Study on Oxygen and Nitrous Oxide Use in Critically Ill Adults on Ventilators

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What is this study about?

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.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will need to provide informed consent, which means you agree to participate after understanding the study details.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking if you are a critically ill patient requiring respiratory support, either non-invasive or invasive mechanical ventilation, and if you are expected to stay in the ICU for more than 72 hours.

3 randomization

You will be randomly assigned to one of two groups: the conservative oxygen administration group or the conventional oxygen administration group. This means you will receive either a strict or a more liberal oxygen treatment strategy.

4 treatment phase

During the treatment phase, you will receive oxygen therapy as per the group you are assigned to. The oxygen will be administered orally, and the dosage and frequency will be determined by the medical team based on your condition.

5 monitoring

Your health will be closely monitored throughout your ICU stay. This includes tracking your oxygen levels, organ function, and any new infections or complications. The medical team will use various scales and scores to assess your condition.

6 end of ICU stay

At the end of your ICU stay, your survival will be evaluated. The primary goal is to see if the oxygen treatment strategy has affected your survival rate during the ICU stay.

7 follow-up

After your ICU stay, there will be follow-up assessments to check for any long-term effects, such as cognitive function and muscle strength. These assessments will be conducted up to 90 days after your ICU admission.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino	Turin	Italy
Azienda Ospedaliero-Universitaria Sant’Anna	Ferrara	Italy
Actsgvk Olkcabddamo Utnnnvdhxgqqu Pzkuy	Parma	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	04.11.2019

Trial locations

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.

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 ID:

2024-518092-62-00

Protocol code:

ICUConservativeO2

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Oxygen and Nitrous Oxide Use in Critically Ill Adults on Ventilators

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?