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Mechanical Ventilation ComplicationMPDayNCT03936231

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

An observational study of Mechanical Ventilation Complication, run by Hospital Universitario Marqués de Valdecilla at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Mechanical Ventilation Complication
How many people
2,000 participants
Where
1 siteSpain
Study dates
21 Nov 2019to 21 Nov 2019
How long will I take part?
1 Day
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients that are hospitalised in a critical care area and on mechanical ventilation on the 21st of November 2019.

Who may be able to join

  • Patiens with mechanical ventilation in the critical care areas.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Alejandro Gonzalez-Castro

    Santander, 39008

Other trials in Spain

About this study

Official title: ASSESSMENT OF THE MECHANICAL POWER TRANSMITTED TO THE PATIENTS WITH MECHANICAL VENTILATION IN INTENSIVE CARE UNITS "MECHANICAL POWER DAY"

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.

Read the detailed description

Introduction and justification:

Over the last few years the investigators have witnessed an important technological developement in the field of mechanical ventilation. Along with the technological advances, the better understanding of the respiratory physiopathology has shown that mechanical ventilation "per se" can lead to deleterious effects.

In this context, the search for those variables which are responsible for the developing of ventilator-induced lung injury (VILI) has become an important goal in this field. In fact, the investigators are witnessing the nearly exponential increase in the publication of studies that have tried to associate the different parameters that intervene in mechanical ventilation with the injury to the lung structure.

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.

12J/min has been stablished experimentally as the energy threshold from where changes in the lung that can lead to VILI begin to appear. Nevertheless, the true issue would be to get to know the best way to normalize the mechanical power value. However, it seems reasonable to think that the values of energy originating VILI in experimental animal models and in humans are different.

Nowadays, in spite of the wide range of monitoring systems that the investigators have, the investigators still don´t know the real mechanical power that the investigators are transmitting to our patients. The different research teams that have deepened into the subject have seen themselves forced to infer their results from retrospective data and from very selected samples of patients immersed in different studies. As one of the first steps in the way of a better understanding of the impact of "mechanical power", the investigators believe it is justified to develope a descriptive and observational study to get to know the real mechanical power value the investigators ventilate our patients in the ICU with.

Objective and hypothesis:

Clinical guides and recommendations aimed at improving ventilation basing on the characteristics of the different pathologies in order to minimize VILI do exist, but the fact remains that the threshold of mechanical power in mechanical ventilation is still unkown.

The main hypothesis of the present study is that the mechanical power received by the patients who need mechanical ventilation in the intensive care unis is greater tan the threshold that has been established by experimental models.

Moreover, the investigators think that mechanical power varies considerably depending on the current and previous pathology of the patient and the days on mechanical ventilation.

Resting on the previous hypothesis, the main objective of the current study is:

  • 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.

Secondary objectives are:

  • Analyze the epidemiology of different modalities in ventilatory, not just VC, on the basis of the collected variables.
  • To assess if the transmitted mechanical power varies depending on the pathology, on the days on mechanical ventilation or on the reason that leads to the need for mechanical ventilation.
  • In case of a ventilatory mode which allows spontaneus breathing, the investigators can see the variability of the plateau pressure and if the investigators can infer its value in the calculation of mechanical power.
  • To know the driving pressure and the ventilatory ratio of ventiled patients.
  • To establish differences among the main analysed parameters depending on the type of critical carea area studied.

Design and methodology:

Cross-sectional, observational, prospective and analytical study. The variables of the study will be collected on a fixed date as agreed with the participating ICU. These variables will be registered during the period of time between 8 am to 15 pm on the 21st of November 2019, in order to adjust to the normal working routine at an intensive care unit.

Sample selection:

All patients that are hospitalised in a critical care unit and on mechanical ventilation on the 21st of November 2019.

Inclusion criteria:

All the patients hospitalised in a crital care unit who are on invasive mechanical ventilation, whatever the cause.

Being tested
NO Intervention
Keywords
VILI, Mechanical Power, Driving Pressure, Strain, Stress
Medical subject headings
Sprains and Strains

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NO InterventionOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mechanical Power (MP) (assess the amount of energy per minute that is transferred to the lung by the ventilator)

    MP=0.098 x Vt x Fr x Pp-(Pplat-PEEP/2)

    Measured: One Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start21 Nov 2019 (estimated)
  3. Primary completion21 Nov 2019 (estimated)
  4. Study completion21 Nov 2019 (estimated)

Resources

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
Case crossover
Time perspective
Cross-sectional
Enrolment
2,000 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03936231
Sponsor's protocol ID
2019.040
Acronym
MPDay
Status last verified
May 2019
First submitted
24 Apr 2019
Last updated
21 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gonzalez-Castro A, Medina Villanueva A, Escudero-Acha P, Fajardo Campoverdi A, Gordo Vidal F, Martin-Loeches I, Rocha AR, Romero MC, Hernandez Lopez M, Ferrando C, Protti A, Modesto I Alapont V; Mechanical Power Day Group. Comprehensive study of mechanical power in controlled mechanical ventilation: Prevalence of elevated mechanical power and component analysis. Med Intensiva (Engl Ed). 2024 Mar;48(3):155-164. doi: 10.1016/j.medine.2023.11.004. Epub 2023 Nov 22.

    PubMed 37996266

Questions about this trial

What is this clinical trial studying?

An observational study of Mechanical Ventilation Complication, run by Hospital Universitario Marqués de Valdecilla at 1 site in Spain.

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 6 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: status not confirmed, as of the sponsor's last update on 21 May 2019. 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 Spain. 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?

Results are not available in the source record.

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?

Mechanical Power (MP) (assess the amount of energy per minute that is transferred to the lung by the ventilator) (time frame: One Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03936231, which also lists 1 linked publication.

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 21 May 2019.

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