NCT04193254

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

August 23, 2019

Last Update Submit

April 7, 2020

Conditions

Mechanical Ventilation ComplicationMechanical PowerDriving PressureLung Protective Ventilation

Keywords

lung protective ventilationmechanical powerdriving pressureSOFA

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Correlation of driving pressure with mortality and SOFA

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

    Sept 19-Feb 20

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients that required invasive mechanical ventilation.

You may qualify if:

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

You may not qualify if:

  • Patients with 17 years or younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Zona 11 Imss Piedras Negras Coahuila

Piedras Negras, Coahuila, 26020, Mexico

Location

Study Officials

  • JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD

    HGZ 11 IMSS PIEDRAS NEGRAS COAHUILA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of ICU Jose Ivan RodriguezdeMolina Critical Care Ph.

Study Record Dates

First Submitted

August 23, 2019

First Posted

December 10, 2019

Study Start

September 1, 2019

Primary Completion

February 28, 2020

Study Completion

March 1, 2020

Last Updated

April 9, 2020

Record last verified: 2020-04

Locations

ME(1)