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Echocardiography, TransesophagealReTEECANCT04220619

RescueTEE for In-hospital Cardiac Arrest (ReTEECA Trial)

A study testing Tranesophageal Echocardiography in people with Echocardiography, Transesophageal and In-hospital Cardiac Arrest, run by University of Pennsylvania.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Tranesophageal Echocardiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2024to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Unsecured airway
  • On-going aspiration
  • History of tracheoesophageal injury
  • History of tracheoesophageal fistula
  • Esophagectomy
  • Active upper GI bleeding
Show all 9Show fewer
  • Esophageal varices
  • Ongoing hemoptysis
  • Technically challenging TEE placement due to location of code - Small room, intrusive to the code team, airway trauma

About this study

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

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.

Read the 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.

Being tested
Tranesophageal Echocardiography
Keywords
Cardiac Arrest, Transesophageal Echocardiography, CPR, Image Guided CPR, Conventional CPR, RescueTEE
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranesophageal EchocardiographyDiagnostic test

    RescueTEE during ACLS versus Conventional ACLS

Study groups in NCT04220619
Study groupRoleWhat they receive
Conventional ACLSNo interventionPatients who have conventional ACLS during in-hospital Cardiac arrest, they will not have RescueTEE
RescueTEE guided ACLSExperimentalPatients who have RescueTEE guided ACLS
Receives: Diagnostic Test: Tranesophageal Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    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.

    Measured: 3 months

Secondary outcomes (5)
  1. Number of patients surviving to End of ACLS

    Count of patients surviving to End of Code

    Measured: 1 hour

  2. Number of patients surviving to ICU discharge

    Count of patients surviving to ICU discharge

    Measured: Variable

  3. Number of patients surviving to 30 days

    30 days survival for image guided RescueTEE ACLS versus conventional ACLS

    Measured: 30 days

  4. Neurologically Intact Survival at 3 months

    Neurologically intact survival based on modified Rankin's Score at 3 month

    Measured: 3 months

  5. Neurologically Intact Survival at 6 months

    Neurologically intact survival based on modified Rankin's Score at 6 month

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2020
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Why it stopped: Not enough resources to execute study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Convenience Sampled, Prospective Arm1: Conventional ACLS Arm2: Image Guided RescueTEE ACLS
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04220619
Sponsor's protocol ID
850190
Acronym
ReTEECA
Status last verified
Feb 2024
First submitted
27 Aug 2019
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Gaspari R, Weekes A, Adhikari S, Noble V, Nomura JT, Theodoro D, Woo M, Atkinson P, Blehar D, Brown S, Caffery T, Douglass E, Fraser J, Haines C, Lam S, Lanspa M, Lewis M, Liebmann O, Limkakeng A, Lopez F, Platz E, Mendoza M, Minnigan H, Moore C, Novik J, Rang L, Scruggs W, Raio C. A retrospective study of pulseless electrical activity, bedside ultrasound identifies interventions during resuscitation associated with improved survival to hospital admission. A REASON Study. Resuscitation. 2017 Nov;120:103-107. doi: 10.1016/j.resuscitation.2017.09.008. Epub 2017 Sep 13.

    PubMed 28916478
  • Markin NW, Gmelch BS, Griffee MJ, Holmberg TJ, Morgan DE, Zimmerman JM. A review of 364 perioperative rescue echocardiograms: findings of an anesthesiologist-staffed perioperative echocardiography service. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):82-8. doi: 10.1053/j.jvca.2014.07.004. Epub 2014 Nov 7.

    PubMed 25440641
  • Min JK, Spencer KT, Furlong KT, DeCara JM, Sugeng L, Ward RP, Lang RM. Clinical features of complications from transesophageal echocardiography: a single-center case series of 10,000 consecutive examinations. J Am Soc Echocardiogr. 2005 Sep;18(9):925-9. doi: 10.1016/j.echo.2005.01.034.

    PubMed 16153515
  • Staudt GE, Shelton K. Development of a Rescue Echocardiography Protocol for Noncardiac Surgery Patients. Anesth Analg. 2019 Aug;129(2):e37-e40. doi: 10.1213/ANE.0000000000003569.

    PubMed 29916865
  • Long B, Alerhand S, Maliel K, Koyfman A. Echocardiography in cardiac arrest: An emergency medicine review. Am J Emerg Med. 2018 Mar;36(3):488-493. doi: 10.1016/j.ajem.2017.12.031. Epub 2017 Dec 16.

    PubMed 29269162
  • Gaspari R, Weekes A, Adhikari S, Noble VE, Nomura JT, Theodoro D, Woo M, Atkinson P, Blehar D, Brown SM, Caffery T, Douglass E, Fraser J, Haines C, Lam S, Lanspa M, Lewis M, Liebmann O, Limkakeng A, Lopez F, Platz E, Mendoza M, Minnigan H, Moore C, Novik J, Rang L, Scruggs W, Raio C. Emergency department point-of-care ultrasound in out-of-hospital and in-ED cardiac arrest. Resuscitation. 2016 Dec;109:33-39. doi: 10.1016/j.resuscitation.2016.09.018. Epub 2016 Sep 28.

    PubMed 27693280
  • Arntfield R, Lau V, Landry Y, Priestap F, Ball I. Impact of Critical Care Transesophageal Echocardiography in Medical-Surgical ICU Patients: Characteristics and Results From 274 Consecutive Examinations. J Intensive Care Med. 2020 Sep;35(9):896-902. doi: 10.1177/0885066618797271. Epub 2018 Sep 6.

    PubMed 30189783
  • Daniel WG, Erbel R, Kasper W, Visser CA, Engberding R, Sutherland GR, Grube E, Hanrath P, Maisch B, Dennig K, et al. Safety of transesophageal echocardiography. A multicenter survey of 10,419 examinations. Circulation. 1991 Mar;83(3):817-21. doi: 10.1161/01.cir.83.3.817.

    PubMed 1999032
  • Fair J, Mallin M, Mallemat H, Zimmerman J, Arntfield R, Kessler R, Bailitz J, Blaivas M. Transesophageal Echocardiography: Guidelines for Point-of-Care Applications in Cardiac Arrest Resuscitation. Ann Emerg Med. 2018 Feb;71(2):201-207. doi: 10.1016/j.annemergmed.2017.09.003. Epub 2017 Nov 6.

    PubMed 29107407
  • Shillcutt SK, Markin NW, Montzingo CR, Brakke TR. Use of rapid "rescue" perioperative echocardiography to improve outcomes after hemodynamic instability in noncardiac surgical patients. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):362-70. doi: 10.1053/j.jvca.2011.09.029. Epub 2012 Jan 4.

    PubMed 22226417
  • Teran F, Dean AJ, Centeno C, Panebianco NL, Zeidan AJ, Chan W, Abella BS. Evaluation of out-of-hospital cardiac arrest using transesophageal echocardiography in the emergency department. Resuscitation. 2019 Apr;137:140-147. doi: 10.1016/j.resuscitation.2019.02.013. Epub 2019 Feb 16.

    PubMed 30779977

Questions about this trial

What is this clinical trial studying?

A study testing Tranesophageal Echocardiography in people with Echocardiography, Transesophageal and In-hospital Cardiac Arrest, run by University of Pennsylvania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04220619, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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