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临床试验/NCT07637240
NCT07637240尚未招募不适用

CRUISE Blinded STAT Helicopter Study

Hernando Gomez0 个研究点目标入组 60 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60

研究概览

简要总结

This is a prospective, observational, blinded clinical study with the purpose of assessing the safety of a non-invasive decision support system for the identification and management of shock (the CRUISE system). Researchers will compare the recommendations provided by the CRUISE system with those executed as part of the standard of care by transport paramedics and medics in acute ill adult critically ill patients in shock or requiring active resuscitation being transported by helicopter (STAT MedEvac) to Presbyterian Hospital.

Planned total enrollment is 60 patients.

详细描述

The objective is to compare the performance of the CRUISE system compared to the actions executed by the critical care transport teams during the resuscitation of patients with shock or in need of active resuscitation while being transported from the field or outside hospitals to all core hospitals in the UPMC system (Presbyterian, Shadyside, Mercy and Passavant Hospitals). Specifically, focus on safety, which will define in several domains including (i) a comparison of the recommendations of the CRUISE system and the actions executed by the transport team, (ii) the differences in dose of blood, crystalloids and vasopressors between the two, (iii) the presence of artifacts in the monitoring systems leading to false positives or false negatives with both the CRUISE system and medical team, and (iv) the difference in time to intervention between the medic team and CRUISE recommendations. Researchers hypothesize that the recommendations provided by the CRUISE system will lead to faster interventions, with less fluid and lower levels of norepinephrine than the resuscitation driven by the transport teams.

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

入选标准

  • All adult patients with signs of shock evaluated, treated, and/or transported by Emergency Medical Services under medical oversight of UPMC EMS Medical Directors and/or arriving at UPMC facilities with which the PI and Co-investigators routinely have access to the records.

排除标准

  • Age < 18 years
  • Active atrial fibrillation or irregular rhythm
  • Open chest
  • Known right ventricular failure

研究组 & 干预措施

Observational Blinded Group

干预措施: Observation blinded group with the purpose of assessing the safety of a non-invasive decision support system for the identification and management of shock (the CRUISE system). (Device)

研究者

发起方
Hernando Gomez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hernando Gomez

Associate Professor

University of Pittsburgh

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