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临床试验/NCT04274296
NCT04274296已完成不适用

Advisory Lead ARDS Respirator Management

Mathias Maleczek1 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2020年9月1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
472
试验地点
1
主要终点
Change of AUC of driving pressure

研究概览

简要总结

A advisory will be activated in the ICUs patient data management system. The trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. In a second phase during the next six months, all patients with a LIPS ≥ 4 will be included into the advisory group where advisories will be shown in the patient data management system.

To create this advisory, a clinical advisory rule is executed every 4 hours and the appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥ 15mbar) are reached, then the advisory displays a recommendation to rethink the patient's ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%)

详细描述

Background Lung protective ventilation is a well-established treatment to reduce ventilator-induced lung injury (VILI) in patients suffering from ARDS. To quantify lung protective ventilation the concept of driving pressure (ΔP) and mechanical power were postulated.

Although low tidal volumes and low driving pressures are considered standard of care, it was shown that lung protective ventilation is very little used in ICU patients. Especially in those with a less severe lung disease.

Automated Clinical Decision Support (CDS) systems are gaining more attention in clinical practice. They have been successfully used to increase medical provider adherence to guidelines or local department policy. Another successful means of influencing behavior of medical providers are so called nudge-based interventions. Currently there is little evidence on nudge-type interventions or automated alerts for ventilator settings in the ICU. To our knowledge studies that linked these interventions to a change in patient's outcome are lacking.

Hypothesis Activation of an advisory in the patient data management system accompanied by educational sessions and feedback emails decrease ventilation driving pressure in mechanically ventilated patients at increased risk of ARDS (LIPS ≥ 4). As secondary outcome parameters, incidence of ARDS, ventilator free days, reintubation rate, length of stay in the ICU or the hospital and mortality at day 28 will be evaluated.

Methods As an advisory is activated in the ICU software, medical staff caring for the patients can't be blinded. Therefore, the trial will be conducted as observational cohort trial. During the first six month all patients with a LIPS ≥ 4 will be included in the control group. No change of care is needed. In a second phase during the next six months, all patients with a LIPS ≥ 4 will be included into the alert group where advisories will be shown in the patient data management system.

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 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • LIPS >= 4, ventilated invasively at point of screening

排除标准

  • ARDS at admission
  • Pregnant patients
  • Age < 18 years
  • Patients with elevated intracranial pressure

结局指标

主要结局

Change of AUC of driving pressure

时间窗: 10 days

The driving pressure will be used to create a graph; The AUC will be calculated for each patient. Changes in AUC will be used as measurement for driving pressure over time.

次要结局

  • 28-day mortality, 90-day mortality and one-year mortality(1 Year)
  • Change in ARDS incidence(Day 1-28)
  • Change in ventilator free days(Day 1-28)
  • Reintubation rate due to respiratory failure(Day 1-28)
  • Reduction of mechanical power(Day 1-10)

研究者

发起方
Mathias Maleczek
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mathias Maleczek

Registrar

Medical University of Vienna

研究点 (1)

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