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

Completed

• Conditions: Lung Protective Ventilation; Driving Pressure; Mechanical Ventilation Complication; Mechanical Power

• Registration Number: NCT04193254
• Lead Sponsor: JOSE IVAN RODRIGUEZ DE MOLINA SERRANO

Brief 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

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 Timeline

• Study First Submitted: 2019-08-23
• Study Start: 2019-09-01
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

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

Exclusion Criteria

• Patients with 17 years or younger

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital General Zona 11 Imss Piedras Negras Coahuila; 🇲🇽 Piedras Negras, Coahuila, Mexico