跳至主要内容
临床试验/NCT04972526
NCT04972526招募中不适用

Evaluation of the Clinical Impact and Safety of Focused Transesophageal Echocardiography During Resuscitation of Critically Ill Patients in the Emergency Department and Intensive Care Settings

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
The clinical impact and safety of TEE performed during the evaluation of critically ill patients in the emergency department and intensive care settings.

研究概览

简要总结

The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE.

The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings.

The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.

详细描述

Vision

The Resuscitative TEE Collaborative Registry aims to accelerate the development of outcome-oriented research and knowledge translation on the use of TEE in emergency and critical care settings.

Mission

The registry aims to catalyze clinical research involving the use of TEE in critically-ill patients through the following strategic initiatives:

  • Facilitate collaboration between different clinical teams and organizations across the entire spectrum of users of TEE in acute care setting, including emergency departments and intensive care units.
  • Standardize data collection and reporting that enables multi-institutional data sharing.
  • Provide an efficient research infrastructure that facilitates data capture, management and analysis, enabling teams around the world to conduct research studies in this field.
  • Make shared data open and accessible to clinicians and researchers.

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

入选标准

  • Adult critically-ill patients who as part of their routine clinical care receive focused TEE in the emergency department of intensive care setting.

排除标准

  • Children (age under 18 years)
  • Vulnerable populations

研究组 & 干预措施

Out-of-hospital Cardiac Arrest

Patients receiving TEE as part of their clinical evaluation during cardiac arrest that occurred outside the hospital (e.g. in/at a home or residence, in a public area, during transport to the emergency department, etc.)

Hemodynamic Monitoring in a Critically Ill Patient

Critically ill patients receiving TEE as part of hemodynamic monitoring

In-hospital Cardiac Arrest

Patients receiving TEE as part of the clinical evaluation during cardiac arrest that occurred within a hospital (e.g in the emergency department, an Intensive Care Unit, a hospital ward, the operating room, etc.)

Undifferentiated Shock or Acute Hemodynamic Decompensation

Patients receiving TEE as part of the initial evaluation of undifferentiated shock or acute hemodynamic decompensation

Procedural Guidance

Patients receiving TEE as a means to assist providers performing procedures (e.g. intravenous pacemaker placement, veno-arterial or veno-venous extracorporeal membrane oxygenation [ECMO], impella heart pump placement, intra-aortic balloon pump placement, etc.)

结局指标

主要结局

The clinical impact and safety of TEE performed during the evaluation of critically ill patients in the emergency department and intensive care settings.

时间窗: From the time of admission to the hospital until the date of discharge from the hospital or date of death from any cause, whichever occurs first, assessed up to 12 weeks

Determination of ROSC and survival to hospital discharge

次要结局

  • The use of the TEE imaging modality in subsets of critically-ill patients in shock and cardiac arrest.(From the time of admission to the hospital until the date of discharge from the hospital or date of death from any cause, whichever occurs first, assessed up to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Felipe Teran, MD, MSCE

Chair, Resuscitative TEE Collaborative Registry

Weill Medical College of Cornell University

研究点 (1)

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