Cardiac Arrest Clinical Trial
— ReTEECAOfficial title:
Rescue Transesophageal Echocardiography for the Guidance of Cardiopulmonary Resuscitation for In-hospital Cardiac Arrest Versus Conventional ACLS
NCT number | NCT04220619 |
Other study ID # | 850190 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2024 |
Est. completion date | December 1, 2024 |
Verified date | February 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Pennsylvania |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Optimal Hand Positioning | Comparing baseline hand positioning versus RescueTEE guided hand positioning during cardiac arrest.
The echocardiographer will use RescueTEE to optimize hand positioning during cardiac arrest. This information will be documented before and after changing hand positioning to determine if there was a resultant change in ROSC. We will assess if optimization of hand positioning over the area of maximal impulse (AMI) during chest compressions based on TEE results in increased likelihood of ROSC |
1 hour | |
Other | Feasibility and safety of TEE probe insertion during CPR | To calculate the failure rates, feasibility, and technical issues in placing TEE probes during ACLS. This will be determined by asking code leaders to fill up a follow up form to reflect a qualitative feedback to see if TEE was useful in a subjective manner. We will also calculate the time from code to TEE probe insertion and also the time for total examination. Data will be collected on the technical challenges encountered with probe placement. Post-event images will be reviewed and quality will be assessed in terms of clarity, motion artifact, and reproducibility. | 10 minutes | |
Other | Image quality | To document the imaging quality and diagnostic capabilities of RescueTEE during ACLS. A blinded reviewer will perform QI on the image quality. This will be a descriptive statistic looking at contrast, gain both lateral and medial gain, overgain, image depth, focus length. Numerical outcomes of which views were obtained from the 5 selected views. These will be reported as standard echocardiography image quality assessments are done for clinical practice. | 1 hour | |
Other | Diagnoses of pathology in image guided ACLS | Descriptive statistics: To document the range of diagnoses RescueTEE can provide during CPR in the management of in-hospital arrest or critical hemodynamic instability. The RescueTEE form competed by the echocardiographer lists several diagnoses including the following: cardiac tamponade, LV thrombus, RV thrombus, fine VF, Pulseless rhythm with echocardiographic evidence of motion (PREM) versus Pulseless rhythm with echocardiographic evidence of standstill (PRES), myocardial infarction, aortic dissection, severe hypovolemia, severe global LV dysfunction, severe global RV dysfunction, and LV free wall rupture. | 1 hour | |
Other | Interventional and therapeutic support during image guided ACLS | Descriptive statistics: To document and classify the role that RescueTEE can provide which leads to therapeutic guidance or intervention for the code leader during arrest situations. Information regarding the interventions will include TEE driven medication administration or procedural management. This will also be recorded as a categorical variable as; fluid given, blood given, epinephrine given, shock advised for pulseless rhythm with echocardiographic evidence of motion (PREM), calcium given, pericardiocentesis performed, ECMO cannulation completed, thrombolytics administered, or chest compressions hand positioning changed, or chest compressions terminated. | 1 hour | |
Primary | 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 | Number of patients surviving to End of ACLS | Count of patients surviving to End of Code | 1 hour | |
Secondary | Number of patients surviving to ICU discharge | Count of patients surviving to ICU discharge | Variable | |
Secondary | Number of patients surviving to 30 days | 30 days survival for image guided RescueTEE ACLS versus conventional ACLS | 30 days | |
Secondary | Neurologically Intact Survival at 3 months | Neurologically intact survival based on modified Rankin's Score at 3 month | 3 months | |
Secondary | Neurologically Intact Survival at 6 months | Neurologically intact survival based on modified Rankin's Score at 6 month | 6 months |
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