Value of Volume Oxygenation Index to Detect Early Failure of Non-invasive Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

July 10, 2025 updated by: Entsar Hsanen, Assiut University

Non-invasive ventilation (NIV) is an evidence-based treatment for patients with acute respiratory failure due to an exacerbation of Chronic Obstructive Pulmonary Disease (COPD). In patients with COPD and acute hypercapnic respiratory failure, NIV improves gas exchange, reduces the work of breathing, and decreases the length of hospital stay and mortality [1]. Furthermore, when compared to invasive ventilation, NIV leads to fewer complications, such as ventilator-related infections [2]. These findings have resulted in guideline recommendations for the use of NIV in acute respiratory failure due to an exacerbation of COPD [3].NIV failure has been defined as the need for endotracheal intubation (ETI) or death. Its rate varies greatly between 5% and 60%, depending on numerous factors [4].

The Volume Oxygenation (VOX) index, initially developed to predict treatment failure of high flow nasal cannula therapy, has demonstrated the ability to estimate early increases in respiratory drive. Within the first 2 h, the VOX index exhibits a discriminative potential of 0.88 (95 % CI 0.79-0.97) in predicting HFNC failure [5]. Based on this premise, we hypothesize that the VOX index could be a predictive tool for NIV treatment failure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

190

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participants will be subjected to Complete history taking, including demographic characteristics, diagnosis on admission to the hospital, length of ICU stay, length of hospital stay, and chronic underlying diseases. Vital signs, complete lab investigation, APACHE II, and SOFA score will be collected. Non-invasive pressure support ventilation (PSV) mode will be used, using pressure support 15 mmH2o to calculate the VTm (average of three consecutive VT monitoring values / Predicted Body Weight). Arterial blood gases will be collected at admission, and within 2 hours of NIV, and after 24h of NIV to calculate the VOX index [6].

VOX index =SpO2 / (FiO2 * VTm).

Description

Inclusion Criteria:

  • All patients diagnosed with COPD admitted to the respiratory ICU for NIV.

Exclusion Criteria:

  • Patients indicated for urgent intubation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Invasive mechanical ventilation
Time Frame: 1 week
deterioration and invasive ventilation
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in hospital mortality
Time Frame: 1 week
patient death
1 week

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 (Estimated)

July 15, 2025

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

June 28, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • volume oxygenation index COPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on COPD

Clinical Trials on non invasive ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe