Transpulmonary Pressure During Volume Controlled Mechanical Ventilation Versus Airway Pressure Release Ventilation for Hypoxic Respiratory Failure - a Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Median peak transpulmonary pressure
研究概览
简要总结
The study examines individuals admitted to the intensive care unit due to breathing difficulties resulting in not getting enough oxygen into their bodies. These patient will receive mechanical ventilation and this study aims to determine how the pressure inside the lungs changes when using two different modes of mechanical ventilation. The goal is to improve management and care of breathing difficulties by gaining insight into changes in lung pressure during mechanical ventilation, as well as comparing the effectiveness of the two ventilator modes.
详细描述
As hypoxic respiratory failure is an acute condition, this trial will enrol temporarily incompetent patients and obtain consent from the patient's next of kin and an independent medical doctor (trial guardian) as soon as possible after enrolment.
When included in the study, patients will be randomized 1:1 centrally in the RedCap system, using a computer-generated concealed assignment sequence, with permuted blocks of varying sizes, to start with either the intervention (APRV) followed by control (volume controlled mechanical ventilation) or control followed by intervention.
Esophageal manometry will be used as a surrogate to measure the transpulmonary pressure. Arterial blood gasses, blood samples and lung ultrasound will be used to investigate oxygenation, ventilation and aeration.
Treatment targets for both groups during the study are pH >7.20, saturation ≥ 88% and PaO2 ≥ 8.0 kPa, with FiO2 titrated as low as possible while complying to the oxygenation targets (PaO2 and saturation).
Both arms start with an 'adjustment phase' where the ventilator is adjusted so the respiratory values are within the targets. The intervention adjustment phase is at least 30 minutes. The adjustments will follow standardized protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Admitted to the ICU
- •Invasive mechanical ventilation with FiO2 ≥ 50% OR PaO2-to-FiO2 ratio <20 kPa, including PEEP 3 5 cmH20 for at least 6 hours
排除标准
- •Meeting inclusion criteria for more than 24 hours
- •Severe bronchospasm, defined as warranting treatment aimed at reversing this i.e. inhalation of anticholinergic or bronchodilator beyond what the patient normally use
- •Emphysema where treating physician judges the patient at increased risk for pneumothorax from APRV
- •Restrictive lung disease defined as a pre-admission diagnosis of restrictive lung disease
- •Undrained pneumothorax
- •Hemodynamic instability defined as more than 0.20 microgram/kg/min of norepinephrine or any dose of adrenaline infusion to maintain MAP ≥ 65 mmHg
- •Age < 18 years
- •Patients who have received APRV previously during the current ICU admission
- •Patients in prone position within the last 24 hours
结局指标
主要结局
Median peak transpulmonary pressure
时间窗: During the observation period; 1-6 hours after randomization
Measured with esophageal manometry in cmH20.
次要结局
- Peak PaCO2 in kPa(During observation period; 1-6 hours after randomization)
- Nadir pH(During observation period; 1-6 hours after randomization)
- Proportion of patients with peak transpulmonary pressure > 12 cmH2O(During observation period; 1-6 hours after randomization)
- Lung ultrasound aeration according to LUS(During observation period; 1-6 hours after randomization)
- Change in peak transpulmonary pressure in cmH20(During observation period; 1-6 hours after randomization)
- Fluctuations in transpulmonary pressure in cmH20(During observation period; 1-6 hours after randomization)
- Change in fluctuations of transpulmonary pressure in cmH20(During observation period; 1-6 hours after randomization)
- Peak FiO2 in %(During observation period; 1-6 hours after randomization)
- Nadir PaO2-to-FiO2 ratio(During observation period; 1-6 hours after randomization)
研究者
Theis S. Itenov
Sponsor
University Hospital Bispebjerg and Frederiksberg