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

Not Applicable

• Conditions: Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
• Interventions: Device: Prone position during non-invasive respiratory support

• Registration Number: NCT04306107
• Lead Sponsor: Hospital General Universitario Morales Meseguer

Brief Summary

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

Detailed Description

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)

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-30
• Study Start: 2021-09-01
• Primary Completion: 2021-11-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV with prone position	Prone position during non-invasive respiratory support	Use of prone position during NIV
HFNC (conventional)	Prone position during non-invasive respiratory support	HFNC on conventional position
NIV (conventional)	Prone position during non-invasive respiratory support	NIV on conventional position
HFNC on prone position	Prone position during non-invasive respiratory support	Prone position during HFNC

Primary Outcome Measures

Name	Time	Method
Oro-tracheal entubation	1 month	Oro-tracheal entubation avoidance

Secondary Outcome Measures

Name	Time	Method
PaO2/FiO2	1 month	Effect of prone position on PaO2/FiO2