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

NCT07074210 | Not Yet Recruiting DMC

• 1 other identifier: volume oxygenation index COPD
• Study Type: observational
• Target: 190
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Need for Invasive mechanical ventilation

  deterioration and invasive ventilation

  1 week

Secondary Outcomes (1)

• in hospital mortality

  1 week

Interventions

non invasive ventilation DEVICE

Non invasive mechanical ventilation pressure support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Patients indicated for urgent intubation

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Entsar Hsanen Mohamed, lecturer

CONTACT

+201019968106; entsar.hsanen@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 20, 2025
• Study Start: July 15, 2025
• Primary Completion: January 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-06