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NCT Number: NCT07074210

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients indicated for urgent intubation

Treatment and study plan

Non invasive ventilation

Device

Non invasive mechanical ventilation pressure support

Primary outcomes

  1. Need for Invasive mechanical ventilation

    Time frame: 1 week

    deterioration and invasive ventilation

Secondary outcomes

  1. in hospital mortality

    Time frame: 1 week

    patient death

Study contacts

Contact information is provided by the study sponsor or research team.

Entsar Hsanen Mohamed, lecturer

CONTACT

[email protected]

+201019968106

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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