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Continual hemodynamic monitoring with a single-use transesophageal echocardiography probe in critically ill patients with shock: a randomized controlled clinical trial

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A Correction to this article was published on 22 July 2019

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Abstract

Purpose

Mortality in circulatory shock is high. Enhanced resolution of shock may improve outcomes. We aim to determine whether adding hemodynamic monitoring with continual transesophageal echocardiography (hTEE) to usual care accelerates resolution of hemodynamic instability.

Methods

550 patients with circulatory shock were randomly assigned to four groups stratified using hTEE (hTEE vs usual care) and assessment frequency (minimum every 4 h vs 8 h). Primary outcome was time to resolution of hemodynamic instability, analyzed as intention-to-treat (ITT) analysis at day 6 and in a predefined secondary analysis at days 3 and 28.

Results

Of 550 randomized patients, 271 with hTEE and 274 patients with usual care were eligible and included in the ITT analysis. Time to resolution of hemodynamic instability did not differ within the first 6 days [hTEE vs usual care adjusted sub-hazard ratio (SHR) 1.20, 95% confidence interval (CI) 0.98–1.46, p = 0.067]. Time to resolution of hemodynamic instability during the 72 h of hTEE monitoring was shorter in patients with TEE (hTEE vs usual care SHR 1.26, 95% CI 1.02–1.55, p = 0.034). Assessment frequency had no influence. Time to resolution of clinical signs of hypoperfusion, duration of organ support, length of stay and mortality in the intensive care unit and hospital, and mortality at 28 days did not differ between groups.

Conclusions

In critically ill patients with shock, hTEE monitoring or hemodynamic assessment frequency did not influence resolution of hemodynamic instability or mortality within the first 6 days.

Trial registration and statistical analysis plan

ClinicalTrials.gov Identifier: NCT02048566.

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Change history

  • 22 July 2019

    The original version of this article unfortunately contained a mistake.

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Funding

ImaCor Inc, Garden City, NY, USA, provided 100 hTEE probes free of charge for the study. The funder had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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Authors and Affiliations

  1. Department of Intensive Care Medicine, University Hospital, University of Bern, 3010, Bern, Switzerland

    Tobias M. Merz, Luca Cioccari, Andreas Bloch, David Berger, Bjoern Zante, Stephan M. Jakob & Jukka Takala

  2. Department of General Internal Medicine, University Hospital, University of Bern, Bern, Switzerland

    Pascal M. Frey

Authors
  1. Tobias M. Merz
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  2. Luca Cioccari
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  3. Pascal M. Frey
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  4. Andreas Bloch
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  5. David Berger
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  6. Bjoern Zante
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  7. Stephan M. Jakob
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  8. Jukka Takala
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Corresponding author

Correspondence to Tobias M. Merz.

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Conflicts of interest

Dr Takala has, after his retirement from the Department of Intensive Care Medicine in August 2018, provided paid consultancy services for the Medical Director and the Director of Technology and Innovation of the Inselspital, Bern University Hospital, and to Nestec SA. The Department of Intensive Care Medicine has, or has had in the past, research contracts with Orion Corporation, Abbott Nutrition International, B. Braun Medical AG, CSEM SA, Edwards Lifesciences Services GmbH, Kenta Biotech Ltd, Maquet Critical Care AB, Omnicare Clinical Research AG and research & development/consulting contracts with Edwards Lifesciences SA, Maquet Critical Care AB, and Nestlé. The money was paid into a departmental fund, and nine of the authors received financial gain. The Department of Intensive Care Medicine has received unrestricted educational grants from the following organizations for organizing a quarterly postgraduate educational Symposium, the Berner Forum for Intensive Care (until 2015): Fresenius Kabi, GSK, MSD, Lilly, Baxter, Astellas, AstraZeneca, B | Braun, CSL Behring, Maquet, Novartis, Covidien, Nycomed, Pierre Fabre Pharma AG (formerly known as RobaPharm), Pfizer, Orion Pharma, Bard Medica S.A., Abbott AG, Anandic Medical Systems. The Department of Intensive Care Medicine has received unrestricted educational grants from the following organizations for organizing bi-annual postgraduate courses in the fields of critical care ultrasound, management of ECMO and mechanical ventilation: Pierre Fabre Pharma AG (formerly known as RobaPharm), Pfizer AG, Bard Medica S.A., Abbott AG, Anandic Medical Systems, PanGas AG Healthcare, Orion Pharma, Bracco, Edwards Lifesciences AG, Hamilton Medical AG, Fresenius Kabi (Schweiz) AG, Getinge Group Maquet AG, Dräger Schweiz AG, Teleflex Medical GmbH.

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Merz, T.M., Cioccari, L., Frey, P.M. et al. Continual hemodynamic monitoring with a single-use transesophageal echocardiography probe in critically ill patients with shock: a randomized controlled clinical trial. Intensive Care Med 45, 1093–1102 (2019). https://doi.org/10.1007/s00134-019-05670-6

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