Entrainment-Based Mechanical Ventilation to Improve Patient-Ventilator Synchrony
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Feasibility Evaluation
研究概览
简要总结
BACKGROUND AND SIGNIFICANCE Entrainment-based ventilation is a new mode of mechanical ventilation based on the classical physics theory of mutual entrainment between coupled oscillators. Typically, the entrained inspiratory activity may precede or lag behind machine inflation depending on whether spontaneous respiratory frequency is higher or lower than the ventilator frequency.
HYPOTHESIS The investigators anticipate that the results of the study will help to improve the interaction of patients with the mechanical ventilator thereby minimizing the risks of mechanical ventilation in future. The investigators believe the potential benefits significantly outweigh the potential risks.
RESEARCH STUDY DESIGN AND METHODS This is a prospective study and single site. Twenty mechanically ventilated patients, stable on their current vent settings and are capable of triggering the ventilator in the SICU, MICU, CCU and Cardiac and Neuro Surgery ICUs at BWH will be recruited.
After obtaining informed consent a respiratory real-time data monitor will be placed between the artificial airway and the Y piece of the ventilator circuit. Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
DATA COLLECTION Demographic data, weight, height, and past and current medical history will be recorded. Also hospital admission information, reasons of mechanical ventilation, mode of mechanical ventilation and settings, arterial blood gas, clinical laboratory (hematology/chemistry) values, and hemodynamic values will be recorded.
STATISTICAL ANALYSIS Baseline demographic and procedural variables will be analyzed statistically by plotting the 95% confidence intervals of each variable. For feasibility evaluation, the total number of each type of asynchronous breaths/hour during entrainment-based ventilation will be averaged over the 4-hour experimental period and compared with those in the 4-hour baseline ventilation period.
详细描述
BACKGROUND AND SIGNIFICANCE
All currently available mechanical ventilation modes assume that patient-ventilator interaction is necessarily a "master-slave" or controller-follower relationship. In controlled mechanical ventilation, the ventilator takes control of the ventilatory rhythm irrespective of whether the patient is breathing or not. In the patient-triggered mechanical ventilation modes such as assist/control, pressure support ventilation, proportional assist ventilation, neutrally adjusted ventilator support), instead of the ventilator dictating the ventilatory rhythm (ventilator-based ventilation), patient triggering allows the patient to initiate the breath with the ventilator responding to the patients demand (patient-based ventilation) with the imposition of various support.
Entrainment-based mechanical ventilation (EMV) is a new mode of mechanical ventilation based on the classical physics theory of mutual entrainment between coupled oscillators. It takes advantage of the patient's powerful innate capacity to entrain 1:1 to the ventilator rhythm via the Herring-Breuer reflex, provided that the ventilator rhythm is close enough to the spontaneous breathing rhythm. This ability of the respiratory system to adapt to changes in the entrainment mechanism via habituation and desensitization of the Herring-Breuer reflex allows an even greater dynamic range of entrainment.
Justification for the investigation
The investigators anticipate that the results of the study will help to improve the interaction of patients with the mechanical ventilator thereby minimizing the risks of mechanical ventilation in future. We believe the potential benefits significantly outweigh the potential risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult (at least 18 years of age), mechanically ventilated via endotracheal tube, of either sex
- •Capable of triggering the ventilator
- •Subject receiving pressure support ventilation (or assist/control pressure-limited mechanical ventilation) with less than or equal to 15 cm H2O inspiratory pressure, or, if on volume-limited A/C, when switched to pressure-limited A/C with the inspiratory pressure set to match the tidal volume on volume-limited A/C, the resultant inspiratory pressure is less than or equal to 15 cm H2O.
- •Stable on the above-mentioned ventilatory support for at least 8 hours.
- •Arterial line in place for obtaining arterial blood gases
排除标准
- •Requiring high inspiratory oxygen concentration (> 50%).
- •Requiring high ventilatory driving pressure (> 15 cm H20 on pressure-support)
- •High spinal cord injury
- •Immunosuppressed, < 2 months after receiving chemotherapy or radiation therapy.
- •Neuromuscular/ neurological disease of a progressive nature resulting in chronic ventilator dependence.
- •High risk of mortality within 3 months (terminal stage of their disease).
- •Unable to spontaneously trigger the ventilator for any reason.
- •Not considered a candidate for weaning from ventilatory support
- •Consented for another interventional study.
- •Requiring deep sedation and analgesia [Richmond Agitation Sedation Scale -3 to -5 (RASS)]
- •Hemodynamically unstable patients as defined by those requiring norepinephrine at a dose greater than 5 mcg/min or neosynephrine > 100 mcg/min or those with a mean arterial blood pressure < 55 or > 120 mmHg or those with a heart rate < 50 or > 140 bpm.
- •Respiratory rate > 30 breaths/min
- •Pregnancy
研究组 & 干预措施
Patients given EMV Ventilation
Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
干预措施: Patients given EMV Ventilation (Device)
结局指标
主要结局
Feasibility Evaluation
时间窗: 8 Hours
Total number of asynchronous breaths/hour during entrainment-based ventilation compared to baseline ventilation.
次要结局
- Assess for Frequency of Complications Related to the Use of EMV(8 Hours)
研究者
Gyorgy Frendl, M.D., Ph.D.
Associate Professor, Director of Surgical Critical Care Research
Brigham and Women's Hospital