RescueTEE for In-hospital Cardiac Arrest (ReTEECA Trial)

NCT04220619 | Withdrawn DMC FDA Device

• 1 other identifier: 850190
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Echocardiography, Transesophageal; In-hospital Cardiac Arrest; Cardiac Arrest; Cardiopulmonary Arrest With Successful Resuscitation; ACLS; Image Guided ACLS

Keywords

Cardiac Arrest; Transesophageal Echocardiography; CPR; Image Guided CPR; Conventional CPR; RescueTEE

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (5)

• Number of patients surviving to End of ACLS

  1 hour

• Number of patients surviving to ICU discharge

  Variable

• Number of patients surviving to 30 days

  30 days

• Neurologically Intact Survival at 3 months

  3 months

• Neurologically Intact Survival at 6 months

  6 months

Other Outcomes (5)

• Optimal Hand Positioning

  1 hour

• Feasibility and safety of TEE probe insertion during CPR

  10 minutes

• Image quality

  1 hour

Study Arms (2)

Conventional ACLS

NO INTERVENTION

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

RescueTEE guided ACLS

EXPERIMENTAL

Patients who have RescueTEE guided ACLS

Diagnostic Test: Tranesophageal Echocardiography

Interventions

Tranesophageal Echocardiography DIAGNOSTIC_TEST

RescueTEE during ACLS versus Conventional ACLS

RescueTEE guided ACLS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Related Publications (11)

• 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.

  PMID: 28916478 BACKGROUND

• 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.

  PMID: 25440641 BACKGROUND

• 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.

  PMID: 16153515 BACKGROUND

• 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.

  PMID: 29916865 BACKGROUND

• 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.

  PMID: 29269162 BACKGROUND

• 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.

  PMID: 27693280 BACKGROUND

• 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.

  PMID: 30189783 BACKGROUND

• 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.

  PMID: 1999032 BACKGROUND

• 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.

  PMID: 29107407 BACKGROUND

• 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.

  PMID: 22226417 BACKGROUND

• 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.

  PMID: 30779977 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Primary Investigator

Model Details: Convenience Sampled, Prospective Arm1: Conventional ACLS Arm2: Image Guided RescueTEE ACLS

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: January 7, 2020
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share