ICONIC study—conservative versus conventional oxygenation targets in intensive care patients: study protocol for a randomized clinical trial

Trials, vol. 23, pp. 136

Abstract

Abstract Background Oxygen therapy is a widely used intervention in acutely ill patients in the intensive care unit (ICU). It is established that not only hypoxia, but also prolonged hyperoxia is associated with poor patient-centered outcomes. Nevertheless, a fundamental knowledge gap remains regarding optimal oxygenation for critically ill patients. In this randomized clinical trial, we aim to compare ventilation that uses conservative oxygenation targets with ventilation that uses conventional oxygen targets with respect to mortality in ICU patients. Methods The “ConservatIve versusCONventional oxygenation targets inIntensiveCare patients” trial (ICONIC) is an investigator-initiated, international, multicenter, randomized clinical two-arm trial in ventilated adult ICU patients. The ICONIC trial will run in multiple ICUs in The Netherlands and Italy to enroll 1512 ventilated patients. ICU patients with an expected mechanical ventilation time of more than 24 h are randomized to a ventilation strategy that uses conservative (PaO255–80 mmHg (7.3–10.7 kPa)) or conventional (PaO2110–150 mmHg (14.7–20 kPa)) oxygenation targets. The primary endpoint is 28-day mortality. Secondary endpoints are ventilator-free days at day 28, ICU mortality, in-hospital mortality, 90-day mortality, ICU- and hospital length of stay, ischemic events, quality of life, and patient opinion of research and consent in the emergency setting. Discussion The ICONIC trial is expected to provide evidence on the effects of conservative versus conventional oxygenation targets in the ICU population. This study may guide targeted oxygen therapy in the future. Trial registration Trialregister.nl NTR7376 . Registered on 20 July, 2018.

Authors 34

1. Chloe C.A. Grim Aachen Department of Anesthesiology, Leiden University Medical Center Department of Intensive Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

   Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

2. Lea Imeen van der Wal corresponding Aachen Department of Anesthesiology, Leiden University Medical Center Department of Intensive Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands. L.I.van_der_wal@lumc.nl

   Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands. L.I.van_der_wal@lumc.nl

   Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

3. Hendrik J. F. Helmerhorst Aachen Department of Anesthesiology, Leiden University Medical Center Department of Intensive Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

   Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

4. David J. van Westerloo Aachen Department of Intensive Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

5. Paolo P. Pelosi

   Ospedale Policlinico San Martino

   Affiliation as printed

   Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Largo R. Benzi 10, 16132, Genoa, Italy

   Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Largo R. Benzi 10, 16132, Genoa, Italy

6. 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 Centre, Location AMC, Amsterdam, The Netherlands

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

   Nuffield Department of medicine, University of Oxford, Oxford, UK

7. Evert de Jonge Aachen Department of Intensive Care

   Leiden University Medical Center

   Affiliation as printed

   Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

8. Jeanette Wigbers

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

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

9. Marnix J. Sigtermans

   Mahidol University · Mahidol Oxford Tropical Medicine Research Unit

   Affiliation as printed

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

10. Lilian Dawson
11. P. L. J. van der Heijden
12. E. Y. Schriel-van den Berg
13. Bert G. Loef

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

14. A. C. Reidinga

    Ospedale Policlinico San Martino

    Affiliation as printed

    Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Largo R. Benzi 10, 16132, Genoa, Italy

15. Els de Vreede

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

16. Jolanda Qualm
17. E. Christiaan Boerma

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

18. Hilda Rijnhart-de Jong

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

19. Matty Koopmans Aachen Department of Anesthesiology, Leiden University Medical Center

    Leiden University Medical Center

    Affiliation as printed

    Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

20. Alexander Daniel Cornet

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

21. M. Rinket
22. Wytze Vermeijden
23. Albertus Beishuizen
24. F. Jeannette Schoonderbeek

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

25. Judith van Holten

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

26. Anissa M. Tsonas

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

27. Michela Botta

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

28. Tineke Winters

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

29. Janneke Horn Aachen Department of Anesthesiology, Leiden University Medical Center

    Leiden University Medical Center

    Affiliation as printed

    Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

30. Frederique Paulus

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

31. Maurizio Loconte Aachen Department of Anesthesiology, Leiden University Medical Center

    Leiden University Medical Center

    Affiliation as printed

    Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands

32. Denise Battaglini

    University of Oxford

    Affiliation as printed

    Nuffield Department of medicine, University of Oxford, Oxford, UK

33. Lorenzo Ball

    Ospedale Policlinico San Martino

    Affiliation as printed

    Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Largo R. Benzi 10, 16132, Genoa, Italy

34. Iole Brunetti