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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04193254
Other study ID # R-2019-506-010
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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