CClinicalTrials.gg
Status unknownNCT04046380Updated Jan 23, 2020

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

An observational study in Acute Respiratory Distress Syndrome, Mechanical Ventilation, Respiratory Mechanics, Ventilator-induced Lung Injury, sponsored by Changhua Christian Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Changhua Christian Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Acute Respiratory Distress Syndrome, Mechanical Ventilation, Respiratory Mechanics, Ventilator-induced Lung Injury
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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Changhua Christian Hospital is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Single ICU in one teaching hospital

Inclusion criteria

  • Intubated patients aged 20 to 90 years old

Exclusion criteria

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • normal lungs

    Diagnostic Test: work of breath measurement and calculation

  • Acute respiratory distress syndrome (ARDS) group

    Diagnostic Test: work of breath measurement and calculation

Interventions

  • Diagnostic testwork 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.

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What researchers measure

Primary outcomes

  1. correlation of calculated and measured work of breath

    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.

    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.

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Study locations

1 of 1 sites recruiting
  • Medical Intensive Care Unit
    Changhua city, 500, Taiwan
    • Cheng-Deng Kuo, MD,PhD · Contact
    Recruiting
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References and documents

Publications

  • Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639. PubMed 25693014 ↗
  • Oba Y, Salzman GA. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury. N Engl J Med. 2000 Sep 14;343(11):813; author reply 813-4. No abstract available. PubMed 10991706 ↗
  • Fan E, Brodie D, Slutsky AS. Acute Respiratory Distress Syndrome: Advances in Diagnosis and Treatment. JAMA. 2018 Feb 20;319(7):698-710. doi: 10.1001/jama.2017.21907. PubMed 29466596 ↗
  • Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x. PubMed 28701178 ↗
  • Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. PubMed 27620287 ↗
  • Tonetti T, Vasques F, Rapetti F, Maiolo G, Collino F, Romitti F, Camporota L, Cressoni M, Cadringher P, Quintel M, Gattinoni L. Driving pressure and mechanical power: new targets for VILI prevention. Ann Transl Med. 2017 Jul;5(14):286. doi: 10.21037/atm.2017.07.08. PubMed 28828361 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04046380
Lead sponsor
Changhua Christian Hospital
Responsible party
Cheng-Deng Kuo (Doctor, Changhua Christian Hospital) — Principal investigator
First posted
Aug 6, 2019
Start date
Aug 15, 2019
Primary completion
Jun 30, 2021 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Jan 23, 2020

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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