Department of Intensive Care, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.
Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.
Trials. 2022 Feb 13;23(1):136. doi: 10.1186/s13063-022-06065-7.
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.
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 55-80 mmHg (7.3-10.7 kPa)) or conventional (PaO 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.
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.
Trialregister.nl NTR7376 . Registered on 20 July, 2018.
氧气疗法是重症监护病房（ICU）中急性病患者广泛使用的干预措施。现已确定，不仅是缺氧，而且长时间的高氧血症也与不良的以患者为中心的结局有关。然而，关于危重病患者的最佳氧合作用，仍存在基本的知识空白。在这项随机临床试验中，我们旨在比较使用保守氧合目标的通气与使用常规氧合目标的通气在 ICU 患者死亡率方面的差异。
“重症监护患者保守与常规氧合目标”试验（ICONIC）是一项由研究者发起的、国际性的、多中心的、随机的、两臂临床试验，纳入了接受机械通气的成年 ICU 患者。ICONIC 试验将在荷兰和意大利的多个 ICU 中进行，以纳入 1512 名接受机械通气的患者。预计机械通气时间超过 24 小时的 ICU 患者被随机分配到使用保守（PaO 55-80mmHg（7.3-10.7kPa））或常规（PaO 110-150mmHg（14.7-20kPa））氧合目标的通气策略。主要终点是 28 天死亡率。次要终点是 28 天无呼吸机天数、ICU 死亡率、住院死亡率、90 天死亡率、ICU 和住院时间、缺血性事件、生活质量以及患者对紧急情况下研究和同意的看法。
ICONIC 试验有望提供关于 ICU 人群中保守与常规氧合目标的效果证据。这项研究可能为未来的靶向氧疗提供指导。
Trialregister.nl NTR7376。注册于 2018 年 7 月 20 日。
