COPDNCT07074210
Value of Volume Oxygenation Index to Detect Early Failure of Non-invasive Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
An observational study of COPD and Non Invasive Ventilation (NIV), run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Non Invasive Ventilation (NIV), VOX Index
- What is being tested?
- non invasive ventilation
- Type of treatment
- Medical device
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- All patients diagnosed with COPD admitted to the respiratory ICU for NIV.
Who cannot join
- Patients indicated for urgent intubation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- non invasive ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive ventilationDevice
Non invasive mechanical ventilation pressure support
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for Invasive mechanical ventilation
deterioration and invasive ventilation
Measured: 1 week
Secondary outcomes (1)
in hospital mortality
patient death
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Entsar Hsanen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074210
- Sponsor's protocol ID
- volume oxygenation index COPD
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Volume Oxygenation Index to Detect Early Failure of Non-invasive Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07074210
- Acronym / sponsor ID
- volume oxygenation index COPD
- Conditions
- COPD, Non Invasive Ventilation (NIV), VOX Index
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- All patients diagnosed with COPD admitted to the respiratory ICU for NIV.
Key exclusion criteria (1 listed)
- Patients indicated for urgent intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non invasive ventilationNon invasive mechanical ventilation pressure support | Device | – |
Primary outcome
Need for Invasive mechanical ventilation
Time frame: 1 week
deterioration and invasive ventilation
1 secondary outcome
in hospital mortality
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Non Invasive Ventilation (NIV), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Entsar Hsanen Mohamed, lecturer (+201019968106, entsar.hsanen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for Invasive mechanical ventilation (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.