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Clinical Trials/NCT05643911
NCT05643911
Recruiting
Not Applicable

Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway in Hypoxemic Critical Care Patients: a Physiological Randomized Controlled Trial

University Hospital, Montpellier1 site in 1 country56 target enrollmentJanuary 27, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
University Hospital, Montpellier
Enrollment
56
Locations
1
Primary Endpoint
Variation in poorly aerated lung volume
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Symptomatic treatment of hypoxemic respiratory failure is a controversial topic with different options: 1) standard oxygen therapy, 2) high flow nasal cannula oxygen therapy (HFNC) and 3) non-invasive ventilation (NIV).

The aim of the study is to compare HFNC versus NIV ventilation using CT scan. The hypothesis of this study is that in hypoxemic critically ill patients, the increase of lung volumes with NIV would be significantly higher than the increase of lung volumes with HFNC.

Registry
clinicaltrials.gov
Start Date
January 27, 2023
End Date
January 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95%
  • Adult (age ≥ 18 years)
  • (2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study.

Exclusion Criteria

  • NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure \< 90 mmHg or mean blood pressure \< 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less)
  • History of recent facial trauma not compatible with the use of nasal cannulas
  • Pregnancy
  • Refusal of study participation
  • protected person
  • Patient not affiliated to the social security system or not benefiting from such a system
  • Lack of signed informed consent

Outcomes

Primary Outcomes

Variation in poorly aerated lung volume

Time Frame: the day of inclusion

The poorly aerated volume will be measured by CT scan

Variation in non-aereted lung volume

Time Frame: the day of inclusion

The non-aereted volume will be measured by CT scan

Secondary Outcomes

  • Variation in cross-sectional upper airway area(the day of inclusion)
  • Variation in Positive End Expiratory Pressure (PEEP)(the day of inclusion)
  • Variation in Total lung volume(the day of inclusion)
  • Variation in respiratory rate(the day of inclusion)
  • Variation in normally aerated lung volume(the day of inclusion)
  • Variation in cardiac output (Qc)(the day of inclusion)
  • Variation in O2 gas exchange(the day of inclusion)
  • Variation in CO2 gas exchange(the day of inclusion)
  • Variation in patient comfort(the day of inclusion)

Study Sites (1)

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