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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prone position during non-invasive respiratory support
Sponsored by
Hospital General Universitario Morales Meseguer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure focused on measuring Noninvasive ventilation, High-flow nasal oxygen therapy, Prone position

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    NIV with prone position

    NIV (conventional)

    HFNC on prone position

    HFNC (conventional)

    Arm Description

    Use of prone position during NIV

    NIV on conventional position

    Prone position during HFNC

    HFNC on conventional position

    Outcomes

    Primary Outcome Measures

    Oro-tracheal entubation
    Oro-tracheal entubation avoidance

    Secondary Outcome Measures

    PaO2/FiO2
    Effect of prone position on PaO2/FiO2

    Full Information

    First Posted
    March 10, 2020
    Last Updated
    August 26, 2021
    Sponsor
    Hospital General Universitario Morales Meseguer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04306107
    Brief Title
    Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy
    Acronym
    ProPNIVFlow
    Official Title
    Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2021 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Morales Meseguer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
    Keywords
    Noninvasive ventilation, High-flow nasal oxygen therapy, Prone position

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NIV with prone position
    Arm Type
    Experimental
    Arm Description
    Use of prone position during NIV
    Arm Title
    NIV (conventional)
    Arm Type
    Placebo Comparator
    Arm Description
    NIV on conventional position
    Arm Title
    HFNC on prone position
    Arm Type
    Experimental
    Arm Description
    Prone position during HFNC
    Arm Title
    HFNC (conventional)
    Arm Type
    Placebo Comparator
    Arm Description
    HFNC on conventional position
    Intervention Type
    Device
    Intervention Name(s)
    Prone position during non-invasive respiratory support
    Other Intervention Name(s)
    HFNC and NIV application with patient on prone position
    Intervention Description
    HFNC and NIV application with patient on prone position
    Primary Outcome Measure Information:
    Title
    Oro-tracheal entubation
    Description
    Oro-tracheal entubation avoidance
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    PaO2/FiO2
    Description
    Effect of prone position on PaO2/FiO2
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miguel Guia, MD
    Phone
    00351915774975
    Ext
    00351915774975
    Email
    miguelguia7@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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