NCT04306107

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

March 10, 2020

Last Update Submit

August 26, 2021

Conditions

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

Keywords

Noninvasive ventilationHigh-flow nasal oxygen therapyProne position

Outcome Measures

Primary Outcomes (1)

  • Oro-tracheal entubation

    Oro-tracheal entubation avoidance

    1 month

Secondary Outcomes (1)

  • PaO2/FiO2

    1 month

Study Arms (4)

NIV with prone position

EXPERIMENTAL

Use of prone position during NIV

Device: Prone position during non-invasive respiratory support

NIV (conventional)

PLACEBO COMPARATOR

NIV on conventional position

Device: Prone position during non-invasive respiratory support

HFNC on prone position

EXPERIMENTAL

Prone position during HFNC

Device: Prone position during non-invasive respiratory support

HFNC (conventional)

PLACEBO COMPARATOR

HFNC on conventional position

Device: Prone position during non-invasive respiratory support

Interventions

Prone position during non-invasive respiratory supportDEVICE

HFNC and NIV application with patient on prone position

Also known as: HFNC and NIV application with patient on prone position
HFNC (conventional)HFNC on prone positionNIV (conventional)NIV with prone position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with:
  • ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)

You may not qualify if:

  • General NIV or HFNC contraindications
  • Immediate need for IOT
  • Prone position intolerance
  • Patients refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Miguel Guia, MD

CONTACT

00351915774975miguelguia7@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 12, 2020

Study Start

September 1, 2021

Primary Completion

November 1, 2021

Study Completion

May 1, 2022

Last Updated

August 30, 2021

Record last verified: 2021-08