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.
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.
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.
- Conditions
- Mechanical Ventilation Complication
- 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.
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.
- First posted3 May 2019
- Study start21 Nov 2019 (estimated)
- Primary completion21 Nov 2019 (estimated)
- Study completion21 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Gonzalez Castro, Hospital Universitario Marqués de Valdecilla
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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF THE MECHANICAL POWER TRANSMITTED TO THE PATIENTS WITH MECHANICAL VENTILATION IN INTENSIVE CARE UNITS "MECHANICAL POWER DAY"
- ClinicalTrials.gov ID
- NCT03936231
- Acronym / sponsor ID
- MPDay / 2019.040
- Conditions
- Mechanical Ventilation Complication
- Keywords
- VILI, Mechanical Power, Driving Pressure, Strain, Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Hospital Universitario Marqués de ValdecillaUniversity, hospital or other
- Study start
- 21 Nov 2019 (estimated)
- Primary completion
- 21 Nov 2019 (estimated)
- Study completion
- 21 Nov 2019 (estimated)
- First posted
- 3 May 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.
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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patiens with mechanical ventilation in the critical care areas.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO InterventionGiven 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. | Other | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 37996266Gonzalez-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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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.