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

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ClinicalTrials.gov Identifier: NCT04046380
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Cheng-Deng Kuo, Changhua Christian Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome, Mechanical Ventilation, Respiratory Mechanics, Ventilator-induced Lung Injury Diagnostic Test: work of breath measurement and calculation

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Modified Mathematical Model to Calculate Power Received by Mechanically Ventilated Patients With Different Etiologies
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single ICU in one teaching hospital
Criteria

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

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): NCT04046380


Contacts
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Contact: Shin Hwar Wu 8867238595 ext 3971 126366@cch.org.tw

Locations
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Taiwan
Medical Intensive Care Unit Recruiting
Changhua city, Taiwan, 500
Contact: Cheng-Deng Kuo, MD,PhD         
Sponsors and Collaborators
Changhua Christian Hospital
Publications:
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Responsible Party: Cheng-Deng Kuo, Doctor, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT04046380    
Other Study ID Numbers: 108-CCH-IRP-081
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries