Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Airway Occlusion Pressure
研究概览
简要总结
Mechanical ventilation is essential in the management of patients in Intensive Care. The approach to patients with prolonged weaning is challenging.In this context, it is vital to implement "diaphragmatic protection" strategies, which consist of programming the level of ventilator assistance focused on sustaining the muscular effort within an objective range. The reference method for measuring inspiratory effort is the Pressure-Time Product (PTP) of the esophagus.
Recently, Bertoni et al. proposed the measurement of Occlusion Pressure as a non-invasive method, without the need to assess esophageal pressure, to estimate the magnitude of the effort and program assistance. Although it is a validated measurement for quantifying effort, it does not consider the duration of the effort performed by the patient, as well as the respiratory rate, two fundamental variables in terms of tolerance to the load. Therefore, the investigators propose the following study that will seek to validate the measurement of PTP in from the Occlusion Pressure, but considering inspiratory time and respiratory rate to obtain PTP per breath and per minute.
详细描述
Mechanical ventilation (MV) is an essential support in the management of patients in Intensive Care Units (ICU). According to international epidemiological studies, around 40% of patients admitted to ICU require ventilatory support.
International epidemiological data indicate that just over 55% of ICU patients are weaned from MV prematurely, and that approximately 20% experience difficult and prolonged weaning. In Argentina, our country, there are reports that this population amounts to 49.3%. One common denominator in the literature, international and national, regarding this section, is that such patients have more days of MV, ICU and hospital stay.
During prolonged weaning, monitoring of muscular effort becomes essential: both excessive and deficient efforts usually lead to diaphragmatic dysfunction. The former predisposes to fatigue, while the latter to atrophy. In this context, it is vital to implement "diaphragmatic protection" strategies, which consist of programming the level of assistance with a focus on muscular effort or muscular pressure (PMUS) to keep it within a target range.
The reference method for measuring inspiratory effort is the Pressure-Time Product of the esophagus (PTPESO), which involves the magnitude of PMUS measured through the change in esophageal pressure (PES) generated during inspiration, its duration, and respiratory rate (RR). For patients on partial ventilatory support, a PTP of 50 to 150 cmH2O/sec/min is recommended. Thus, PES becomes an everyday and reference tool for the management of patients with prolonged weaning from MV.
Recently, Bertoni et al. proposed measuring Occlusion Pressure (POCC) as a non-invasive method, i.e., without the need to evaluate PES, to estimate the magnitude of PMUS and program assistance in PSV. By means of a tele-expiratory occlusion maneuver of the airway, the maximum negative deflection of the signal during the patient's inspiration is quantified. This maneuver is called POCC. Then, through a simple multiplication by a constant, the value of PMUS in one cycle is obtained. Given the ease of measurement and its non-invasive nature, this technique has taken a leading role in the approach to patients during partial support at present.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with mechanical ventilation, who failed 3 or more spontaneous breathing trials
- •Esophageal balloon placed
- •Who can trigger the ventilator
- •With hemodynamic stability
- •with P/F ratio above 150
排除标准
- •under 18 years old of age
- •pregnancy
- •do not resuscitate order or expected poor short term prognosis
- •refuse to sign the informed consent
结局指标
主要结局
Airway Occlusion Pressure
时间窗: At the end of the study, estimated in July 2024
An inspiratory pressure will be set to obtain a muscular pressure value of 8 to 12 cmH2O. This phase will be called PSV100%. After 15 minutes, the level of assistance will be modified by 50%, up or down, according to the result of the randomization, and vice versa, always considering the initial value. Each of these phases will be called PSV150% and PSV50% respectively, and will last 15 minutes. During the last 3 minutes, 3 end-expiratory occlusion at a rate of 1 maneuver per minute will be performed, in order to obtain the airway Occlusion Pressure.
次要结局
- Esophageal Pressure Time product per breath (PTPESOF-br) and per minute (PTPESOF-min)(At the end of the study, estimated in July 2024)
研究者
EMILIO MARTIN STEINBERG
Principal Investigator
Hospital Italiano de Buenos Aires
