Predicting Success of HFNC: The Utility of the ROX Index

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834325
• Other study ID #: PR(AG)101/2011
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: July 12, 2016
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: July 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Pneumonia
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• mechanical ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prediction of need for mechanical ventilation using ROX index	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	No