NCT02606240

Brief Summary

This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

November 11, 2015

Last Update Submit

August 5, 2017

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.

    Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.

    24 hours

Secondary Outcomes (8)

  • Assessment of changes in Vt

    24 hours

  • Assessment of changes in Plateau Pressure

    24 hours

  • Assessment of changes in respiratory rate

    24 hours

  • Assessment of changes in Positive End-Expiratory Pressure, PEEP

    24 hours

  • Change in vasopressor use

    24 hours

  • +3 more secondary outcomes

Study Arms (1)

Mild to Moderate ARDS on PRISMALUNG

Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device in patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS).

Device: CO2 removal with PRISMALUNG in ARDS

Interventions

CO2 removal with PRISMALUNG in ARDSDEVICE

Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.

Mild to Moderate ARDS on PRISMALUNG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mild to Moderate ARDS according to the Berlin definition of ARDS

You may qualify if:

  • Mechanical ventilation with expected duration of \>24 hours
  • Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg \<PaO2/FiO2 \<300 mmHg, with PEEP \> 5 cmH2O

You may not qualify if:

  • Age \<18 years
  • Pregnancy
  • Severe hypoxemia with PaO2/FiO2 \<100 mmHg
  • Body mass index \> 40 kg/m2
  • Decompensated heart insufficiency or acute coronary syndrome
  • Severe Chronic obstructive pulmonary disease (COPD)
  • Major respiratory acidosis with PaCO2 \>60 mmHg
  • Acute brain injury
  • Severe liver insufficiency (Child-Pugh scores \>7) or fulminant hepatic failure
  • Heparin-induced thrombocytopenia
  • Contraindication for systemic anticoagulation
  • Patient moribund, decision to limit therapeutic interventions
  • Catheter access to femoral vein or jugular vein impossible
  • Pneumothorax
  • Platelet \<50 G/L
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU AMIENS, Département Anesthésie Réanimation

Amiens, France

Location

CHU Besançon, Réanimation

Besançon, France

Location

CHU CLERMONT FERRAND, Département Anesthésie Réanimation

Clermont-Ferrand, France

Location

CHU MONTPELLIER, Département Anesthésie Réanimation

Montpellier, France

Location

Hopital Pitié Salpetriere, Reanimation Medicale

Paris, 75013, France

Location

Related Publications (1)

  • Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.

    PMID: 29743094DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Intensive Care Medicine, MD, PhD

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 17, 2015

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

FR(5)