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

Mechanical Ventilation Complication Clinical Trial

— LUMEDRI-MORT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193254
• Other study ID #: R-2019-506-010
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: IMSS Hospital General de Zona 11, Piedras Negras
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 1, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with 17 years or younger

Related Conditions & MeSH terms

• Driving Pressure
• Lung Protective Ventilation
• Mechanical Power
• Mechanical Ventilation Complication

Locations

Country	Name	City	State
Mexico	Hospital General Zona 11 Imss Piedras Negras Coahuila	Piedras Negras	Coahuila

Sponsors (1)

Lead Sponsor	Collaborator
JOSE IVAN RODRIGUEZ DE MOLINA SERRANO

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of Lung protective ventilation with mortality and SOFA (Sequential Organic Failure Assessment)	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
Primary	Correlation of mechanical power with mortality and SOFA	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
Primary	Correlation of driving pressure with mortality and SOFA	Driving Pressure: Quantitative variabel, calculated using: Pplateau pressure-PEEP. nomral range < 13	Sept 19-Feb 20