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Mechanical Ventilation Epidemiology in Argentina.

Mechanical Ventilation Epidemiology in Argentina. EpVAr Multicenter Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04107467
Acronym
EpVAr2019
Enrollment
950
Registered
2019-09-27
Start date
2019-09-09
Completion date
2019-12-31
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidemiology, Respiration, Artificial

Brief summary

How is the epidemiology of mechanically ventilated patients in the intensive care units of Argentina?

Detailed description

Mechanical ventilation is an indispensable tool in life support and one of the interventions that characterizes intensive care units (ICU). Epidemiological studies have allowed us to improve knowledge and optimize the treatment of patients with acute respiratory failure. In Latin America the epidemiological data of mechanical ventilation is poor. Primary goal of this national, observational, prospective, multicentric epidemiological study: to analyze the survival and describe epidemiological features of patients receiving mechanical ventilation in the Intensive Care Units of Argentina.

Interventions

None listed

Sponsors

Argentinian Intensive Care Society
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ICU patients requiring Mechanical Ventilation at least for 12 hours * ICU patients who initiate Mechanical Ventilation in the Operation Room or the Emergency Room * ICU patients who initiate Mechanical Ventilation in other institution.

Exclusion criteria

* Patients under 18 years old * Patients in Pediatric ICU * Patients in Coronary ICU * Patients without requirements of Mechanical Ventilation * Patients who have been discharged from ICU and re-enter during the enrollment period

Design outcomes

Primary

MeasureTime frameDescription
Survival in the ICUUp to 28 days after the enrollmentSurvival in the ICU will be measured as YES or NO at day 28 after the enrollment.

Secondary

MeasureTime frameDescription
Ventilatory Modes and settingUp to 10 daysVolume Control Ventilation, Pressure Control Ventilation, Pressure Support Ventilation, Synchronized Intermittent Mandatory Ventilation, Other (Proportional Assist Ventilation, Neurally Adjusted Ventilation, Airway Pressure Release Ventilation)
Tidal VolumeUp to 10 daysSet tidal volume in mililiters
Weaning and mortalityUp to 28 daysWeaning characteristics and outcome of the patient in terms of mortality.
Noninvasive ventilation during weaning and mortalityUp to 28 daysThe use of NIV during weaning and the outcome of the patient in terms of mortality
Incidence of deliriumUp to 28 daysDelirium measured with the CAM- ICU.
Incidence of ICU acquired weaknessUp to 28 daysPeriphereal muscle weakness measured with MRC defined as a total value of less than 48 points.
Main reason of Invasive Mechanical Ventilation1 day1. Acute respiratory failure in patient with chronic respiratory failure: A)Chronic Obstructive Pulmonary Disease, B) Asthma, C) Other Chronic Obstructive Pulmonary Disease (Idiopathic pulmonary fibrosis, Cystic Fibrosis, Interstitial disease). 2. Acute Respiratory Failure: A) Acute Respiratory Distress Syndrome, B) Postoperative, C) Acute Heart Failure, D) Aspiration, E) Pneumonia, F) Sepsis, G) Trauma, H) Cardiac arrest, I)Others. 3. Coma: A)Metabolic, B)Overdose, Intoxication, C)Stroke, D)Brain trauma. 4. Neuromuscular disease
Sedation and analgesia in mechanical ventilationUp to 28 daysImplementation of sedation and analgesia during the period of mechanical ventilation.
Peak PressureUp to 10 daysMonitored Peak Pressure in centimeters of water
Plateau PressureUp to 10 daysMonitored Plateau Pressure in centimeters of water
Applied PEEPUp to 10 daysSet PEEP in centimeters of water
Total PEEPUp to 10 daysMonitored total PEEP in centimeters of water
Driving PressureUp to 10 daysMonitored Driving Pressure in centimeters of water as the difference between Total PEEP and Plateau Pressure in centimeters of water
Incidence of tracheostomyUp to 28 daysPresence of tracheostomy

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026