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

NCT ID: NCT07074210

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-07-15

Brief Summary

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.

Conditions

COPD; Non Invasive Ventilation (NIV); VOX Index

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

non invasive ventilation

Non invasive mechanical ventilation pressure support

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients indicated for urgent intubation

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

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Entsar Hsanen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Entsar Hsanen Mohamed, lecturer

Role: CONTACT

entsar.hsanen@aun.edu.eg

+201019968106

Other Identifiers

volume oxygenation index COPD

Identifier Type: -

Identifier Source: org_study_id