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

NCT ID: NCT04046380

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-15

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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normal lungs

work of breath measurement and calculation

Intervention Type DIAGNOSTIC_TEST

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

work of breath measurement and calculation

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheng-Deng Kuo

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical Intensive Care Unit

Changhua, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shin Hwar Wu

Role: CONTACT

8867238595 ext. 3971

Facility Contacts

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Cheng-Deng Kuo, MD,PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25693014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10991706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29466596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28701178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27620287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28828361 (View on PubMed)

Other Identifiers

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108-CCH-IRP-081

Identifier Type: -

Identifier Source: org_study_id

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