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

Sponsor
Changhua Christian Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04046380
Collaborator
(none)
100
1
34.5
2.9

Study Details

Study Description

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 Phase
  • Diagnostic Test: work of breath measurement and calculation

Study Design

Study Type:
Observational
Anticipated 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 :
Aug 15, 2019
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. correlation of calculated and measured work of breath [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Intensive Care Unit Changhua city Taiwan 500

Sponsors and Collaborators

  • Changhua Christian Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cheng-Deng Kuo, Doctor, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT04046380
Other Study ID Numbers:
  • 108-CCH-IRP-081
First Posted:
Aug 6, 2019
Last Update Posted:
Jan 23, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2020