Authorised Therapeutic confirmatory (Phase III) Adult critically ill patients requiring non-invasive (NIMV) or invasive mechanical ventilation (IMV)

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

EU CTIS ID: 2024-518092-62-00

What this study is testing

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.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - 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.

You likely can't join if

  • - 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;

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.