acute coronary syndrome within the last 90 days
- •Coronary artery bypass graft (CABG) surgery within 30 days
- •Angina pectoris, or use of nitrates, with activities of daily living
- •Cardiopulmonary disease classified as NYHA class IV
- •Physiological Exclusions
- •Evidence of current barotrauma (e.g., pneumothorax, pneumomediastinum, or subcutaneous emphysema)
- •Hemodynamic instability defined by inability to maintain a mean arterial pressure > 60 mm Hg.
- •Other respiratory instability PEEP ≥18 cmH2O, suctioning more than hourly, Pplateau > 35 cm H2O, severe respiratory acidosis pH<7.
- •Increased ICP > 20 cmH2O or mechanism of injury leading to concern for increased ICP
- •Active bleeding with hemodynamic instability.
结局指标
主要结局
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
时间窗: Maximum of 24 hours of VV
Barotrauma
次要结局
- Lung mechanics(Every 12 hours to maximum of 24 hours of VV)
- Gas exchange(Every 12 hours to maximum of 24 hours of VV)
- Feasibility of VV implementation.(Every 12 hours during 24 hours of VV)
研究者
Rebecca Baron
Associate Professor of Medicine
Brigham and Women's Hospital
研究点 (5)
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