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Not yet recruiting NCT07074210

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

Observational COPD Non Invasive Ventilation (NIV) VOX Index

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: non invasive ventilation.
Who it may be relevant to
Registry conditions: COPD, Non Invasive Ventilation (NIV), VOX Index. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device non invasive ventilation
    Non invasive mechanical ventilation pressure support

Primary outcome measures

  • Need for Invasive mechanical ventilation [Time frame: 1 week]
Secondary outcome measures (1)
  • in hospital mortality [Time frame: 1 week]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Patients indicated for urgent intubation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07074210 · volume oxygenation index COPD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗