Predicting Success of HFNC: The Utility of the ROX Index

July 12, 2016 updated by: Hospital Universitari Vall d'Hebron Research Institute

Predicting Failure of High Flow Nasal Cannula in Pneumonia Patients With Hypoxemic Respiratory Failure: The Utility of ROX Index

The purpose of the study was to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation in pneumonia patients with acute respiratory failure treated with High Flow nasal cannula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose The purpose of the study is to describe early predictors and to develop a prediction tool that accurately identifies the need for mechanical ventilation (MV) in pneumonia patients with hypoxemic acute respiratory failure (ARF) treated with high-flow nasal cannula (HFNC).

Materials and methods This is a 4-year prospective observational 2-center cohort study including patients with severe pneumonia treated with HFNC. High-flow nasal cannula failure was defined as need for MV. ROX index was defined as the ratio of pulse oximetry/fraction of inspired oxygen to respiratory rate.

Study Type

Observational

Enrollment (Actual)

201

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with acute respiratory failure admitted to intensive care unit receiving high-flow nasal cannula treatment.

Description

Inclusion Criteria:

  • diagnosis of acute respiratory failure secondary to pneumonia receiving HFNC therapy

Exclusion Criteria:

  • younger than 18 years old
  • indication for mechanical ventilation at ICU admission
  • limitation of therapeutic effort

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exit
HFNC with no need for mechanical ventilation
failure
HFNC with need for mechanical ventilation
Procedure: mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prediction of need for mechanical ventilation using ROX index
Time Frame: through study completion, an average of 1 year
participants will be followed during their stay in the ICU registering the days with HFNC treatment and their need or not for mechanical ventilation.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

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

January 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)101/2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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