RescueTEE for In-hospital Cardiac Arrest (ReTEECA Trial)

Not Applicable

Withdrawn

• Conditions: ACLS; In-hospital Cardiac Arrest; Cardiac Arrest; Image Guided ACLS; Echocardiography, Transesophageal; Cardiopulmonary Arrest With Successful Resuscitation
• Interventions: Diagnostic Test: Tranesophageal Echocardiography

• Registration Number: NCT04220619
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2020-01-04
• Study First Posted: 2020-01-07
• Study Start: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RescueTEE guided ACLS	Tranesophageal Echocardiography	Patients who have RescueTEE guided ACLS

Primary Outcome Measures

Name	Time	Method
Survival	3 months	Survival to hospital discharge (SHD) - Survival is the most widely accepted endpoint in CPR and CA trials. Our trial is designed to evaluate the effect of imaging and RescueTEE guided ACLS in order to facilitate survival.

Secondary Outcome Measures

Name	Time	Method
Neurologically Intact Survival at 3 months	3 months	Neurologically intact survival based on modified Rankin's Score at 3 month
Number of patients surviving to End of ACLS	1 hour	Count of patients surviving to End of Code
Number of patients surviving to 30 days	30 days	30 days survival for image guided RescueTEE ACLS versus conventional ACLS
Number of patients surviving to ICU discharge	Variable	Count of patients surviving to ICU discharge
Neurologically Intact Survival at 6 months	6 months	Neurologically intact survival based on modified Rankin's Score at 6 month