Closed–Loop ventilation using sidestream versus mainstream capnography for automated adjustments of minute ventilation—A randomized clinical trial in cardiac surgery patients

PLoS ONE, vol. 18, pp. e0289412

Abstract

BACKGROUND: INTELLiVENT-Adaptive Support Ventilation (ASV) is a closed-loop ventilation mode that uses capnography to adjust tidal volume (VT) and respiratory rate according to a user-set end-tidal CO2 (etCO2) target range. We compared sidestream versus mainstream capnography with this ventilation mode with respect to the quality of breathing in patients after cardiac surgery. METHODS: Single-center, single-blinded, non-inferiority, randomized clinical trial in adult patients scheduled for elective cardiac surgery that were expected to receive at least two hours of postoperative ventilation in the ICU. Patients were randomized 1:1 to closed-loop ventilation with sidestream or mainstream capnography. Each breath was classified into a zone based on the measured VT, maximum airway pressure, etCO2 and pulse oximetry. The primary outcome was the proportion of breaths spent in a predefined 'optimal' zone of ventilation during the first three hours of postoperative ventilation, with a non-inferiority margin for the difference in the proportions set at -20%. Secondary endpoints included the proportion of breaths in predefined 'acceptable' and 'critical' zones of ventilation, and the proportion of breaths with hypoxemia. RESULTS: Of 80 randomized subjects, 78 were included in the intention-to-treat analysis. We could not confirm the non-inferiority of closed-loop ventilation using sidestream with respect to the proportion of breaths in the 'optimal' zone (mean ratio 0.87 [0.77 to ∞]; P = 0.116 for non-inferiority). The proportion of breaths with hypoxemia was higher in the sidestream capnography group versus the mainstream capnography group. CONCLUSIONS: We could not confirm that INTELLiVENT-ASV using sidestream capnography is non-inferior to INTELLiVENT-ASV using mainstream capnography with respect to the quality of breathing in subjects receiving postoperative ventilation after cardiac surgery. TRIAL REGISTRATION: NCT04599491 (clinicaltrials.gov).

Authors 11

1. Sunny G. L. H. Nijbroek corresponding

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Anesthesiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

   Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

2. Jan-Paul Roozeman

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Anesthesiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

   Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

3. Sarah Ettayeby

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

4. Neeltje M. Rosenberg

   Amsterdam UMC Location University of Amsterdam · Spaarne Ziekenhuis · Amsterdam University Medical Centers · Spaarne Gasthuis

   Affiliation as printed

   Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

   Department of Internal Medicine, Spaarne Hospital, Haarlem, The Netherlands

5. David M. P. van Meenen

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Anesthesiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

   Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

6. Thomas G. V. Cherpanath

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

7. Wim K. Lagrand

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

8. Robert Tepaske

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

9. Robert J.M. Klautz Aachen Department of Cardiothoracic Surgery

   Leiden University Medical Center · Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Cardiothoracic Surgery, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

   Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The Netherlands

10. Ary Serpa Neto

    The University of Melbourne · Hospital Israelita Albert Einstein · Austin Hospital · Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Monash University

    Affiliation as printed

    Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

    Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paolo, Brazil

    Department of Critical Care, Austin Hospital, Melbourne Medical School, University of Melbourne, Melbourne, Australia

    Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

    Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

    Australian and New Zealand Intensive Care Research Centre (ANZIC–RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

11. Marcus Josephus Schultz

    Mahidol University · Amsterdam UMC Location University of Amsterdam · University of Oxford · Mahidol Oxford Tropical Medicine Research Unit · Amsterdam University Medical Centers

    Affiliation as printed

    Department of Intensive Care, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

    Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand

    Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom

    Mahidol–Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand