학술논문
ICONIC study--conservative versus conventional oxygenation targets in intensive care patients: study protocol for a randomized clinical trial
Document Type
Report
Author
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. Schriel-van; 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.
Source
Trials. February 13, 2022, Vol. 23 Issue 1
Subject
Language
English
ISSN
1745-6215
Abstract
Author(s): C. C. A. Grim[sup.1,2] , L. I. van der Wal[sup.1,2] , H. J. F. Helmerhorst[sup.1,2] , D. J. van Westerloo[sup.1] , P. Pelosi[sup.3,4] , M. J. Schultz[sup.5,6,7] , E. [...]
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 (PaO.sub.2 55-80 mmHg (7.3-10.7 kPa)) or conventional (PaO.sub.2 110-150 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. Keywords: Mechanical ventilation, Oxygen inhalation therapy, Intensive care, Oxygen, Clinical trial
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 (PaO.sub.2 55-80 mmHg (7.3-10.7 kPa)) or conventional (PaO.sub.2 110-150 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. Keywords: Mechanical ventilation, Oxygen inhalation therapy, Intensive care, Oxygen, Clinical trial