Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • ACLS
  • Cardiac Arrest
  • Cardiopulmonary Arrest With Successful Resuscitation
  • Echocardiography, Transesophageal
  • Image Guided ACLS
  • in Hospital Cardiac Arrest
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Convenience Sampled, Prospective Arm1: Conventional ACLS Arm2: Image Guided RescueTEE ACLSMasking: Double (Care Provider, Outcomes Assessor)Masking Description: Conventional ACLS and Rescue TEE ALCS patients after codes will be observed for survival. Care teams will be blinded to the methodology of ACLS. A post-hoc analysis will also be performed for independent ECHO reads.Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Rescue transesophageal echocardiography (RescueTEE) is an unplanned ultrasound examination performed on an urgent or emergent basis to diagnose causes of unexpected hemodynamic instability or cardiopulmonary arrest. The indication for RescueTEE is generally based on the individual patient's conditio...

Rescue transesophageal echocardiography (RescueTEE) is an unplanned ultrasound examination performed on an urgent or emergent basis to diagnose causes of unexpected hemodynamic instability or cardiopulmonary arrest. The indication for RescueTEE is generally based on the individual patient's condition rather than a specific surgical or interventional procedure. Point of care (POC) ultrasound is an imaging methodology performed at the bedside, which allows clinicians to rapidly identify life-threatening pathology in patients who are too critically ill to await formal echocardiography or transport to the echo lab. POC ResuceTEE is a developing area within anesthesiology, critical care and emergency medicine, which provides real time information to help guide therapeutic interventions at the bedside. There are several patients who may benefit from TEE imaging, as opposed to transthoracic echocardiography (TTE), due to underlying structural, functional, or ischemic cardiovascular pathology that is more readily seen on TEE. Due to a variety of technical, logistical (machine positioning, proceduralist location) and/or patient related factors including obesity, during on-going cardiopulmonary resuscitation (CPR), open chest, recent sternotomy, and pulmonary edema; TEE is favored over TTE. Factors such as the patient's disease process and anticipated diagnostic dilemmas are considered when deciding which patients will benefit from RescueTEE. Since 2008, 4 studies describing transesophageal echocardiography use during cardiac arrest by emergency medicine providers have demonstrated its feasibility and advantages in this environment. The American Heart Association (AHA) guidelines for treating cardiac arrest are based on information from the pulse check and rhythm analysis to guide treatment; both of which have been shown to be error prone. In some studies, the accuracy of the pulse check has been as low as 15% when limited to the 10 seconds permitted for a pulse check. Multiple studies have shown discrepancy when comparing the rhythm observed by ECG with that observed by echocardiography, with one study finding that 35% of patients thought to be in asystole had coordinated cardiac contractility. Most recently the REASON Trial by Gaspari et al. in 2017 assessed 225 patients in PEA cardiac arrest with cardiac activity on TTE. They concluded that TTE guidance that identified organized cardiac activity that was treated with continuous adrenergic intervention resulted in better survival. They therefore concluded that TTE could help identify a subset of patients in PEA that may respond differently to ACLS interventions. This study will use a recently published and validated POC focused 4-view RescueTEE evaluation for patients in shock, cardiac arrest, respiratory arrest, anesthesia stat evaluation, or those patients requiring bedside mechanical circulatory support to obtain diagnostic and therapeutic information to aid in medical decision-making in a rapid fashion for those patients who are experiencing in-hospital arrest. The reason for using a validated published RescueTEE protocol is to study the outcome effects of an effective intervention that is publicly available. The goal of the study will be to study how RescueTEE information can help guide the code leader for management decision-making and improve in-hospital mortality outcomes. We further hope to assess if TEE guidance of therapies or interventions can result in improved peri-arrest outcomes. This is an interventional prospective convenience sampled study looking at outcomes comparing RescueTEE image guided ACLS versus conventional ACLS.

Tracking Information

NCT #
NCT04220619
Collaborators
Not Provided
Investigators
Principal Investigator: Jacob Gutsche, MD University of Pennsylvania, Department of Anesthesiology and Critical Care Principal Investigator: Asad A Usman, MD, MPH University of Pennsylvania, Department of Anesthesiology and Critical Care