RescueTEE for In-hospital Cardiac Arrest (ReTEECA Trial)

Brief Title

RescueTEE for In-hospital Cardiac Arrest (ReTEECA Trial)

Official Title

Rescue Transesophageal Echocardiography for the Guidance of Cardiopulmonary Resuscitation for In-hospital Cardiac Arrest Versus Conventional ACLS

Brief Summary

      This is an interventional prospective study comparing image guided ACLS using RescueTEE
      versus conventional ACLS. This protocol will study and determine the utility of rescue
      transesophageal echocardiography (RescueTEE) to aid in point-of-care diagnosis, change in
      management, guidance of ACLS, and outcomes after ACLS. It will employ a standardized code
      script and imaging RescueTEE protocol in the evaluation of patients in shock, cardiac arrest,
      respiratory arrest, or those patients requiring bedside mechanical support in the hospital
      setting.
    

Detailed 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 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.
    


Study Type

Interventional


Primary Outcome

ROSC

Secondary Outcome

 Optimal Hand Positioning

Condition

Echocardiography, Transesophageal

Intervention

Tranesophageal Echocardiography

Study Arms / Comparison Groups

 Conventional ACLS
Description:  Patients who have conventional ACLS during in-hospital Cardiac arrest, they will not have RescueTEE

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

250

Start Date

May 1, 2020

Completion Date

December 1, 2022

Primary Completion Date

July 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  All patients greater than 18 years of age;

          -  Intubated or permanent tracheostomy in situ;

          -  Experiencing extreme hemodynamic instability, cardiac arrest, or respiratory arrest
             and TTE is difficult or contraindicated

          -  Rapid response, Code calls, ECMO stat evaluation

          -  In-patients

        Exclusion Criteria:

          -  Unsecured airway

          -  On-going aspiration

          -  History of tracheoesophageal injury

          -  History of tracheoesophageal fistula

          -  Esophagectomy

          -  Active upper GI bleeding

          -  Esophageal varices

          -  Ongoing hemoptysis

          -  Technically challenging TEE placement due to location of code - Small room, intrusive
             to the code team, airway trauma
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jacob Gutsche, MD, 2676027025, [email protected]



Administrative Informations


NCT ID

NCT04220619

Organization ID

1234567


Responsible Party

Principal Investigator

Study Sponsor

University of Pennsylvania


Study Sponsor

Jacob Gutsche, MD, Principal Investigator, University of Pennsylvania, Department of Anesthesiology and Critical Care


Verification Date

March 2020