An interventional study of Tranesophageal Echocardiography in Echocardiography, Transesophageal, In-hospital Cardiac Arrest and Cardiac Arrest, sponsored by University of Pennsylvania. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Diagnostic
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.
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:
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.
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Exclusion Criteria:
Patients who have conventional ACLS during in-hospital Cardiac arrest, they will not have RescueTEE
Patients who have RescueTEE guided ACLS
Diagnostic Test: Tranesophageal Echocardiography
RescueTEE during ACLS versus Conventional ACLS
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.
Time frame: 3 months
Number of patients surviving to End of ACLS
Count of patients surviving to End of Code
Time frame: 1 hour
Number of patients surviving to ICU discharge
Count of patients surviving to ICU discharge
Time frame: Variable
Number of patients surviving to 30 days
30 days survival for image guided RescueTEE ACLS versus conventional ACLS
Time frame: 30 days
Neurologically Intact Survival at 3 months
Neurologically intact survival based on modified Rankin's Score at 3 month
Time frame: 3 months
Neurologically Intact Survival at 6 months
Neurologically intact survival based on modified Rankin's Score at 6 month
Time frame: 6 months
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
Time frame: 1 hour
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.
Time frame: 10 minutes
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.
Time frame: 1 hour
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.
Time frame: 1 hour
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.
Time frame: 1 hour
No study locations are listed for this record.
Plan to share: No
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