UnknownPhase 4

Conservative Versus Conventional Oxygen Administration in Critically Ill Patients

Italy1,000 participantsStarted 2019-12-04

Plain-language summary

Oxygen supplementation in the inspired mixture is commonly used in critically ill patients and observational studies highlight that those patients remain hyperoxemic for substantial periods during Intensive Care Unit stay. However, exposure to inhaled oxygen-enriched mixtures is widely recognized as potentially harmful and cause of organ damage. Although, the specific level of arterial oxygen partial pressure (PaO2) considered harmful, or the dangerous duration of hyperoxia, is not determined yet as there are no clinical trials on humans that evaluate the appropriate percentage of oxygen considered safe to maintain an adequate tissue oxygen availability. The study is designed as a multicentre, open-label, two parallel groups, randomized superiority clinical trial. The study will involve 10 European intensive care units and will recruit adult critically ill patients requiring mechanical ventilation with an expected length of stay of more than 72 hours admitted to the Intensive Care Unit. Within the conventional group, participants will receive an inspired oxygen fraction (FiO2) aiming to maintain an oxygen saturation by pulse oximetry (SpO2) equal or major than 98 percentage, accepting an upper limit of PaO2 of 150 mmHg and a lower limit of 60 mmHg. Patients in the conservative group will receive the lowest FiO2 to maintain SpO2 between 94 and 98 percentage, or when available a PaO2 between 60 mmHg and 100 mmHg. The primary objective of this study is 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 Intensive Care Unit discharge. The confirmation of the efficacy of a conservative strategy for oxygen administration in reducing the mortality rate among critically ill patients will lead to a profound revision of the current clinical practice and a rationale revision of the current recommendations would be mandatory, maybe also in other clinical scenarios such as emergency departments.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Critically ill patients admitted to participant Intensive Care Units * Age major than 18 years without regards about sex and ethnicity * Expected length of Intensive Care Unit stay of more than 72 hours * Need of any respiratory support (invasive or non invasive mechanical ventilation) at admission and with an expected length of respiratory support major than 6 hours * Acquisition of informed consent Exclusion Criteria: * Pregnancy * Admission to Intensive Care Unit after elective surgery * Intensive Care Unit readmission (after a first discharge) in the study period * Invasive or non invasive mechanical ventilation 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 with a PaO2/FiO2 ratio less than 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mortality

Timeframe: Intensive Care Unit discharge censored at day 90

Trial details

NCT IDNCT04198077

SponsorUniversity of Modena and Reggio Emilia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-04

Contact for this trial

Massimo Girardis

0594224934 girardis.massimo@unimore.it

View on ClinicalTrials.gov More Critical Illness trials