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

NCT06837402 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 246

Last updated 2025-05-31

No results posted yet for this study

Summary

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.

Conditions

  • Respiration, Artificial
  • Noninvasive Ventilation
  • Intensive Care Units

Sponsors & Collaborators

  • Argentinian Intensive Care Society

    lead OTHER

Principal Investigators

  • Gustavo Plotnikow, RT · Hospital Británico

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-12-01
Completion
2026-04-01

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06837402 on ClinicalTrials.gov