ECCO2R - Mechanical Power Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-20

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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ARDS, Human Extracorporeal CO2 Removal Mechanical Power

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No