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

August 26, 2021 updated by: Miguel Filipe Martins de Matos Navarro Guia, Hospital General Universitario Morales Meseguer
The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NIV with prone position
Use of prone position during NIV
Device: Prone position during non-invasive respiratory support
HFNC and NIV application with patient on prone position
Other Names:
  • HFNC and NIV application with patient on prone position
PLACEBO_COMPARATOR: NIV (conventional)
NIV on conventional position
Device: Prone position during non-invasive respiratory support
HFNC and NIV application with patient on prone position
Other Names:
  • HFNC and NIV application with patient on prone position
EXPERIMENTAL: HFNC on prone position
Prone position during HFNC
Device: Prone position during non-invasive respiratory support
HFNC and NIV application with patient on prone position
Other Names:
  • HFNC and NIV application with patient on prone position
PLACEBO_COMPARATOR: HFNC (conventional)
HFNC on conventional position
Device: Prone position during non-invasive respiratory support
HFNC and NIV application with patient on prone position
Other Names:
  • HFNC and NIV application with patient on prone position

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Morales Meseguer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (ACTUAL)

March 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-03-2020
  • 10-03-2020 2 (OTHER: International Association Noninvasive Ventilation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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