跳至主要内容
临床试验/NCT06186557
NCT06186557招募中不适用

Automated Detection of Patient Ventilator Asynchrony Using Pes Signal A Feasibility Study Towards a Detection Algorithm

Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Performance of detection algorithm

研究概览

简要总结

Rationale: Patient-ventilator asynchrony (PVA) in mechanical ventilation is associated with adverse patient outcome such as a prolonged stay in the ICU and even mortality. The prevalence of asynchronies is, however, difficult to quantify. It is common to use only the pressure and flow signal of the ventilator to detect asynchronies. The detection method is often based on definitions. The investigators will use new techniques (esophageal pressure signal and machine learning (ML)) to improve detection and quantification of patient-ventilator asynchronies. The hypothesis is that an algorithm which uses the Pes signal and ML to detect and quantify asynchronies is superior to previous techniques.

Objective: 1. To develop an asynchrony detection algorithm based on pressure, flow and Pes signal using ML. 2. To develop a second algorithm with the same ML technique based on pressure an flow signal only. 3. To compare the performance of these models in comparison with an expert team and with each other.

Study design: The investigators will collect internal data from the ventilator connected to patients on mechanical ventilation (population described below). First, the investigators will, with a dedicated expert team, identify and annotate the asynchronies based on visual inspection of the pressure, flow and Pes signal. Second, the investigators will develop an ML algorithm which will be trained with the annotated data from the visual inspection. Third, the performance of the AI algorithm will be compared with the performance of the expert panel using newly obtained data. Fourth, the performance of the AI algorithm will be compared with the second algorithm which uses the pressure and flow signal only.

Study population: All patients admitted to the adult ICU of the LUMC on mechanical ventilation who are ventilated > 24 hours and are equipped with an esophageal balloon catheter.

Intervention (if applicable): None.

Main study parameters/endpoints: The performance of the detection algorithm.

详细描述

  1. INTRODUCTION AND RATIONALE Mechanical ventilation should unload the respiratory muscles, provide adequate gas exchange and should be safe, i.e., harm due to mechanical ventilation should be reduced to a minimum. To achieve this the interaction between the ventilator and the patient is preferentially synchronous. Ventilator settings not being synchronized with patient respiratory drive or activity is a phenomenon known as patient-ventilator asynchrony (PVA). PVA may induce several deleterious effects.1 Studies have shown asynchronies to be associated with patient discomfort, increased work of breathing, prolonged weaning, and in one study, even increased mortality.

Monitoring PVA however is difficult. Clinicians often have to rely on physical examination of the patient as well as visual inspection of pressure, flow and volume waveforms to identify an asynchrony.6 The sensitivity and positive predictive value of analyzing breath-to-breath waveforms are very low (22% and 32%, respectively).1 Artifacts such as cardiac oscillation may mimic asynchronies, and there are times when clinicians standing at the bedside are unable to distinguish between asynchronies and artifacts with certainty.6 Furthermore, detection of PVA is dependent of bedside examination. This challenge leads to the desire of developing effective automated PVA recognition algorithms.7 Various automated algorithms have been developed, however with a variable performance.1 For a correct analysis of asynchronies, the use of an esophageal balloon catheter, which measures the esophageal pressure (Pes), or a catheter which measures the electrical activity of the diaphragm, is necessary.1 Since the use of Pes catheters, it is possible to describe other forms of PVA, such as reverse triggering, which is an asynchrony in which the ventilator triggers the patient.8 Until recently, however, the esophageal catheter has not been routinely used in daily practice but more as a research tool. Since the introduction of personalized medicine, clinicians have gained interest in esophageal manometry to better titrate care to the unique physiology of a patient.9 There are in the current literature no reports of PAV detection algorithms that use the Pes signal for detection.

In the LUMC the investigators use the esophageal catheter in all patients admitted with acute respiratory failure and in patients ventilated for more than 48 hours per protocol. The esophageal signal gives the opportunity to detect asynchronies more easily than without. The investigators therefore hypothesize that an algorithm based on the esophageal signal will perform better than an algorithm that only uses other ventilator waveforms. 2. OBJECTIVES 2.1 Primary Objective The primary objective of this study is to develop an asynchrony detection algorithm based on pressure, flow and Pes signals of patient data using ML.

2.2 Secondary Objectives Secondary objectives are to validate the detection algorithm by comparing its performance with the assessment of the expert panel and to compare its performance with the performance of a second algorithm which is based on pressure- and flow signals only. 3. STUDY DESIGN This study will take place at the Intensive Care Unit of the LUMC. First, internal data of adult ICU patients on mechanical ventilation because of acute respiratory failure or with a ventilation duration of at least 24 hours and that are equipped with an esophageal balloon catheter will be collected from the ventilator. The data of interest include pressure, flow and Pes signals of the ventilation. It is necessary to collect as much data as possible as this is required for the development of the algorithm. A minimum of 50 patients will be included with from each a ventilation recording between 4 and 8 hours, which amounts to 200 - 400 hours of mechanical ventilation recording.

The following labels will be assigned to the data:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • admission to the ICU of the LUMC;
  • age of 18 years or older;
  • intubated and receiving mechanical ventilation because of acute respiratory failure or with a ventilation duration of at least 24 hours; and
  • equipped with an esophageal balloon catheter

排除标准

  • after recent pneumectomy or lobectomy;
  • no informed consent

结局指标

主要结局

Performance of detection algorithm

时间窗: 8 hours

Model evaluation: The first part of the dataset will be used to construct/train the model. The second part of the dataset will be used to evaluate the performance of the model. The labels attained by the experts are considered the ground truth. The labeling of the algorithm will be compared with the labels of the experts to assess the performance of the algorithm. The performance of the primary algorithm will be compared with the performance of the second algorithm, which is based only on pressure and flow signals. The performance of the second algorithm will be assessed as described above. The agreement between the experts will be assessed using Fleiss's kappa, which evaluates the agreement between more than two raters.

次要结局

未报告次要终点

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abraham Schoe, MD, PhD.

MD, PhD

Leiden University Medical Center

研究点 (1)

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