LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU (LUMEDRI-MORT)

April 7, 2020 updated by: JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, Jose Ivan Rodriguez de Molina Serrano

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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:

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

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Coahuila
      • Piedras Negras, Coahuila, Mexico, 26020
        • Hospital General Zona 11 Imss Piedras Negras Coahuila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients that required invasive mechanical ventilation.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with 17 years or younger

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Sept 19-Feb 20
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
Sept 19-Feb 20
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
Sept 19-Feb 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose Ivan Rodriguez de Molina Serrano

Investigators

  • Principal Investigator: JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, HGZ 11 IMSS PIEDRAS NEGRAS COAHUILA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ACTUAL)

February 28, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

December 6, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-2019-506-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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