ECCO2R - Mechanical Power Study

NCT03939260 | Unknown

• 1 other identifier: 13175/2019
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ARDS, Human; Extracorporeal CO2 Removal; Mechanical Power

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Respiratory mechanics.

  Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days

• Respiratory mechanics.

  Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days

• Respiratory mechanics.

  Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days

• Respiratory mechanics.

  Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days

• Gas exchange.

  Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days

Interventions

Extracorporeal CO2 Removal OTHER

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult respiratory distress syndrome (ARDS) patients, affected by a life-threatening condition characterized by nonhydrostatic pulmonary edema that can be caused by pulmonary (eg, pneumonia, aspiration) or nonpulmonary (eg, sepsis, pancreatitis, trauma) insults and accounts for 10% of intensive care unit (ICU) admissions. Mortality remains high ranging from 35% to 46% and it has been estimated that at least 150,000 individuals die each year of adult respiratory distress syndrome.

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST-Santi Paolo e Carlo, San Paolo Hospital

Milan, 20142, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 26903337 BACKGROUND

• 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. doi: 10.1001/jama.294.22.2889.

  PMID: 16352797 BACKGROUND

• 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. doi: 10.1056/NEJM200005043421801.

  PMID: 10793162 BACKGROUND

• 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.

  PMID: 28899408 BACKGROUND

• 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.

  PMID: 27620287 BACKGROUND

• 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.

  PMID: 26872367 BACKGROUND

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

  PMID: 625133 BACKGROUND

• 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. doi: 10.1186/1472-6963-6-163.

  PMID: 17187683 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Davide Chiumello, Professor

CONTACT

+390281844020; chiumello@libero.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 6, 2019
• Study Start: March 20, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2024
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

IT (1)