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Completed

NCT Number: NCT04107467

Mechanical Ventilation Epidemiology in Argentina.

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

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Key information

Conditions

Respiration, Artificial Epidemiology Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Fiorito, Avellaneda, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Survival in the ICU

    Time frame: Up to 28 days after the enrollment

    "Survival in the ICU" will be measured as YES or NO at day 28 after the enrollment.

Secondary outcomes

  1. Main reason of Invasive Mechanical Ventilation

    Time frame: 1 day

    • 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).
    • 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.
    • Coma: A)Metabolic, B)Overdose, Intoxication, C)Stroke, D)Brain trauma.
    • Neuromuscular disease

  2. Ventilatory Modes and setting

    Time frame: Up to 10 days

    Volume Control Ventilation, Pressure Control Ventilation, Pressure Support Ventilation, Synchronized Intermittent Mandatory Ventilation, Other (Proportional Assist Ventilation, Neurally Adjusted Ventilation, Airway Pressure Release Ventilation)

  3. Tidal Volume

    Time frame: Up to 10 days

    Set tidal volume in mililiters

  4. Weaning and mortality

    Time frame: Up to 28 days

    Weaning characteristics and outcome of the patient in terms of mortality.

  5. Noninvasive ventilation during weaning and mortality

    Time frame: Up to 28 days

    The use of NIV during weaning and the outcome of the patient in terms of mortality

  6. Incidence of delirium

    Time frame: Up to 28 days

    Delirium measured with the CAM- ICU.

  7. Incidence of ICU acquired weakness

    Time frame: Up to 28 days

    Periphereal muscle weakness measured with MRC defined as a total value of less than 48 points.

  8. Incidence of tracheostomy

    Time frame: Up to 28 days

    Presence of tracheostomy

  9. Sedation and analgesia in mechanical ventilation

    Time frame: Up to 28 days

    Implementation of sedation and analgesia during the period of mechanical ventilation.

  10. Peak Pressure

    Time frame: Up to 10 days

    Monitored Peak Pressure in centimeters of water

  11. Plateau Pressure

    Time frame: Up to 10 days

    Monitored Plateau Pressure in centimeters of water

  12. Applied PEEP

    Time frame: Up to 10 days

    Set PEEP in centimeters of water

  13. Total PEEP

    Time frame: Up to 10 days

    Monitored total PEEP in centimeters of water

  14. Driving Pressure

    Time frame: Up to 10 days

    Monitored Driving Pressure in centimeters of water as the difference between Total PEEP and Plateau Pressure in centimeters of water

Sponsors and collaborators

Lead sponsor

Argentinian Intensive Care Society

Other

Registry information

Official study title

Mechanical Ventilation Epidemiology in Argentina. EpVAr Multicenter Study.

Acronym: EpVAr2019

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2019
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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