High-assistance Proportional Assist Ventilation (PAV) vs. Assist-Control Ventilation (ACV) in Early Stage of Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Length of mechanical ventilation
研究概览
简要总结
To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+) (objective 80% gain) as main ventilatory support in early stage of critically ill patients in comparison with standard volume-assist control ventilation (ACV).
详细描述
The goal of this proposal is to apply PAV+ as routine ventilatory mode in the early stage of critically ill patients, taking advantages of spontaneous breathing and better patient-ventilator interaction.
The standard treatment in patients with acute respiratory failure is mechanical ventilation in control-mode for the first days of acute illness. This procedure is usually associated with patient-ventilator dyssynchrony, higher needs of sedation and/or relaxation, muscle atrophy, etc. PAV + is a new ventilatory mode that applies pressure in proportion to spontaneous patient inspiratory effort allowing better adaptation to changes in internal homeostasis.
Up to now, several reports compare PAV with assisted modes as a feasible alternative only in the weaning phase. However, PAV is able to unload patient effort in different levels, suggesting that high-assistance PAV (about 80%) could be comparable with assist-control modes in terms of respiratory muscles unload.
Whether PAV is as effective as traditional ACV in terms of ventilation muscle unload in the acute phase of illness has not been established and we aim to address this question.
We plan to prospectively enroll patients on mechanical ventilation early at ICU admission, and to ventilate them randomly under ACV (volume-assist control ventilation) or PAV+ (beginning with 80% if possible). We will evaluate length of mechanical ventilation, sedation requirements and respiratory-hemodynamic variables from the very beginning and until attending clinicians decide that patients are ready to be weaned.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •Anticipated MV > 24 hours
- •Availability of informed consent from patient or next of kin
- •Ventilation parameters measured under PAV+ 80% gain:
- •PaO2/FiO2 >100 RPAV <10 cm H2O/l/s CPAV > 30 ml/cm H2O WOBTOT <1.5 J/l VE <18 l/min
排除标准
- •Patients on moribund state or with life-sustaining therapy withholding decision.
- •Patients with unstable respiratory/hemodynamic state, PaO2/FiO2 <100, Dopamine >15 microg/Kg/min or epinephrine >0.1 microg/kg/min.
- •Pregnancy.
- •Air leak.
- •Patients needing deep sedation or muscle paralysis
- •Patients needing hyperventilation (brain trauma).
- •Patients with severe muscle weakness.
- •Recruitment maneuvers or prone position.
结局指标
主要结局
Length of mechanical ventilation
时间窗: 28 days
Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.
次要结局
- Non-inferiority of PAV+ compared to ACV in terms of gas exchange(28 days)
- Noninferiority of PAV in short term complications(28 days)
- Noninferiority of PAV in weaning success(28 days)
研究者
Rafael Fernandez
Head of Intensive Care Department
Althaia Xarxa Assistencial Universitària de Manresa