Mechanical Ventilation ComplicationLUMEDRI-MORTNCT04193254
LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU
An observational study of Mechanical Ventilation Complication and Mechanical Power, run by JOSE IVAN RODRIGUEZ DE MOLINA SERRANO at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Mechanical Power, Driving Pressure
- How many people
- 63 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2019to 1 Mar 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients that required invasive mechanical ventilation.
Who may be able to join
- Patients with 18 years or older, with invasive mechanical ventilation
Who cannot join
- Patients with 17 years or younger
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Zona 11 Imss Piedras Negras Coahuila
Piedras Negras, Coahuila, 26020
About this study
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
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
Read the 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:
- Primary diagnosis
- Compliance with lung protective ventilation
- Complications associated to mechanical ventilation
- Quality of attention indicators for MV patients as defined by Semicyuc.
- Real mortality vs Expected mortality analysis
- Conditions
- Mechanical Ventilation Complication, Mechanical Power, Driving Pressure, Lung Protective Ventilation
- Keywords
- lung protective ventilation, mechanical power, driving pressure, SOFA
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Sept 19-Feb 20
Correlation of driving pressure with mortality and SOFA
Driving Pressure: Quantitative variabel, calculated using: Pplateau pressure-PEEP. nomral range < 13
Measured: Sept 19-Feb 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Sep 2019
- Primary completion28 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- JOSE IVAN RODRIGUEZ DE MOLINA SERRANO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, IMSS Hospital General de Zona 11, Piedras Negras
- Investigators
- JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD, Principal investigator, HGZ 11 IMSS PIEDRAS NEGRAS COAHUILA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193254
- Sponsor's protocol ID
- R-2019-506-010
- Acronym
- LUMEDRI-MORT
- Status last verified
- Apr 2020
- First submitted
- 23 Aug 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04193254
- Acronym / sponsor ID
- LUMEDRI-MORT / R-2019-506-010
- Conditions
- Mechanical Ventilation Complication, Mechanical Power, Driving Pressure, Lung Protective Ventilation
- Keywords
- lung protective ventilation, mechanical power, driving pressure, SOFA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- JOSE IVAN RODRIGUEZ DE MOLINA SERRANOUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Primary diagnosis
- Compliance with lung protective ventilation
- Complications associated to mechanical ventilation
- Quality of attention indicators for MV patients as defined by Semicyuc.
- Real mortality vs Expected mortality analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients that required invasive mechanical ventilation.
Key inclusion criteria (1 listed)
- Patients with 18 years or older, with invasive mechanical ventilation
Key exclusion criteria (1 listed)
- Patients with 17 years or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
Related trials for Mechanical Ventilation Complication
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
Respiratory Insufficiency, Wounds and Injuries
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD principal investigator
HGZ 11 IMSS PIEDRAS NEGRAS COAHUILA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Mechanical Power, run by JOSE IVAN RODRIGUEZ DE MOLINA SERRANO at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Lung protective ventilation with mortality and SOFA (Sequential Organic Failure Assessment) (time frame: Sept 19-Feb 20). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.