NCT03936231

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

Same day

First QC Date

April 24, 2019

Last Update Submit

May 18, 2019

Conditions

Keywords

VILIMechanical PowerDriving PressureStrainStress

Outcome Measures

Primary Outcomes (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)

    One Day

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patiens with mechanical ventilation in the critical care areas.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alejandro Gonzalez-Castro

Santander, 39008, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Critical Care Department

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 3, 2019

Study Start

November 21, 2019

Primary Completion

November 21, 2019

Study Completion

November 21, 2019

Last Updated

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations