A Modified Mathematical Model to Calculate Power Received by Mechanically Ventilated Patients With Different Etiologies

January 21, 2020 updated by: Cheng-Deng Kuo, Changhua Christian Hospital
Ventilator-induced lung injury is a common complication. The latest and most noticeable theory of its pathogenesis is called 'ergotrauma' by Gattinoni in 2016. The theory uses ventilator-imposed 'energy' or 'power' to encompass several known forms of injury-inducing factors such as pressure,volume, flow, rate, etc. However, to quantify power imposed by ventilator is no easy task in clinical practice. So, Gattinoni proposed a mathematical formula for easy power calculation. However, Gattinoni did not compare the difference between various etiologies of acute lung injury. We will enroll 100 patients (50 with acute respiratory distress syndrome and 50 with normal lung). The ventilator-imposed power at various tidal volume (6, 8, 10 ml/Kg) and positive end-expiratory pressure (5, 10 cmH2O) will be calculated by the formula. The area enclosed by hysteresis of pressure-volume curve, and hence the work it implies, will be measured as a standard. Our study will aim to compare the formula in different patient groups and in Taiwanese people.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua city, Taiwan, 500
        • Recruiting
        • Medical Intensive Care Unit
        • Contact:
          • Cheng-Deng Kuo, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Single ICU in one teaching hospital

Description

Inclusion Criteria:

  • Intubated patients aged 20 to 90 years old

Exclusion Criteria:

  • Fraction of inspired oxygen (FiO2) higher than 60%
  • Acute physiology and chronic health evaluation (APACHE) II score more than 30
  • Plateau pressure or peak airway pressure more than 30 cmH2O
  • High risk for barotrauma
  • Unstable hemodynamic status
  • Under airway pressure release ventilation or high frequency oscillation ventilation therapy
  • Under extra-corporeal membrane oxygenation support
  • On prone position

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
normal lungs
Diagnostic test: work of breath measurement and calculation
The ventilator-imposed power at various tidal volume (6, 8, 10 ml/Kg) and positive end-expiratory pressure (5, 10 cmH 2 O) will be calculated by the formula.
Acute respiratory distress syndrome (ARDS) group
Diagnostic test: work of breath measurement and calculation
The ventilator-imposed power at various tidal volume (6, 8, 10 ml/Kg) and positive end-expiratory pressure (5, 10 cmH 2 O) will be calculated by the formula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of calculated and measured work of breath
Time Frame: The measurement and calculation will be performed only once when the ventilator was in use. The estimated time frame of measurement is less than one hour.
The ventilator-imposed power at various tidal volume (6, 8, 10 ml/Kg) and positive end-expiratory pressure (5, 10 cmH 2 O) will be calculated by the formula.
The measurement and calculation will be performed only once when the ventilator was in use. The estimated time frame of measurement is less than one hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108-CCH-IRP-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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