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BackgroundOxygen 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.MethodsThe "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.DiscussionThe 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 registrationTrialregister.nl NTR7376 . Registered on 20 July, 2018.

Original publication

DOI

10.1186/s13063-022-06065-7

Type

Journal article

Journal

Trials

Publication Date

13/02/2022

Volume

23

Addresses

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

Keywords

ICONIC Investigators and PROVE Network, Humans, Respiration, Artificial, Critical Care, Oxygen Inhalation Therapy, Quality of Life, Adult, Intensive Care Units, Multicenter Studies as Topic, Randomized Controlled Trials as Topic