ROX Index Versus MROX Index to Predict Treatment Outcome for High Flow Nasal Cannula And/or Noninvasive Ventilation in Patients with Respiratory Failure

One of managing steps in respiratory failure is high flow nasal cannula (HFNC), but the exact time to turn to invasive machine ventilation (IMV) is necessarily being determined. Respiratory rate and oxygenation (ROX) index, defined as the ratio of oxygen saturation as measured by pulse oximetry (SO2)/ FiO2 to respiratory rate (RR), is used to determine when to intubate the patients who are on HFNC and prevent the delayed intubation. Modified Respiratory rate and oxygenation (mROX), defined as (PaO2/ FiO2) / respiratory rate, is also used to point the time of intubation in case HFNC of patients with respiratory failure . The diagnostic and prognostic accuracy of both parameters are reported in previous papers, but the preference of them is under research. In this study, we aim to observe and compare the diagnostic accuracy between ROX and mROX in determine the time of invasive mechanical ventilation.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure

Detailed Description

Respiratory Failure (RF) is a condition where there's insufficient oxygenation in the body tissue, whether acute, chronic or acute on chronic; occurring due to decreased oxygen or excessive carbon-dioxide in the blood . There are four types of respiratory failure; Hypoxemic respiratory failure (Type1), hypercapnic respiratory failure (Type2), ) . Causes of RF are varied and accounted for any abnormality related upper respiratory tract, lower respiratory tract, central and peripheral nervous system or muscles of respiration . However, in the last three decades, the most common causes of RF is acute myocardial infarction (AMI), acute respiratory distress syndrome (ARDS), RF related to corona virus (Covid-19) and acute exacerbation of chronic obstructive lung disease (COPD).

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Esraa Ramadan Abd el rahman Ibraheim, resident doctor; Phone Number: +201032164070; Email: rmdanasra024@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient diagnosed with acute type 1or 2 or chronic type 1or 2 respiratory failure.

Description

Inclusion Criteria:

• Adult patients of both sex aged between 18 to 80 years
• Patient diagnosed with acute type 1or 2 or chronic type 1or 2 respiratory failure.
• Patient for chest ICU admission
• Patient for HFNC and/ or Noninvasive mechanical ventilation.

Exclusion Criteria:

• Pediatric patients
• Pregnant females
• Patients who are for intubation on ICU admissionc.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group 1; patients with respiratory failure treated with high flow nasal cannula
group 2; patients with respiratory failure treated with noninvasive ventilation in

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic accuracy of ROX in determine the time of invasive mechanical ventilation.	Sensitivity and Specificity in determine the time of invasive mechanical ventilation.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic accuracy mROX index in determine the time of invasive mechanical ventilation.	Sensitivity and Specificity of mROX index in determine the time of invasive mechanical ventilation.	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: noninvasive ventilation; high flow nasal cannula; ROX index; mROX index
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: ROX mROX HFNC RF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No