Comparing standard oxygen to high-flow nasal oxygen therapy for patients with acute hypoxemic respiratory failure
Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.
This study tests whether high-flow nasal oxygen therapy works better than standard oxygen for adults with severe breathing problems caused by low oxygen levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT04468126 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of standard oxygen therapy versus high-flow nasal oxygen therapy in patients suffering from acute hypoxemic respiratory failure. It will enroll patients over 18 years old who exhibit specific clinical criteria, such as a high respiratory rate and low oxygen levels. The primary focus is to evaluate mortality rates between the two oxygen delivery methods, addressing a gap in evidence regarding their comparative effectiveness in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old experiencing acute hypoxemic respiratory failure with specific clinical indicators.
Not a fit: Patients requiring immediate intubation or those with severe chronic lung diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective oxygen therapy for patients with acute hypoxemic respiratory failure, potentially improving survival rates.
How similar studies have performed: Previous studies have indicated that high-flow nasal oxygen may be superior to standard oxygen in certain contexts, but this specific comparison in a broader patient population is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria: * Respiratory rate \>25 breaths/min whatever the oxygen support * Pulmonary infiltrate, * PaO2/FiO2 ≤200 mmHg * Informed consent from the patient or relatives. Exclusion Criteria: * PaCO2 \> 45 mm Hg * Need for emergent intubation: pulse oximetry \< 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points * Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors \> 0.3 µg/kg/min * Glasgow coma scale equal to or below 12 points * Exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of Gold classification), or another chronic lung disease with long term oxygen or ventilatory support * Cardiogenic pulmonary edema as main reason for acute respiratory failure * Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID study has been completed) * Post-extubation respiratory failure within 7 days after extubation, * Post-operative patients within 7 days after abdominal or cardiothoracic surgery, * Do not intubate order; * Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome. * Patients without any healthcare insurance scheme or not benefiting from it through a third party, * Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.
Where this trial is running
Poitiers
- CHu Poitiers — Poitiers, France (Recruiting)
Study contacts
- Principal investigator: Jean-Pierre FRAT, PhD — CHU Poitiers
- Study coordinator: Jean-Pierre FRAT, PhD
- Email: jean-pierre.frat@chu-poitiers.fr
- Phone: 05 49 44 60 64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.