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Conservative vs conventional oxygen administration in critically ill patients: effects on ICU mortality. A multicentre randomized open label clinical trial.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518092-62-00
Acronym
ICUConservativeO2
Enrollment
1000
Registered
2024-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult critically ill patients requiring non-invasive (NIMV) or invasive mechanical ventilation (IMV)

Brief summary

ICU mortality rate, defined as the number of deaths for any cause occurred strictly during the ICU stay (censored at day 90).

Detailed description

- 90-day mortality, - The occurrence of new organ dysfunction defined as a SOFA score ≥3 for the corresponding organ, occurring ≥48 hours after ICU admission, - bloodstream, respiratory and surgical site infections, - VFHs during the ICU stay, - VasoFHs during the ICU stay, - ICU free days at 28-day and at 90-day, - Cognitive Dysfunction at ICU discharge (censored at 90 days) by MMSE, - ICU acquired weakness at ICU discharge (censored at 90 days) by MRC Scale.

Interventions

DRUGOXYGEN

Sponsors

Azienda Ospedaliero Universitaria Di Modena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
ICU mortality rate, defined as the number of deaths for any cause occurred strictly during the ICU stay (censored at day 90).

Secondary

MeasureTime frame
- 90-day mortality, - The occurrence of new organ dysfunction defined as a SOFA score ≥3 for the corresponding organ, occurring ≥48 hours after ICU admission, - bloodstream, respiratory and surgical site infections, - VFHs during the ICU stay, - VasoFHs during the ICU stay, - ICU free days at 28-day and at 90-day, - Cognitive Dysfunction at ICU discharge (censored at 90 days) by MMSE, - ICU acquired weakness at ICU discharge (censored at 90 days) by MRC Scale.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026