Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Recruiting
Study on Oxygen and Nitrous Oxide Use in Critically Ill Adults on Ventilators
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of different oxygen administration methods in patients who are critically ill and require mechanical help to breathe. These patients are often in an Intensive Care Unit (ICU) and need either non-invasive or invasive mechanical ventilation. The study will compare two approaches: a conservative method of giving oxygen and a conventional, more liberal method. The main goal is to see if maintaining a normal level of oxygen in the blood, known as normoxia, can improve survival rates for these patients during their stay in the ICU.
The treatment being studied involves the use of a combination of gases, specifically nitrous oxide and oxygen. These gases are administered to help support the patients' breathing. The study will observe the effects of these gases on the patients' health and survival, particularly focusing on the number of deaths that occur during the ICU stay. The study will also look at other health outcomes, such as the development of new organ problems, infections, and the patients' ability to function independently after leaving the ICU.
Participants in this study will be monitored throughout their ICU stay, and their health will be assessed at various points, including at the time of discharge from the ICU. The study aims to provide valuable information on the best way to administer oxygen to critically ill patients to improve their chances of recovery and survival.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Must be a critically ill patient admitted to a participating Intensive Care Unit (ICU).
- Must be 18 years or older, regardless of sex and ethnicity.
- Must have an expected ICU stay of more than 72 hours.
- Must need respiratory support (either non-invasive or invasive mechanical ventilation) at admission, with an expected need for this support for 6 hours or more.
- Must provide informed consent, which means agreeing to participate in the study after understanding all the details.
Who cannot join the trial?
3 criteria
- Patients who are not critically ill and do not require help with breathing through machines.
- Patients who are not adults.
- Patients who are part of a vulnerable population, which means they might need special protection or care.
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Verified Responsive Azienda Ospedaliero Universitaria Careggi
Florence, ItalyResponsive Azienda Ospedaliero Universitaria Parma
Parma, Italy
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Investigated drugs
Oxygen Therapy is a treatment that provides extra oxygen to patients who are unable to get enough oxygen on their own. In this trial, oxygen therapy is used to maintain a normal level of oxygen in the blood of critically ill patients who are on mechanical ventilation. The goal is to see if keeping oxygen levels strictly normal can improve survival rates compared to more relaxed oxygen administration strategies.
What is already known about the treatment
Oxygen Therapy – Oxygen therapy is administered through a mask or nasal tubes to help critically ill patients who need assistance with breathing, either through non-invasive or invasive mechanical ventilation. In medical literature, oxygen therapy is a well-established treatment for patients with respiratory failure or other conditions that impair breathing. The main therapeutic indication for oxygen therapy in this trial is to maintain normal oxygen levels in critically ill patients to improve their chances of survival. At the molecular level, oxygen therapy works by increasing the amount of oxygen available in the blood, which is essential for the body's cells to function properly. It is classified pharmacologically as a respiratory therapy.
Investigated diseases
Critical Illness Requiring Mechanical Ventilation – This condition involves patients who are critically ill and need assistance with breathing through mechanical ventilation. Mechanical ventilation can be either non-invasive, using a mask, or invasive, involving a tube inserted into the airway. The progression of this condition often involves the need for continuous monitoring and support in an intensive care unit (ICU). Patients may experience complications such as infections, organ dysfunction, or muscle weakness due to prolonged immobility. The condition can lead to cognitive dysfunction and ICU-acquired weakness, which are assessed at the time of ICU discharge. The severity and progression depend on the underlying cause of the critical illness and the patient's response to treatment.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518092-62-00Protocol codeICUConservativeO2Estimated enrolment1 000 patientsSponsorAzienda Ospedaliero Universitaria Di Modena
sourced from the EU Clinical Trials Register and site verification
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