Optiflow in Sequential Non-Invasive Ventilation (NCT02389166) | Clinical Trial Compass
CompletedNot Applicable
Optiflow in Sequential Non-Invasive Ventilation
France95 participantsStarted 2015-06-25
Plain-language summary
Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. In observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory failure. Oxygenation is better than under high-concentration mask and work of breathing is reduced.
The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session), during the first two NIV sessions
Study design : Prospective, randomized, controlled, multicentric, open clinical trial with two groups:
* control group with conventional clinical management, oxygen therapy and sequential used of NIV
* Optiflow group with high flow oxygen delivery system, conventional clinical management and sequential used of NIV for a period of 36 hours at least.
Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for hypoxemic respiratory failure.
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:
* Patient at least 18 years old
* Patients affiliated to or benefiting of the French social welfare system
* Patients with ARDS on previously healthy lung. Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio less than 200 mm Hg associated with the presence of lung infiltrates on chest radiograph
* Free and informed consent of patient
* Hospitalized in one of involved ICU
Exclusion Criteria:
* Existence of criteria for intubation.
* Refusal to participate in the study.
* Pregnancy
* Patient under guardianship or trusteeship
* Patients for whom a decision of non intubation has been decided.
* Patients who have received one or several NIV session for ARDS before hospital admission
* Home noninvasive ventilation
* Tracheostomy
* Hemodynamic instability
* Hypercapnia (PaCO2\>45 mm Hg).
* left ventricular failure (cardiogenic pulmonary acute edema).
* Ineffective coughing.
* Recent gastric or oesophageal surgery
* Severe ventricular rhythm disorder
* High digestive haemorrhage
* Lack of collaboration
* Pernicious vomiting
* Upper airway obstruction
* Severe sepsis.
* Undrained pneumothorax.
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
1
Average of oxygenation differences measured as the delta between PaO2/FiO2ratio at the end of the first ans second NIV session and at the end of the first and second oxygen therapy session.