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

Phase 3

Not yet recruiting

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

• Registration Number: 2024-518092-62-00
• Lead Sponsor: Azienda Ospedaliero Universitaria Di Modena

Brief Summary

To verify the hypothesis that strict maintenance of normoxia improves survival in a wide population of mechanically ventilated critically ill patients compared to the application of

conventional more liberal strategies of oxygen administration. Survival will be measured at ICU discharge.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-12-09
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

• Critically ill patients admitted to participant ICUs, - Age ≥ 18 years without regards about sex and ethnicity; - Expected length of ICU stay of more than 72 hours. - Need of any respiratory support (IMV or NIMV) at admission and with an expected length of respiratory support ≥ 6 hours - Acquisition of informed consent.

Exclusion Criteria

• Pregnancy: Patients who are known to be pregnant or with a positive serum pregnancy test will be excluded. All potentially fertile females will be tested for pregnancy before enrolment in the study. We will consider as potentially fertile all female patients between 18 and 55 with no documented evidence of menopause, hysterectomy, surgical sterilization. - Admission to ICU after elective surgery - ICU readmission (after a first discharge) in the study period; - IMV or NIMV greater than 12 hours in the 28 days before study inclusion; - Clinical decision to withhold life-sustaining treatment or “too sick to benefit” or patients with a life expectancy of less than 28 days due to a chronic or underlying medical condition. - Previous enrolment in other interventional studies of targeted oxygen therapy; - Acute respiratory failure on chronic obstructive pulmonary disease - Acute respiratory distress syndrome (ARDS) with a PaO2/FiO2 ratio < 150. - Long-term supplemental oxygen therapy. - Patients candidate to hyperoxia treatment for reasons including (but not limited to) carbon monoxide poisoning or to hyperbaric oxygen therapy;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
- 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.		- 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.

Trial Locations

Locations (12)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

Humanitas Mirasole S.p.A.; 🇮🇹 Milan, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Azienda Ospedaliero Universitaria Parma; 🇮🇹 Parma, Italy

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania; 🇮🇹 Catania, Italy

Azienda Sanitaria Universitaria Friuli Centrale; 🇮🇹 Udine, Italy

Azienda Ospedaliero-Universitaria Sant'Anna; 🇮🇹 Ferrara, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone; 🇮🇹 Palermo, Italy

Careggi University Hospital; 🇮🇹 Florence, Italy

A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette; 🇮🇹 Torino, Italy

Scroll for more (2 remaining)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

🇮🇹Rome, Italy

Massimo Antonelli

Site contact

00390630154490

massimo.antonelli@policlinicogemelli.it