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Search / Trial NCT04468126

Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure

Launched by POITIERS UNIVERSITY HOSPITAL · Jul 8, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Acute Hypoxemic Respiratory Failure De Novo Respiratory Failure High Flow Nasal Oxygen Standard Oxygen

ClinConnect Summary

This clinical trial is studying the effectiveness of two types of oxygen therapy for patients experiencing acute hypoxemic respiratory failure, which is when the body doesn’t get enough oxygen due to problems in the lungs. The trial compares standard oxygen therapy with high-flow nasal cannula oxygen therapy to see which one is better at reducing the risk of death. Participants are needed who are adults over 18 years old and have a rapid breathing rate, specific lung issues, and low oxygen levels in their blood.

If someone qualifies and decides to participate, they will receive one of the two oxygen treatments and be monitored for their health outcomes. It's important to know that certain patients, like those needing immediate intubation (a procedure to help with breathing) or those with severe chronic lung diseases, are not eligible for this study. This trial aims to provide clearer evidence to help doctors choose the best oxygen therapy for patients in critical situations.

Gender

ALL

Eligibility 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.

About Poitiers University Hospital

Poitiers University Hospital is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and trials. As a prominent sponsor of clinical studies, the hospital leverages its multidisciplinary expertise and state-of-the-art facilities to explore new therapeutic interventions and improve patient outcomes. With a commitment to ethical standards and patient safety, Poitiers University Hospital collaborates with healthcare professionals, researchers, and institutions to facilitate groundbreaking studies that contribute to medical knowledge and enhance treatment protocols across various specialties.

Locations

Poitiers, , France

Patients applied

0 patients applied

Trial Officials

Jean-Pierre FRAT, PhD

Principal Investigator

CHU Poitiers

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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