Optimising high-flow oxygen settings in hypoxemic distress using depth-camera lung-volume measurements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3 interventional trial, adults with hypoxemic respiratory distress in the ICU are randomized to receive high-flow oxygen either by standard practice or with ventilatory parameters adjusted according to lung volumes measured non-invasively by a depth-camera system. The depth camera tracks chest and abdominal movements to estimate lung volume, respiratory rate, and symmetry, guiding oxygen flow. The goal is to see if this measurement-guided approach lowers the intubation rate and improves oxygenation compared with conventional care. The study uses a non-contact method to obtain physiological data, integrating it into the HFO management algorithm. Primary outcomes focus on need for intubation; secondary outcomes may include oxygenation metrics and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with hypoxemic respiratory distress define by the following 4 criteria:
* Respiratory rate ≥ 25 breaths per minutes
* A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 ≤ 300 mmHg while the patient is breathing oxygen at a flow rate of 10 liters per minutes or more
* A partial pressure of arterial carbon dioxide (PaCO2) not higher than 45 mmHg
* An absence of clinical history of underlying chronic respiratory failure

Exclusion Criteria:

* A do-not-intubate order
* Pregnant or lactating woman
* Cardiogenic pulmonary edema
* Exacerbation of asthma
* Hemodynamic instability with use of vasopressor at significant dose (norepinephrine \> 0.5 mg/h)
* A Glasgow Coma Scale of 12 points of less
* Contraindications to non-invasive ventilation
* Urgent need for endotracheal intubation
* High flow oxygen therapy started within 48 hours before inclusion
* Patient under legal protection or deprived of liberty

Where it's running

• Brest, University Hospital
  Brest, France Recruiting
• AP-HP - Hôpital Louis Mourier
  Colombes, France Not yet recruiting
• AP-HP - Hôpital Henri Mondor
  Créteil, France Not yet recruiting
• CH Morlaix
  Morlaix, France Not yet recruiting
• CHR Orléans
  Orléans, France Not yet recruiting
• CH Poitiers
  Poitiers, France Not yet recruiting

Study contacts

• Study coordinator: Laetitia BODENES, Dr
• Email: laetitia.bodenes@chu-brest.fr
• Phone: +33 2 30 33 76 78

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.