ROX Index in Acute Respiratory Failure

March 25, 2022 updated by: Kholoud Zakaria, Assiut University

Role of ROX Index as an Indicator for Non-invasive Ventilation in Acute Respiratory Failure

evaluation of ROX index among ICU patients to evaluate the success of non invasive ventilation or the need for intubation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients administered in chest ICU in Assiut university hospital

Description

Inclusion Criteria:

  • Participants admitted to RICU with type I and type II respiratory failure requiring NIV support with one or more of the following :

    1. PaO2/FiO2 less than or equal to 300 mmHg despite supplying oxygen at a flow rate ≥ to 10 l/min for ≥ 15 min
    2. Patients requiring ventilatory support due to increased respiratory rate ≥ 25 breaths/min or using accessory muscles of respiration

Exclusion Criteria:

  • 1. Absolute indication for intubation like coma, hemodynamic instability, or life-threatening arrhythmia.

    2. Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy,or active upper gastrointestinal bleeding.

    3. Resusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success vs failure of non invasive ventilation
Time Frame: within 6 months
by ROX index calculation
within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESTROX

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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