Study Comparing Non-Invasive Ventilation and High Flow Oxygen Therapy for Patients at Risk of Breathing Support Failure After Ventilator Removal

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What is this study about?

This clinical trial is focused on patients who are at high risk of experiencing difficulties after being taken off a breathing machine, a process known as extubation. The study is comparing two different methods to help these patients breathe more easily: Non-Invasive Ventilation and High Flow Oxygenotherapy. Non-Invasive Ventilation involves using a mask to support breathing without the need for a tube, while High Flow Oxygenotherapy delivers a high flow of oxygen through a nasal cannula, which is a small tube placed in the nostrils.

The main goal of the study is to reduce the chances of extubation failure, which means preventing the need to put the patient back on a breathing machine. The study will observe patients for signs of breathing problems within 48 hours after extubation. It will also look at other outcomes such as the need for re-intubation, infections acquired in the hospital, the need for a surgical opening in the windpipe (tracheotomy), organ failure, and mortality rates both in the intensive care unit (ICU) and the hospital. Additionally, the study will track how long patients stay in the ICU and the hospital, as well as the duration of mechanical ventilation.

The treatment being tested in this study is Oxígeno Medicinal Líquido Air Liquide 99.5% v/v, which is a form of medicinal oxygen used in the High Flow Oxygenotherapy method. This oxygen is delivered as a cryogenic gas, meaning it is stored at very low temperatures in fixed containers and is inhaled by the patient. The study aims to provide valuable information on which method is more effective in supporting patients who are at risk of extubation failure, ultimately improving their recovery process.

1 joining the study

Upon joining the study, the patient will be assessed to ensure they meet the inclusion criteria. These criteria include being 65 years or older, having certain medical conditions such as chronic obstructive pulmonary disease (COPD) or asthma, and having been on mechanical ventilation for more than 7 days.

2 initial assessment

An initial assessment will be conducted to evaluate the patient’s current health status. This includes checking for hypercapnia, which is a condition where there is too much carbon dioxide in the blood, and assessing the effectiveness of the patient’s cough and the presence of secretions.

3 treatment allocation

The patient will be randomly assigned to one of two treatment groups: non-invasive ventilation or high flow oxygen therapy. Both treatments aim to support breathing after extubation, which is the removal of a breathing tube.

4 treatment administration

If assigned to the high flow oxygen therapy group, the patient will receive oxygen through inhalation. The oxygen used is a medicinal gas with a concentration of 99.5% and is administered as a cryogenic gas, which means it is stored at very low temperatures.

5 monitoring and follow-up

The patient’s condition will be closely monitored for signs of acute respiratory failure within 48 hours after extubation. Other aspects such as the need for re-intubation, infections, and overall recovery will also be observed.

6 completion of the study

The study will continue until the estimated end date in September 2027. Throughout the study, data will be collected on various outcomes, including the length of stay in the intensive care unit (ICU) and hospital, as well as overall mortality rates.

Who Can Join the Study?

Must be 65 years or older.
Have hypercapnia, which means having a high level of carbon dioxide in the blood, specifically paCO2 > 45 mmHg at the time of removing the breathing tube.
Have an ineffective cough, meaning the cough is not strong enough to clear the airways.
Have abundant secretions, which means producing a lot of mucus or phlegm.
Have a body mass index (BMI) greater than 30, which indicates obesity.
Have chronic obstructive pulmonary disease (COPD) or asthma as the reason for needing a breathing machine.
Have cardiac failure as the reason for needing a breathing tube or a history of the heart’s ejection fraction being 30% or less.
Have an Acute Physiology and Chronic Health Evaluation (APACHE II) score greater than 12 at the time of removing the breathing tube. This is a score that helps measure the severity of illness.
Have been on a breathing machine for more than 7 days.
Have a positive water balance, meaning the body is retaining more fluid than it is losing.
Experience difficult or prolonged weaning, which means having trouble coming off the breathing machine.
Have pneumonia or any other medical condition, rather than a surgical reason, as the cause of acute respiratory failure (ARF).

Who Cannot Join the Study?

Patients who are not currently on a mechanical ventilator. A mechanical ventilator is a machine that helps you breathe when you cannot do so on your own.
Patients who have already been successfully extubated. Extubation is the process of removing a tube that was helping you breathe.
Patients who are not within the specified age range for the study.
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

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Hospital De Sagunto	Sagunto	Spain
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Hospital General Universitario De Castellon	Castello De La Plana	Spain
Hdvifrvs dt Tkwjzyr Vbsuj du lg Clclb	Tortosa	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Oxygen

Non-Invasive Ventilation (NIV) is a therapy that helps patients breathe without the need for a tube inserted into the windpipe. It uses a mask or similar device to provide air or oxygen to the lungs, supporting breathing and reducing the effort needed by the patient. This therapy is often used for patients who are at risk of breathing difficulties after being taken off a ventilator.

High Flow Oxygen Therapy is a treatment that delivers a high flow of oxygen through a nasal cannula. This therapy provides a higher concentration of oxygen than standard oxygen therapy and helps keep the airways open, making it easier for patients to breathe. It is used to support patients who may have trouble breathing on their own after being extubated.

Investigated diseases:

Weaning failure

Acute Respiratory Failure – This condition occurs when the lungs cannot provide enough oxygen to the blood or remove carbon dioxide from the blood. It can develop quickly and may be caused by various factors, including lung diseases, injuries, or infections. Symptoms often include difficulty breathing, rapid breathing, and confusion. The condition can lead to a buildup of carbon dioxide in the body, causing further complications. It requires immediate medical attention to prevent severe outcomes. The progression can vary depending on the underlying cause and the individual’s overall health.

Trial ID:

2024-514640-81-00

Protocol code:

REIOT/0624

Trial Phase:

Therapeutic confirmatory (Phase III)

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