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

NCT ID: NCT04306107

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-05-01

Brief Summary

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

Detailed Description

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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)

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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NIV with prone position

Use of prone position during NIV

Group Type EXPERIMENTAL

Prone position during non-invasive respiratory support

Intervention Type DEVICE

HFNC and NIV application with patient on prone position

NIV (conventional)

NIV on conventional position

Group Type PLACEBO_COMPARATOR

Prone position during non-invasive respiratory support

Intervention Type DEVICE

HFNC and NIV application with patient on prone position

HFNC on prone position

Prone position during HFNC

Group Type EXPERIMENTAL

Prone position during non-invasive respiratory support

Intervention Type DEVICE

HFNC and NIV application with patient on prone position

HFNC (conventional)

HFNC on conventional position

Group Type PLACEBO_COMPARATOR

Prone position during non-invasive respiratory support

Intervention Type DEVICE

HFNC and NIV application with patient on prone position

Interventions

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Prone position during non-invasive respiratory support

HFNC and NIV application with patient on prone position

Intervention Type DEVICE

Other Intervention Names

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HFNC and NIV application with patient on prone position

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Morales Meseguer

OTHER

Sponsor Role lead

Responsible Party

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Miguel Filipe Martins de Matos Navarro Guia

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Miguel Guia, MD

Role: CONTACT

00351915774975 ext. 00351915774975

Other Identifiers

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10-03-2020 2

Identifier Type: OTHER

Identifier Source: secondary_id

10-03-2020

Identifier Type: -

Identifier Source: org_study_id

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