ECCO2R - Mechanical Power Study

May 3, 2019 updated by: Davide Chiumello, University of Milan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20142
        • Recruiting
        • ASST-Santi Paolo e Carlo, San Paolo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
Changes from baseline to day 5.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
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
Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
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
Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
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).
Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
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.
Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
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.
Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
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.
Every six hours, every day until the fifth day or until the weaning from ECCO2R if lower than five days
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).
Every day, until the fifth day or until the weaning from ECCO2R if lower than five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2019

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2024

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (ACTUAL)

May 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13175/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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