Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

The goal of this clinical trial is to validate the interest of a strategy adjusting the flow rate delivered under high-flow oxygen (HFO) therapy according to the lung volumes measured by a new technique, in intensive care patients with hypoxemic respiratory distress (HRD).

The main question it aims to answer is:

"The use of a technique of measurement of lung pulmonary with adjustement to the flow rate can make it possible to limite intubation in patients with HRD in intensive care?" The participants will be the patients admitted in intensive care for HRD with the need for treatment with HFO.

This participants will be randomized in :

* the arm control: treated by high flow oxygen therapy according to standard procedures. * or in the experimental arm : treated by high flow oxygen therapy with adjustement of ventilatory parametres based on lung volume measurements, obtained by the depth camera.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

A do-not-intubate order

Pregnant or lactating woman

Cardiogenic pulmonary edema

Exacerbation of asthma

Trial design

Design model

Parallel

Treatments tested in this trial

  • high flow oxygen therapy rate adjusted of lung volumes measured

    Drug

    Use of a technique based on non-contact measurement of lung volumes by depth camera in order to optimise the use of hihg flow oxygen therapy, with adaptation of the flow rate.

Treatment groups

406 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: interventionalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Use of intubation within 28 days of randomization

Collection of the use of intubation (Yes/No) in patients

Time frame
from patient randomization to day 90

Secondary outcomes

1

Evaluation of organ dysfunction

daily SOFA score

Time frame
up to 28 days after randomization
2

Evaluation of respiratory therapy

daily ROX Index

Time frame
up to 28 days after randomization
3

Reduced need for ventilatory techniques

Number of days without ventilatory support

Time frame
from inclusion to day 28
4

Mortality

Number of death

Time frame
90 days after inclusion

Other outcomes

Sponsors and contacts

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