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Cross-sectional, Observational, Prospective and Analytical Study:MECHANICAL POWER DAY (MPDay) (MPDay)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936231
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Alejandro Gonzalez Castro, Hospital Universitario Marqués de Valdecilla

Brief Summary:

Recently the new concept of "mechanical power" has been proposed. It refers to the amount of energy per minute that is transferred to the lung by the ventilator. The generation of this form of energy would include both parameters that were previously proposed to be possible causes for lung damage and new parameters that had not been taken into account until now, such as the flow rate or the respiratory rate, without forgetting the individual characteristics of each ventilated subject.

The main objective of the current study is to know the value of the mechanical power in the patient connected to mechanical ventilation, in a volume control model.

This value will be calculated from electronically provided data using the simplified formula by Gattinonni et. al.


Condition or disease Intervention/treatment
Mechanical Ventilation Complication Other: NO Intervention

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2000 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: ASSESSMENT OF THE MECHANICAL POWER TRANSMITTED TO THE PATIENTS WITH MECHANICAL VENTILATION IN INTENSIVE CARE UNITS "MECHANICAL POWER DAY"
Estimated Study Start Date : November 21, 2019
Estimated Primary Completion Date : November 21, 2019
Estimated Study Completion Date : November 21, 2019

Intervention Details:
  • Other: NO Intervention

    Given the observational nature of this study, we consider that no intervention is required.

    Participation in concomitant studies: given the observational condition of this study, patiens that are included in other observational and/or experimental researches, can be included in the current study.



Primary Outcome Measures :
  1. Mechanical Power (MP) (assess the amount of energy per minute that is transferred to the lung by the ventilator) [ Time Frame: One Day ]
    MP=0.098 x Vt x Fr x Pp-(Pplat-PEEP/2)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients that are hospitalised in a critical care area and on mechanical ventilation on the 21st of November 2019.
Criteria

Inclusion Criteria:

  • Patiens with mechanical ventilation in the critical care areas.

Exclusion Criteria:

  • Patients with not mechanical ventilation.
  • Patients with mechanical ventilation for less that 6 hours.
  • Traqueostomy patients
  • APRV or BiLEVEL ventilation mode.
  • Noninvasive ventilation d.n selectiv
  • Selective ling ventilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936231


Locations
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Spain
Alejandro Gonzalez-Castro
Santander, Spain, 39008
Sponsors and Collaborators
Hospital Universitario Marqués de Valdecilla
Additional Information:
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Responsible Party: Alejandro Gonzalez Castro, Critical Care Department, Hospital Universitario Marqués de Valdecilla
ClinicalTrials.gov Identifier: NCT03936231    
Other Study ID Numbers: 2019.040
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro Gonzalez Castro, Hospital Universitario Marqués de Valdecilla:
VILI
Mechanical Power
Driving Pressure
Strain
Stress