ECCO2R - Mechanical Power Study

ARDS, Human Clinical Trial

Official title:

The Effects of Low Flow Extracorporeal CO2 Removal on Mechanical Power in ARDS Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03939260
• Other study ID #: 13175/2019
• Status: Recruiting
• Start date: March 20, 2019
• Est. completion date: March 2024

Study information

• Verified date: May 2019
• Source: University of Milan
• Contact: Davide Chiumello, Professor
• Phone: +390281844020
• Email: chiumello[@]libero.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure <30 cmH2O. Since now there are no studies exploring the application of low flow extracorporeal CO2 removal and ultraprotective ventilation to reduce mechanical power, a composite index of VILI, independently from the value of plateau pressure or the severity of hypercapnia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2024
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

ARDS patients undergoing mechanical ventilation with:

• PaO2/FiO2 <150 with a level of positive end expiratory pressure (PEEP) of 10 cmH2O or higher with a FiO2 > 0.5

• Plateau pressure of 28 cmH2O or higher with tidal volume of 6 ml/Kg of ideal body weight

• Mechanical power of 18 J/min or higher.

Exclusion Criteria:

• <18 years of age

• Pregnancy

• Obesity with BMI> 30

• Platelets <30 G/l

• Decompensated heart failure or acute coronary syndrome

• Acute brain injury

• Contraindication for systemic anticoagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder, recent major surgery)

• Patient moribund, decision to limit therapeutic interventions

• Catheter access to femoral vein or jugular vein impossible

• Pneumothorax.

Related Conditions & MeSH terms

• ARDS, Human
• Extracorporeal CO2 Removal
• Mechanical Power
• Respiratory Distress Syndrome, Adult

Intervention

Other:
• Extracorporeal CO2 Removal
Extracorporeal carbon dioxide removal (ECCO2R), a low flow extracorporeal CO2 removal, may be used in association with ultraprotective mechanical ventilation (tidal volume < 6 ml/kg and Pplat <20-25 cmH2O).

Locations

Country	Name	City	State
Italy	ASST-Santi Paolo e Carlo, San Paolo Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Acute Respiratory Distress Syndrome Network, Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. — View Citation

Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350. — View Citation

Chiumello D, Brochard L, Marini JJ, Slutsky AS, Mancebo J, Ranieri VM, Thompson BT, Papazian L, Schultz MJ, Amato M, Gattinoni L, Mercat A, Pesenti A, Talmor D, Vincent JL. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017 Sep 12;21(1):240. doi: 10.1186/s13054-017-1820-0. Review. — View Citation

Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056. — View Citation

Fan E, Needham DM, Stewart TE. Ventilatory management of acute lung injury and acute respiratory distress syndrome. JAMA. 2005 Dec 14;294(22):2889-96. 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

Kolobow T, Gattinoni L, Tomlinson T, Pierce JE. An alternative to breathing. J Thorac Cardiovasc Surg. 1978 Feb;75(2):261-6. — View Citation

Peek GJ, Clemens F, Elbourne D, Firmin R, Hardy P, Hibbert C, Killer H, Mugford M, Thalanany M, Tiruvoipati R, Truesdale A, Wilson A. CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure. BMC Health Serv Res. 2006 Dec 23;6:163. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Power reduction.	Achievement of Mechanical Power reduction under 18 J/min while maintaining pH and PaCO2 to ± 20% of baseline values obtained at tidal volume of 6 mL/kg.; Mechanical Power (MP) (J/min) = 0.098 * respiratory rate * tidal volume (inspiratory peak airway pressure - 1/2 * (airway pressure at end inspiratory pause - airway pressure at PEEP))	Changes from baseline to day 5.
Secondary	Respiratory mechanics.	1. Respiratory system elastance (Ers) (cmH2O/L) = (airway pressure at end inspiratory pause - airway pressure at PEEP) / tidal volume	Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Secondary	Respiratory mechanics.	2. Lung elastance (El) (cmH2O/L) = (transpulmonary pressure at end inspiratory pause - transpulmonary pressure at PEEP / tidal volume	Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Secondary	Respiratory mechanics.	3. Chest wall elastance (Ecw) (cmH2O/L) = (esophageal pressure at end inspiratory pause - esophageal pressure at PEEP) / tidal volume	Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Secondary	Respiratory mechanics.	4. End inspiratory transpulmonary pressure (cmH2O)= airway pressure at end inspiratory pause - (esophageal pressure at end inspiratory pause - expiration at atmospheric pressure by a release manouvre).	Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Secondary	Gas exchange.	Assessment of changes in PaCO2 mmHg.	Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Secondary	Gas exchange.	Assessment of changes in PaO2 mmHg.	Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Secondary	Gas exchange.	Assessment of changes in PaO2/FiO2.	Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
Secondary	Safety assessment and adverse device related events: frequency of serious adverse events	Safety assessment reporting frequency of serious adverse events in terms of device related mechanical events (Pump malfunction, membrane lung clotting, system leaks, tubing rupture, air in the circuit) and device related clinical events (heamolysis, significant bleeding, thromboembolic complications, neurologic complications, metabolic complications).	Every day, until the fifth day or until the weaning from ECCO2R if lower than five days