RescueTEE for In-hospital Cardiac Arrest (ReTEECA Trial)

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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

      ReTEECA Trial. Rescue TransEsophageal Echocardiography for In-Hospital Cardiac Arrest.

      This trial is aimed at studying the utility and interventional outcomes of rescue
      transesophageal echocardiography (RescueTEE) to aid in diagnosis, change in management, and
      outcomes during CPR by using a point of care RescueTEE protocol in the evaluation of
      in-hospital cardiac arrest (IHCA). This is an interventional prospective convenience sampled
      partially blinded phase II clinical trial with primary outcomes of survival to hospital
      discharge (SHD) with RescueTEE image guided ACLS versus conventional ACLS.
    

Detailed Description

      This is a Phase II, single center, partially blinded, prospective, safety and efficacy
      pragmatic clinical trial comparing rescue transesophageal image guided ACLS versus
      conventional ACLS in adult patients with in-hospital cardiac arrest (IHCA). The ReTEECA Trial
      will use a recently published and validated focused 5-view RescueTEE protocol to evaluate
      patients with IHCA 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.1 Patients will be resuscitated with one of the following protocols:

        1. Conventional ACLS with RescueTEE during IHCA. The TEE probe will be brought to the IHCA
           code call and placed within 10 minutes of cardiac arrest after a secured airway has been
           obtained. The RescueTEE team led by a physician (RescueTEE MD) and will use a predefined
           protocol for diagnosis and if needed intervention at the discretion of the treating
           physician (Code Team MD). If an intervention is performed this will be done at the
           discretion of the treating physician as a pragmatic and clinically evidenced
           intervention. The TEE probe will remain indwelling for 30 minutes or until return of
           spontaneous circulation (ROSC) whichever is earlier.

        2. Conventional ACLS without RescueTEE during IHCA. Conventional ACLS will be driven by
           national American Heart Association (AHA) standardized protocols by the treating
           physician (Code Team MD) and code team members.

      Management of the patient and ACLS will be driven pragmatically and by the local code team
      (Code Team MD) and not the RescueTEE team. Advice and diagnostic evidence, as able, from the
      RescueTEE will be provided by the RescueTEE team (RescueTEE MD). Post ROSC care will be at
      the discretion of the ICU team (ICU MD). The indications for using a validated published
      RescueTEE protocol is to study the outcome effects of an intervention that is publicly
      available and apply this in a real-world clinical scenario as a prospective trial.

      Based on our preliminary results we hypothesize that routine use of RescueTEE guided ACLS for
      IHCA will expedite diagnosis, treatment, intervention, and facilitate and identify reversible
      causes and significantly improve survival to hospital discharge and in turn functional
      survival compared to standard ACLS.

      Given the poor clinical outcomes of IHCA it is imperative to conduct research in this area.
      RescueTEE provides an avenue to help diagnose and clinically intervene on pathology during
      the intra-arrest period. This directly impacts the disease process, the patient, and will
      likely change ACLS management. There are studies that have been conducted retrospectively and
      prospectively that highlight the benefits of image guidance during ACLS; however, no
      randomized clinical trial documenting the safety and efficacy of RescueTEE has been
      conducted. Many institutions and hospital systems are now using RescueTEE during ACLS;
      however, we do not know the impact that this has had directly on survival and complications.
      Like many areas in medicine, a prospective clinical trial can help elucidate the direct
      patient benefits in terms of survival. This will offer future researchers a platform to
      conduct further studies on image guidance during ACLS. A prospective clinical trial is
      necessary to transform national guidelines and help guide evidence-based practice throughout
      the country.

      ReTEECA Trial Hypothesis: Based on our preliminary results we hypothesize that routine use of
      RescueTEE guided ACLS for IHCA will expedite diagnosis, treatment, intervention, and
      facilitate and identify reversible causes and significantly improve survival to hospital
      discharge and in turn functional survival compared to standard ACLS.

      ReTEECA Trial: We propose a Phase II, single center, partially blinded, intention to treat,
      safety and efficacy clinical trial to assess the results of routine RescueTEE guided ACLS for
      IHCA compared with standard ACLS. The Hospital of the University of Pennsylvania and the
      Department of Anesthesiology and Critical Care has the patient population, experience,
      expertise, and infrastructure to execute the proposed study.

      Specific Aims: The goal of the study will be to use intra-arrest RescueTEE diagnostic imaging
      to guide the code leader in clinical management and decision-making and to therefore decrease
      IHCA mortality rates. Additionally, we will assess if RescueTEE guidance of intra-arrest
      therapies or interventions can significantly improve functionally favorable outcomes.
    


Study Type

Interventional


Primary Outcome

Survival

Secondary Outcome

 Number of patients surviving to End of ACLS

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

November 1, 2021

Completion Date

December 1, 2024

Primary Completion Date

July 1, 2024

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

832882


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

September 2021