NITROUS OXIDE, OXYGEN for Critical illness requiring mechanical ventilation

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- 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.\n- Admission to ICU after elective surgery\n- ICU readmission (after a first discharge) in the study period;\n- IMV or NIMV greater than 12 hours in the 28 days before study inclusion;\n- 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.\n- Previous enrolment in other interventional studies of targeted oxygen therapy;\n- Acute respiratory failure on chronic obstructive pulmonary disease\n- Acute respiratory distress syndrome (ARDS) with a PaO2/FiO2 ratio < 150.\n- Long-term supplemental oxygen therapy.\n- Patients candidate to hyperoxia treatment for reasons including (but not limited to) carbon monoxide poisoning or to hyperbaric oxygen therapy;"}

Primary endpoints

• {"endpoint_text":"- ICU mortality rate, defined as the number of deaths for any cause occurred strictly during the ICU stay (censored at day 90).","definition_or_measurement_approach":"Defined as the number of deaths for any cause occurring strictly during the ICU stay; events censored at day 90."}

Secondary endpoints

• {"endpoint_text":"- 90-day mortality\n- The occurrence of new organ dysfunction defined as a SOFA score ≥3 for the corresponding organ, occurring ≥48 hours after ICU admission\n- bloodstream, respiratory and surgical site infections\n- VFHs during the ICU stay\n- VasoFHs during the ICU stay\n- ICU free days at 28-day and at 90-day\n- Cognitive Dysfunction at ICU discharge (censored at 90 days) by MMSE\n- ICU acquired weakness at ICU discharge (censored at 90 days) by MRC Scale.","definition_or_measurement_approach":"90-day mortality: death by day 90. New organ dysfunction: defined as SOFA score ≥3 for the corresponding organ occurring ≥48 hours after ICU admission. Infections: bloodstream, respiratory and surgical site infections (microbiologically documented as described in secondary objectives). Cognitive dysfunction measured by MMSE at ICU discharge (censored at 90 days). ICU acquired weakness measured by MRC Scale at ICU discharge (censored at 90 days). ICU free days: number of days alive and free from ICU up to day 28 and day 90. VFHs and VasoFHs: as listed in protocol (term quoted verbatim)."}

Italy

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

20-01-2026

Processing Time Days

455

Number Of Sites

12

Number Of Participants

1000

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Di Modena

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy