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临床试验/NCT05144607
NCT05144607已完成不适用

Impact of the Display of Inspiratory Muscle Pressure Curves Estimated by Artificial Intelligence on the Ability of Health Care Professionals to Correctly Identify Patient-ventilator Asynchronies - Pmus Study

Hospital Sirio-Libanes2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
105
试验地点
2
主要终点
Ability of ICU health care professionals to detect patient-ventilator asynchrony

研究概览

简要总结

Patient-ventilator asynchronies can occur as a result of a mismatch between neural (patient) and ventilator inspiratory and expiratory phases. Sensitivity of this visual analysis, even when performed by experts in the field, is low, around 28% in one landmark publication. The impact of the display of Pmus together with the other ventilator waveforms on the ability of health-care professionals to identify asynchronies has not been tested so far. OBJECTIVES: To compare the sensitivity and specificity of the detection of patient-ventilator asynchrony by health professionals through visual inspection of the ventilator waveforms (conventional group) with the sensitivity and specificity of health professionals who have available, in addition to these ventilator waveforms, also the estimated inspiratory muscle pressure curve (Pmus group). METHODS: Participants will analyze 49 consecutive different scenarios of mechanical ventilation generated in a simulator. Intensive care unit physicians and respiratory therapist will be invited to participate and after the inclusion will be randomized to one of two groups: 1) the control group will inspect pressure and flow curves and 2) the Pmus group will inspect pressure, flow, and Pmus curves. Before the start of the study, all participants will have a 30-min training session to homogenize their concepts on the definitions of the different types of asynchrony. Subsequently, the participants will be randomized to the conventional group or Pmus group. Participants will be designated to watch different sessions, in groups of at most 20 individuals, according to their randomization. In these sessions, recorded ventilator waveforms will be projected to a large screen for 30 seconds. A still image containing a few ventilatory cycles will remain visible for another 30 seconds when participants will have to choose which asynchrony (if any) the participants can see on the screen. Sessions of the Pmus group will display, in addition to pressure and flow, the estimated muscle pressure curves. The main outcome is the asynchrony detection rate (sensitivity). It will be also compared specificity, positive and negative predictive values for asynchrony detection. Statistical significance will be set at an alpha level of 0.05. The sample size was estimated in 98 participants based on the expectation of a 10 percentage points difference in the sensitivity between groups.

详细描述

The presence of asynchrony was associated with increased mechanical ventilation time, morbidity, reduced hospital discharge rate and IMV free time in the survival analysis, when compared to synchronous patients with the ventilator. Therefore, its correct detection is necessary to optimize ventilatory adjustments and provide a better outcome for patients in the ICU. Recently, the use of software has been proposed with the advantage of being a real-time, automatic and continuous analysis. However these need further studies.

The patient-ventilator interaction is the result of two different pressure systems, the Pmus performed by the patient through the activation of the respiratory muscles and the pressure provided by the mechanical ventilator (Pvent). The tracings, provided by the mechanical ventilator, of pressure and flow are considered a graphical representation of the interaction between Pmus and Pvent, and can exemplify the control of the respiratory cycle by the patient under the influence of the ventilator. The use of these to identify asynchrony, despite being visual and suitable for a logical interpretation, in clinical practice, proved to be dependent on characteristics inherent to the observer, such as length of experience and the presence of previous training. The average sensitivity to correctly identify asynchrony using this interpretation technique was described as 28%, even considering only experienced professionals.

The FlexiMag Max ventilator (Magnamed, São Paulo, Brazil) provides in its interface non-invasively estimated Pmus waveforms through an artificial intelligence algorithm. The Pmus estimate, as it represents the effort performed by the patient both in time and in intensity, when viewed simultaneously with the other waveforms displayed by the ventilator, should provide a more representative graphic portrait of the patient-ventilator interaction. However, the impact of using Pmus estimation on the observer's ability to correctly identify asynchrony has not been studied so far.

Hypothesis The display of the estimated muscle pressure waveform performed by the patient, simultaneously with the pressure and airway flow waveforms over time, will help healthcare professionals in intensive care units to identify patient-ventilator asynchrony.

Methods

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

入选标准

  • Healthcare professionals (physicians and respiratory therapists) who work in intensive care units

排除标准

  • refusal to participate

结局指标

主要结局

Ability of ICU health care professionals to detect patient-ventilator asynchrony

时间窗: Immediately after the completion of the test sessions

The mean sensitivity to detect asynchronies, calculated for each healthcare professional, will be compared between the groups.

次要结局

  • Other measures of diagnostic ability(Immediately after the completion of the test sessions)

研究者

发起方
Hospital Sirio-Libanes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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