COMPARISON OF LUNG RECRUITABILITY ASSESSMENT BY HYSTERESIS RATIO AND RECRUITMENT-TO-INFLATION RATIO AND THE USE OF DIFFERENT PEEP TITRATION METHODS IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Agreement between the hysteresis ratio and the recruitment-to-inflation (R/I) ratio for assessing lung recruitability
研究概览
简要总结
This multicenter, single-blind physiological study aims to compare two bedside methods for assessing lung recruitability in mechanically ventilated patients with acute respiratory distress syndrome (ARDS): the recruitment-to-inflation (R/I) ratio and the pressure-volume (PV) loop hysteresis ratio. Lung recruitability will be defined according to the reduction in lung collapse measured by electrical impedance tomography (EIT) during a standardized lung recruitment maneuver.
Following baseline measurements, participants will undergo sequential physiological assessments, including lung recruitability evaluation using both the R/I ratio and a low-flow PV loop, a standardized lung recruitment maneuver with a decremental PEEP trial, and a second PV loop performed at a lower maximum inflation pressure. The order of the R/I ratio assessment and the PV loop maneuver will be randomized.
In a final crossover phase, four different PEEP titration strategies will be evaluated in randomized order. Each strategy will be applied for 15 minutes and separated by a washout period at the patient's baseline clinical PEEP. Respiratory mechanics, gas exchange, ventilation/perfusion distribution, and hemodynamic variables will be assessed throughout the protocol.
The primary objective is to determine the agreement between the hysteresis ratio and the R/I ratio for identifying lung recruitability. Secondary objectives include evaluating whether a PV loop performed with a lower maximum pressure provides similar information on recruitability and comparing the physiological effects of different PEEP titration strategies. Approximately 30 patients with moderate-to-severe ARDS receiving invasive mechanical ventilation will be enrolled.
详细描述
Acute respiratory distress syndrome (ARDS) is a severe form of respiratory failure that requires mechanical ventilation. One of the main challenges in ventilator management is selecting the optimal level of positive end-expiratory pressure (PEEP), as patients differ in their potential for lung recruitment. Individualizing PEEP may help improve lung protection by reducing lung collapse while avoiding overdistension. The study is designed to improve the understanding of bedside tools for assessing lung recruitability and to evaluate their potential role in personalizing mechanical ventilation in patients with ARDS.
Patients meeting the inclusion criteria will be enrolled in this multicenter, single-blind physiological study after informed consent has been obtained. Continuous monitoring will include electrical impedance tomography (EIT), esophageal pressure, mechanical ventilation parameters, end-tidal carbon dioxide, and standard hemodynamic monitoring throughout the study protocol.
After enrollment, a fluid responsiveness assessment will be performed using a standardized tidal volume challenge to optimize hemodynamic conditions before study interventions. Baseline measurements will then be obtained after 15 minutes at the patient's clinical ventilator settings and will include respiratory mechanics, arterial blood gases, ventilation/perfusion (V/Q) analysis, and hemodynamic variables.
The primary endpoint is the comparison between the hysteresis ratio and the recruitment-to-inflation ratio for the assessment of lung recruitability, using the reduction in lung collapse measured by EIT as the reference standard. Secondary endpoints include comparison of recruitability assessment obtained with PV loops performed at maximum inflation pressures of 40 and 30 cmH₂O, and evaluation of the physiological effects of different PEEP titration methods on respiratory mechanics, ventilation/perfusion matching, gas exchange, and hemodynamics. Clinical outcomes, including duration of mechanical ventilation, ICU and hospital length of stay, and mortality, will also be recorded.
The first study phase evaluates lung recruitability using two bedside methods: the recruitment-to-inflation (R/I) ratio and a low-flow pressure-volume loop with a maximum pressure of 40 cmH₂O (PVloop40). The order of these two assessments will be computer-randomized. During the R/I assessment, measurements will be obtained at PEEP levels of 5 and 15 cmH₂O, followed by a single-breath maneuver to calculate the recruitment-to-inflation ratio. The PVloop40 maneuver will be used to calculate the hysteresis ratio from the inspiratory and expiratory limbs of the pressure-volume curve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Intubated patients with acute respiratory distress syndrome (ARDS): PaO2/FiO2 ratio <200, with bilateral infiltrates of non-cardiogenic origin, with a PEEP of at least 5 cmH2O.
- •The patient is receiving mechanical ventilation and continuous sedation.
- •The patient has an esophageal balloon.
- •Written informed consent signed and dated by the patient or one relative in case the patient is unable to consent, after a full explanation of the study by the investigator and prior to study participation
排除标准
- •Patients with< 18 years old
- •Pregnant woman
- •Lung recruitment maneuvers are deemed unsafe by the medical team
- •Unable to fit EIT belt due to patient size
- •Contraindications to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)
- •Hemodynamic instability (Systolic BP < 75 mmHg or MAP < 60 mmHg despite vasopressors and/or heart rate < 55 bpm)
- •Hypernatremia (Na+ >145mEq/L)
- •The formalized ethical decision to withhold or withdraw life support
- •Patient under guardianship
- •Patients deprived of liberties
- •Impossibility to give informed consent by both patient and family (i.e. language barrier)
- •Patient was already enrolled in the present study in a previous episode of acute respiratory failure.
结局指标
主要结局
Agreement between the hysteresis ratio and the recruitment-to-inflation (R/I) ratio for assessing lung recruitability
时间窗: During the study procedure (approximately within 2-3 hours after enrollment).
Agreement between lung recruitability assessed by the hysteresis ratio obtained from the pressure-volume loop and the recruitment-to-inflation (R/I) ratio, using the reduction in lung collapse measured by electrical impedance tomography (EIT) during the recruitment maneuver as the reference standard.
次要结局
- Agreement between PVloop30 and PVloop40 for the assessment of lung recruitability(During the study procedure.)
- Respiratory mechanics and ventilation/perfusion (V/Q) changes according to different PEEP titration methods(During the study procedure, after 15 minutes of each randomized PEEP titration strategy)
研究者
Oriol Roca
Head of the Intensive Care Unit
Parc Taulí Hospital Universitari
