ICONIC study—conservative versus conventional oxygenation targets in intensive care patients: study protocol for a randomized clinical trial
Issued Date
2022-12-01
Resource Type
eISSN
17456215
Scopus ID
2-s2.0-85124636687
Pubmed ID
35152909
Journal Title
Trials
Volume
23
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Trials Vol.23 No.1 (2022)
Suggested Citation
Grim C.C.A., van der Wal L.I., Helmerhorst H.J.F., van Westerloo D.J., Pelosi P., Schultz M.J., de Jonge E., del Prado M.R., Wigbers J., Sigtermans M.J., Dawson L., van der Heijden P.L.J., den Berg E.Y.S.v., Loef B.G., Reidinga A.C., de Vreede E., Qualm J., Boerma E.C., Rijnhart-de Jong H., Koopmans M., Cornet A.D., Krol T., Rinket M., Vermeijden J.W., Beishuizen A., Schoonderbeek F.J., van Holten J., Tsonas A.M., Botta M., Winters T., Horn J., Paulus F., Loconte M., Battaglini D., Ball L., Brunetti I. ICONIC study—conservative versus conventional oxygenation targets in intensive care patients: study protocol for a randomized clinical trial. Trials Vol.23 No.1 (2022). doi:10.1186/s13063-022-06065-7 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/85347
Title
ICONIC study—conservative versus conventional oxygenation targets in intensive care patients: study protocol for a randomized clinical trial
Author(s)
Grim C.C.A.
van der Wal L.I.
Helmerhorst H.J.F.
van Westerloo D.J.
Pelosi P.
Schultz M.J.
de Jonge E.
del Prado M.R.
Wigbers J.
Sigtermans M.J.
Dawson L.
van der Heijden P.L.J.
den Berg E.Y.S.v.
Loef B.G.
Reidinga A.C.
de Vreede E.
Qualm J.
Boerma E.C.
Rijnhart-de Jong H.
Koopmans M.
Cornet A.D.
Krol T.
Rinket M.
Vermeijden J.W.
Beishuizen A.
Schoonderbeek F.J.
van Holten J.
Tsonas A.M.
Botta M.
Winters T.
Horn J.
Paulus F.
Loconte M.
Battaglini D.
Ball L.
Brunetti I.
van der Wal L.I.
Helmerhorst H.J.F.
van Westerloo D.J.
Pelosi P.
Schultz M.J.
de Jonge E.
del Prado M.R.
Wigbers J.
Sigtermans M.J.
Dawson L.
van der Heijden P.L.J.
den Berg E.Y.S.v.
Loef B.G.
Reidinga A.C.
de Vreede E.
Qualm J.
Boerma E.C.
Rijnhart-de Jong H.
Koopmans M.
Cornet A.D.
Krol T.
Rinket M.
Vermeijden J.W.
Beishuizen A.
Schoonderbeek F.J.
van Holten J.
Tsonas A.M.
Botta M.
Winters T.
Horn J.
Paulus F.
Loconte M.
Battaglini D.
Ball L.
Brunetti I.
Other Contributor(s)
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 versus CONventional oxygenation targets in Intensive Care 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 (PaO2 55–80 mmHg (7.3–10.7 kPa)) or conventional (PaO2 110–150 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.