Predicting Success of HFNC: The Utility of the ROX Index

Completed

• Conditions: Acute Respiratory Failure; Pneumonia
• Interventions: Procedure: mechanical ventilation

• Registration Number: NCT02834325
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-08-31
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-12
• Last Update Submitted: 2016-07-12
• Study First Posted: 2016-07-15
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
failure	mechanical ventilation	HFNC with need for mechanical ventilation

Primary Outcome Measures

Name	Time	Method
prediction of need for mechanical ventilation using ROX index	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.