Strategy of UltraProtective Lung Ventilation With Extracorporeal CO2 Removal for New-Onset Moderate to seVere ARDS

Summary

Pathophysiological, experimental and clinical data suggest that an '"ultraprotective" mechanical ventilation strategy may further reduce VILI and ARDS-associated morbidity and mortality. Severe hypercapnia induced by VT reduction in this setting might be efficiently controlled by ECCO2R devices. A proof-of-concept study conducted on a limited number of ARDS cases indicated that ECCO2R allowing VT reduction to 3.5-5 ml/kg to achieve Pplat\<25 cm H2O may further reduce VILI.

Conditions

• Moderate Acute Respiratory Distress Syndrome

Interventions

DEVICE

ECCO2R will be initiated during the 2-hour run-in time

A single (15.5 to 19 Fr) veno-venous ECCO2R catheter will be inserted percutaneously (jugular vein strongly suggested). Catheters should be rinsed with heparinized saline solution before insertion Once the catheter has been inserted each line will be filled with an heparinized saline solution before its connection to the extracorporeal circuit The ECCO2R circuit will be connected to the catheter and blood flow set, depending on the device, up to 1000 mL/min. Initially, sweep gas flow through the ECCO2R device will be set at zero (0 LPM) such as to not initiate CO2 removal through the device. Anticoagulation will be maintained with unfractionated heparin to a target aPTT of 1.5 - 2.0X baseline. A bolus of heparin is suggested at the time of cannulation.

OTHER

Neuromuscular blocking agents (NMBA)

Patients will receive NMBA starting in the run-in period and continued for the first 24 hours and thereafter will be directed by the attending physician

DEVICE

Ventilation

Following the 2-hour run-in time, VT will be reduced gradually to 5 mL/kg. Sweep gas initiated then VT decreased to 4.5 then 4 mL/kg and PEEP adjusted to reach 23 ≤ Pplat ≤ 25 cm H2O.

OTHER

Level of carbon dioxide released at the end of expiration

EtCO2 will be monitored for safety purposes. Blood gases will be analyzed 20-30 minutes after each VT reduction

OTHER

Respiratory Rate

RR will be kept what it was at baseline

OTHER

Sweep gas flow

Sweep gas flow will be adapted to maintain the same EtCO2

OTHER

Ventilation will be adapted

If PaCO2\> 75 mmHg and/or pH \< 7.2, despite respiratory rate of 35/min and optimized ECCO2R, VT will be increased to the last previously tolerated VT.

OTHER

Respiratory rate will be adapted

If PaCO2 remains within the target range, respiratory rate will be progressively decreased to a minimum of 15/ min and facilitated by increases in sweep flow.

Sponsors & Collaborators

• European Society of Intensive Care Medicine

  lead OTHER

Principal Investigators

• Alain COMBES, PhD · La pitié-Salpétrière Hospital

• Marco RANIERI, PhD · University of Turin S.Giovanni Battista Molinette Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2017-07-31

Completion

2017-07-30

Countries

• Belgium