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

NCT06837402 | Enrolling By Invitation

• 1 other identifier: 14770
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mechanical ventilation; acute respiratory failure; noninvasive ventilation; intensive care unit

Outcome Measures

Primary Outcomes (2)

• ICU Mortality

  Death that occurs during Hospital stay

  28 days

• Hospital Mortality

  Death that occurs during ICU stay

  28 days

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

Patients admitted to the ICU with NIMV requirements

You may qualify if:

• Patients over 18 years of age.
• Requirement of NIMV in ICU due to acute respiratory failure (hypoxemic or hypercapnic or mixed) or as part of the process of weaning from mechanical ventilation.
• Patients who receive NIMV as a palliative or as part of end-of-life care.
• Patients as a routine treatment who require an increase in the time of use, or the level of support, or both due to increased demand.
• Informed consent signed by the patient or his/her legal representative in the event that the patient is incapacitated.

You may not qualify if:

• Patients admitted to the ICU with NIV as standard treatment for chronic lung disease, neuromuscular disease, obstructive sleep apnea-hypopnea syndrome, or obesity hypoventilation syndrome without additional respiratory compromise.

Sponsors & Collaborators

• Argentinian Intensive Care Society: lead

Study Sites (1)

Hospital Británico de Buenos Aires

CABA, Buenos Aires, 1425, Argentina

Location

Related Publications (39)

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MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gustavo Plotnikow, RT

  Hospital Británico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory Therapist

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 20, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)