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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04046380
Other study ID # 108-CCH-IRP-081
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2019
Est. completion date June 30, 2022

Study information

Verified date January 2020
Source Changhua Christian Hospital
Contact Shin Hwar Wu
Phone 8867238595
Email 126366@cch.org.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2022
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan Medical Intensive Care Unit Changhua city

Sponsors (1)

Lead Sponsor Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.