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

NCT ID: NCT06715644

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-02-01

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.

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).

Conditions

Respiratory Failure

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group 1

patients with respiratory failure treated with high flow nasal cannula

No interventions assigned to this group

group 2

patients with respiratory failure treated with noninvasive ventilation in

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Ramadan Abd el rahman Ibraheim

resident doctor at Chest Diseases and Tuberculosis department Faculty of Medicine, Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Esraa Ramadan Abd el rahman Ibraheim, resident doctor

Role: CONTACT

Phone: +201032164070

Email: rmdanasra024@gmail.com

Other Identifiers

ROX mROX HFNC RF

Identifier Type: -

Identifier Source: org_study_id