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

Phase 1

• Conditions: adult critically ill patients requiring non-invasive (NIMV) or invasive mechanical ventilation (IMV); MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-002525-35-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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