CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT04291911
NCT04291911N/ACompleted

Prospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen

SIZ Nursing·observational·Posted Mar 2, 2020·Updated Oct 8, 2020

In Brief

An observational study for Hyperoxia. Completed, enrolled 300 participants across 1 site.

Detailed Summary

Oxygen is the most widely prescribed therapy in the ICU (intensive care unit) and can save lives in critical patients. While the deleterious effects of hypoxia are apparent and must be actively avoided, hyperoxia also has adverse effects. These include systemic, coronary and cerebral vasoconstriction; decreased coronary blood flow; pulmonary atelectasis and increased free radicals. Despite these deleterious effects, hyperoxia is common and frequent in the ICU (from 22% to 74%). A recent meta-analysis published in "The Lancet" with more than 16,000 patients demonstrated an association between liberal oxygen therapy and mortality in critical patients. Other meta-analyses confirm its results with high quality data according to the authors. A randomized controlled trial published in "The New England Journal of Medicine" comparing liberal versus conservative oxygen therapy showed no difference in mechanical ventilation days and mortality (The ICU-ROX, 2019). However, the difference in PaO2 between the two groups was very small and the PaO2 in the liberal group did not exceed 100 mmHg. In any case, conservative oxygen therapy is safe for critical patients. The recommendations therefore recommend an oxygen saturation between 94-97% in critical patients and 88-92% in patients with COPD (Chronic Obstructive Pulmonary Disease) . However, to our knowledge, no study has described the incidence of hyperoxia in non-intubated patients in the intensive care unit.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHyperoxia
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 2, 2020
Enrollment StartSep 21, 2020
Primary CompletionSep 25, 2020
TodayJul 2, 2026
Enrollment to primary: 4 daysPosted 6.3 years ago