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出境医 / 临床实验 / ECCO2R - Mechanical Power Study

ECCO2R - Mechanical Power Study

Study Description
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.

Condition or disease Intervention/treatment
ARDS, Human Extracorporeal CO2 Removal Mechanical Power Other: Extracorporeal CO2 Removal

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effects of Low Flow Extracorporeal CO2 Removal on Mechanical Power in ARDS Patients
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2024
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Mechanical Power reduction. [ Time Frame: Changes from baseline to day 5. ]

    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))



Secondary Outcome Measures :
  1. Respiratory mechanics. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    1. Respiratory system elastance (Ers) (cmH2O/L) = (airway pressure at end inspiratory pause - airway pressure at PEEP) / tidal volume

  2. Respiratory mechanics. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    2. Lung elastance (El) (cmH2O/L) = (transpulmonary pressure at end inspiratory pause - transpulmonary pressure at PEEP / tidal volume

  3. Respiratory mechanics. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    3. Chest wall elastance (Ecw) (cmH2O/L) = (esophageal pressure at end inspiratory pause - esophageal pressure at PEEP) / tidal volume

  4. Respiratory mechanics. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    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).

  5. Gas exchange. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    Assessment of changes in PaCO2 mmHg.

  6. Gas exchange. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    Assessment of changes in PaO2 mmHg.

  7. Gas exchange. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    Assessment of changes in PaO2/FiO2.

  8. Safety assessment and adverse device related events: frequency of serious adverse events [ Time Frame: Every day, until the fifth day or until the weaning from ECCO2R if lower than five days ]
    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).


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 16, 2019
First Posted Date May 6, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date March 20, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2019) 		Mechanical Power reduction. [ Time Frame: Changes from baseline to day 5. ]
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))
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 3, 2019)
  • Respiratory mechanics. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    1. Respiratory system elastance (Ers) (cmH2O/L) = (airway pressure at end inspiratory pause - airway pressure at PEEP) / tidal volume
  • Respiratory mechanics. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    2. Lung elastance (El) (cmH2O/L) = (transpulmonary pressure at end inspiratory pause - transpulmonary pressure at PEEP / tidal volume
  • Respiratory mechanics. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    3. Chest wall elastance (Ecw) (cmH2O/L) = (esophageal pressure at end inspiratory pause - esophageal pressure at PEEP) / tidal volume
  • Respiratory mechanics. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    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).
  • Gas exchange. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    Assessment of changes in PaCO2 mmHg.
  • Gas exchange. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    Assessment of changes in PaO2 mmHg.
  • Gas exchange. [ Time Frame: Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days ]
    Assessment of changes in PaO2/FiO2.
  • Safety assessment and adverse device related events: frequency of serious adverse events [ Time Frame: Every day, until the fifth day or until the weaning from ECCO2R if lower than five days ]
    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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ECCO2R - Mechanical Power Study
Official Title The Effects of Low Flow Extracorporeal CO2 Removal on Mechanical Power in ARDS Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • ARDS, Human
  • Extracorporeal CO2 Removal
  • Mechanical Power
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).
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Kolobow T, Gattinoni L, Tomlinson T, Pierce JE. An alternative to breathing. J Thorac Cardiovasc Surg. 1978 Feb;75(2):261-6.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 3, 2019) 		15
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2024
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Davide Chiumello, Professor +390281844020 chiumello@libero.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03939260
Other Study ID Numbers 13175/2019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Davide Chiumello, University of Milan
Study Sponsor University of Milan
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Milan
Verification Date May 2019

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