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

Trials

M. J. Schultz¹  E. de Jonge²  D. J. van Westerloo²  L. I. van der Wal³  C. C. A. Grim³  H. J. F. Helmerhorst³  P. Pelosi⁴ 

[1] 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;Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, Leiden, ZA, The Netherlands;Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, Leiden, ZA, The Netherlands;Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333, Leiden, ZA, The Netherlands;Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Largo R. Benzi 10, 16132, Genoa, Italy;Department of Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Largo R. Benzi 10, 16132, Genoa, Italy;

关键词: Mechanical ventilation;    Oxygen inhalation therapy;    Intensive care;    Oxygen;    Clinical trial;   

DOI  :  10.1186/s13063-022-06065-7

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY