NCT02586948

Brief Summary

Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of the respiratory management represents a fundamental challenge for improving prognosis and reducing mortality. While the hospital mortality of patients treated with NIV has decreased over years, and is currently less than 10 %, mortality in patients treated with invasive ventilation remains higher than 25%. To improve the prognosis of patients with acute exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge in terms of morbidity and mortality. Among the means available to achieve this goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach. The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for an acute exacerbation, while improving gas exchange.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

3 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

August 31, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

August 31, 2015

Last Update Submit

February 26, 2018

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

extracorporeal CO2 removal

Outcome Measures

Primary Outcomes (1)

  • intrinsic PEEP (PEEPi)

    PEEPi at baseline and after ECCO2R by the Hemolung® device and adjustment of ventilator settings, expressed in cmH20

    12 hours (between measurements at baseline and under ECCO2R)

Secondary Outcomes (17)

  • Functional Residual capacity (FRC)

    12 hours (between measurements at baseline and under ECCO2R)

  • PaO2

    12 hours (between measurements at baseline and under ECCO2R)

  • PaCO2

    12 hours (between measurements at baseline and under ECCO2R)

  • Arterial O2 saturation

    12 hours (between measurements at baseline and under ECCO2R)

  • pH

    12 hours (between measurements at baseline and under ECCO2R)

  • +12 more secondary outcomes

Study Arms (1)

extracorporeal CO2 removal

EXPERIMENTAL

extracorporeal CO2 removal initiated shortly after intubation, using the veno-venous Hemolung device

Device: extracorporeal CO2 removal (Hemolung device)

Interventions

extracorporeal CO2 removal (Hemolung device)DEVICE

ECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation

Also known as: ECCO2R
extracorporeal CO2 removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical exacerbation of a known or suspected COPD
  • intubation and invasive mechanical ventilation since less than 72 hrs.
  • ACV or CV mode (VT 8 ml/kg, RR 12/min., PEEP : 0 cmH20)
  • pH \< 7.30 and PaCO2 \> 55 mm Hg and PEEPi (end-expiratory occlusion) \> 5 cmH20
  • written inform consent (patient, patient's legal surrogate)
  • affiliation to a social security regime

You may not qualify if:

  • Body Mass Index (BMI) \> 35 kg/m2
  • PaO2/FiO2 \< 200 mm Hg
  • history of hemorrhagic stroke
  • heparin-induced thrombocytopenia
  • Severe thrombopenia type II history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU d'Angers

Angers, 49933, France

Location

Hopital de Bicetre, Hopitaux universitaires Paris Sud

Le Kremlin-Bicêtre, 94275, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

  • Diehl JL, Piquilloud L, Vimpere D, Aissaoui N, Guerot E, Augy JL, Pierrot M, Hourton D, Arnoux A, Richard C, Mancebo J, Mercat A. Physiological effects of adding ECCO2R to invasive mechanical ventilation for COPD exacerbations. Ann Intensive Care. 2020 Sep 29;10(1):126. doi: 10.1186/s13613-020-00743-y.

    PMID: 32990836DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Luc Diehl

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

October 27, 2015

Study Start

July 1, 2016

Primary Completion

January 14, 2018

Study Completion

February 12, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

FR(3)