Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy

Study Overview
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Brief Summary
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The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients.

Detailed Description
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Inclusion Criteria: Adult patients with: • ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level) Exclusion Criteria General NIV or HFNC contraindications Immediate need for IOT Prone position intolerance Patients refusal to participate Interventions: Prone position for 2-4 hours twice a day, for 3 days (first 3 days since admission to ICU) Nurse surveilance: at least every 15 minutes Outcomes: Need for IOT Effects on the measurements specified above (particularly PaO2/FiO2)

Official Title
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Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy

Conditions
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Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure

Intervention / Treatment
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* Device: Prone position during non-invasive respiratory support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with: ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level) Exclusion Criteria: General NIV or HFNC contraindications Immediate need for IOT Prone position intolerance Patients refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIV with prone position<br>Use of prone position during NIV | Device: Prone position during non-invasive respiratory support<br>* HFNC and NIV application with patient on prone position<br>* Other names: HFNC and NIV application with patient on prone position;|
| Placebo Comparator: NIV (conventional)<br>NIV on conventional position | Device: Prone position during non-invasive respiratory support<br>* HFNC and NIV application with patient on prone position<br>* Other names: HFNC and NIV application with patient on prone position;|
| Experimental: HFNC on prone position<br>Prone position during HFNC | Device: Prone position during non-invasive respiratory support<br>* HFNC and NIV application with patient on prone position<br>* Other names: HFNC and NIV application with patient on prone position;|
| Placebo Comparator: HFNC (conventional)<br>HFNC on conventional position | Device: Prone position during non-invasive respiratory support<br>* HFNC and NIV application with patient on prone position<br>* Other names: HFNC and NIV application with patient on prone position;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oro-tracheal entubation | Oro-tracheal entubation avoidance | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 | Effect of prone position on PaO2/FiO2 | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive ventilation, High-flow nasal oxygen therapy, Prone position