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

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

— ProPNIVFlow  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04306107
• Other study ID #: 10-03-2020
• Secondary ID: 10-03-2020 2
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2021
• Source: Hospital General Universitario Morales Meseguer
• Contact: Miguel Guia, MD
• Phone: 00351915774975
• Email: miguelguia7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Prone position during non-invasive respiratory support
HFNC and NIV application with patient on prone position

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Morales Meseguer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oro-tracheal entubation	Oro-tracheal entubation avoidance	1 month
Secondary	PaO2/FiO2	Effect of prone position on PaO2/FiO2	1 month