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

NCT06715644 | Not Yet Recruiting DMC

• 1 other identifier: ROX mROX HFNC RF
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Respiratory Failure

Keywords

ROX index; mROX index; high flow nasal cannula; noninvasive ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• diagnostic accuracy mROX index in determine the time of invasive mechanical ventilation.

  baseline

Study Arms (2)

group 1

patients with respiratory failure treated with high flow nasal cannula

group 2

patients with respiratory failure treated with noninvasive ventilation in

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Esraa Ramadan Abd el rahman Ibraheim, resident doctor

CONTACT

+201032164070; rmdanasra024@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Chest Diseases and Tuberculosis department Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-11