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OpenTrials
Completed

NCT Number: NCT04193254

LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU

Prospective, observational, longitudinal study, September 2019 to March 2020 of all adult patients who required invasive mechanical ventilation treated at General Hospital of Zone 11 IMSS in Piedras Negras, Coahuila. The investigators aim to assess the relation of lung protective ventilation, mechanical power and driving pressure in mortality and SOFA of mechanically ventilated patients inside and outside ICU at the General Hospital of Zona 11 Piedras Negras, IMSS

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Zona 11 Imss Piedras Negras Coahuila

Piedras Negras, Coahuila, 26020, Mexico

About this study

Prospective, observational, longitudinal study from Sept 2019 to Feb 2020 of all adult patients who required invasive mechanical ventilation treated at General Hospital of Zone 11 IMSS in Piedras Negras Coahuila.

Independent variable: Lung protective ventilation, Mechanical power, Driving pressure Dependent variable: Hospital Mortality, Sequential Organic Failure Assessment (SOFA)

Also will be registered:

  • Primary diagnosis
  • Compliance with lung protective ventilation
  • Complications associated to mechanical ventilation
  • Quality of attention indicators for MV patients as defined by Semicyuc.
  • Real mortality vs Expected mortality analysis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with 18 years or older, with invasive mechanical ventilation

Exclusion criteria

  • Patients with 17 years or younger

Treatment and study plan

Primary outcomes

  1. Correlation of Lung protective ventilation with mortality and SOFA (Sequential Organic Failure Assessment)

    Time frame: Sept 19-Feb 20

    Lung Protective Ventilation: Qualitative variable will be defined as YES or NO with the averages of the daily measurements of tidal volume and Pressure plateau. It is defined as Tidal volume (Vc or Vt) <8 ml / kg (ideal weight) and Plateau or plateau pressure (Ppl, Pm) <30cmH2O

  2. Correlation of mechanical power with mortality and SOFA

    Time frame: Sept 19-Feb 20

    Mechanical power: Quantitative variable. calculated using Marinni equation: MP= (0.098)x(Plateau pressure-PEEP)x Respiratory Rate xTidal Volume. Normal range < 13

  3. Correlation of driving pressure with mortality and SOFA

    Time frame: Sept 19-Feb 20

    Driving Pressure: Quantitative variabel, calculated using: Pplateau pressure-PEEP. nomral range < 13

Sponsors and collaborators

Lead sponsor

Jose Ivan Rodriguez de Molina Serrano

Other

Registry information

Official study title

Relation of Pulmonary Protective Ventilation, Mechanical Power and Driving Pressure With Mortality and SOFA of Mechanically Ventilated Patients in ER, Ward and ICU at General Hospital 11 IMSS Piedras Negras, Coahuila

Acronym: LUMEDRI-MORT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2019
Registry last updated
Apr 9, 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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