NCT06837402: EpVAr-VMNI

Epidemiology of Non- Invasive Mechanical Ventilation in Argentina: a Multicenter Observational Study

ENROLLING BY INVITATION Last updated 31 May 2025

What this trial tests

trial in Respiration, Artificial in 246 participants. Enrolling by invitation.

Timeline

1 May 2025

Primary endpoint
1 December 2025

1 April 2026

Quick facts

Lead sponsor	Argentinian Intensive Care Society
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	246
Start date	1 May 2025
Primary completion	1 December 2025
Estimated completion	1 April 2026
Sites	1 location across Argentina

Conditions studied

• Respiration, Artificial — all drugs for Respiration, Artificial →
• Noninvasive Ventilation — all drugs for Noninvasive Ventilation →
• Intensive Care Units — all drugs for Intensive Care Units →

Sponsor

Argentinian Intensive Care Society

Who can join

18 and older, any sex, with Respiration, Artificial or Noninvasive Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction Non-invasive mechanical ventilation (NIMV) is a fundamental strategy in the management of acute respiratory failure, preventing intubation and reducing complications. However, the epidemiology of its use in Argentina is not well understood, motivating this study.

Justification Unequal access to ICU resources in Argentina affects the quality of care. This study aims to describe the implementation, effectiveness, and outcomes of NIMV across different regions of the country to improve clinical decision-making and healthcare policies.

Objectives

* Primary: Analyze the survival of ICU patients receiving NIMV.
* Secondary: Evaluate success/failure factors, regional disparities in resource availability, the impact of healthcare staff training, comparison between public and private sectors, and establish a national database.

Methods Study Design Observational, multicenter, prospective, and analytical study. Both public and private hospitals in Argentina will be included. Data will be collected over seven months, with patient follow-up until discharge or death.

Study Population Adult patients (\>18 years) admitted to the ICU requiring NIMV for acute respiratory failure or as part of weaning from invasive mechanical ventilation.

Inclusion Criteria

* Age \>18 years.
* Use of NIMV in the ICU for respiratory failure or during weaning.
* Signed informed consent.

Exclusion Criteria

* Patients using home NIMV without exacerbation.
* Patients without acute respiratory impairment.

Data Collection and Management

* Data will be recorded using an electronic form in RedCap®, with restricted access.
* Confidentiality will be ensured through alphanumeric coding.
* A monitoring committee will supervise data quality.

Statistical Analysis

* Continuous variables: Mean and standard deviation or median and interquartile range.
* Comparisons: Student's t-test, Mann-Whitney U test, Chi² test, or Fisher's exact test.
* Multivariate models: Logistic regression and Kaplan-Meier survival analysis.

Bias Control and Data Quality Strategies will be implemented to minimize selection, information, and investigator bias. Data will be periodically reviewed by the monitoring committee.

Study Feasibility The study is supported by the British Hospital of Buenos Aires and the Argentine Society of Intensive Care Medicine, ensuring its viability.

Ethical Considerations The study will comply with national and international health research regulations, ensuring participant confidentiality.

Publication and Funding The study will be funded by the Argentine Society of Intensive Care Medicine, with no external financial support. Authorship in publications will depend on the number of patients included per center.

Conclusion This study aims to generate key information on NIMV use in Argentina, optimizing its application and improving ICU care nationwide.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.