Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation

COPD Exacerbation Acute Clinical Trial

Official title:

Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation: a Single Center Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882410
• Other study ID #: 0004_CohorteECCO2R
• Status: Completed
• Start date: January 2010
• Est. completion date: February 2020

Study information

• Verified date: May 2021
• Source: Centre Hospitalier de Saint-Denis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Acute exacerbation of chronic obstructive pulmonary disease (ae-COPD) has a gold standard treatment: non-invasive ventilation (NIV). However, this treatment sometime fails, and an invasive mechanical ventilation (IMV) is required. The extracorporeal CO₂ removal (ECCO₂R) device can be an alternative to intubation. The aim of the study is to evaluate ECCO₂R efficiency and safety and enlighten ECCO₂R benefit/risk compared to IMV.

Methods: Successive ae-COPD patients for whom NIV failed were retrospectively analyzed during two periods: before and after the ECCO₂R device implementation in our ICU in 2015. We considered the before period as standard of care and patients were treated with IMV. The ECCO₂R device was a pump-driven veno-venous system (Xenios AG).

Description:

The study compare 2 strategies for COPD patients not responding to non invasive ventilation: the gold standard which is mechanical ventilation and a new technique which is extracorporeal CO2 removal. This technique have been implemented in februrary 2015 in our intensive care unit so we choose to compare patients' outcome before and after the arriving of this device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years old

• no improvement or worsening of respiratory acidosis after more than one hour of non invasive ventilation treatment

• and non improvement of respiratory distress signs

• and pH < 7,35 and PaCO2 > 45 mmHg

Exclusion Criteria:

• patients not eligible for endotracheal intubation because of ethical limitations

Related Conditions & MeSH terms

• COPD Exacerbation Acute

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Saint-Denis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for invasive mechanical ventilation despite ECCO2R technique	Rate of patients who needed invasive mechanical ventilation despite ECCO2R technique	From the begining of the ECCO2R treatment until the end of the ICU hospitalization, up to 6months
Secondary	ECCO2R efficiency	pH	During the treatment up to 6months
Secondary	ECCO2R efficiency	PaCO2	During the treatment up to 6months
Secondary	Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalization	Rate of complications related to ECCO2R and invasive mechanical ventilation: hemorrhagic, thrombotic, haemodynamic, ventilator associated pneumonia, self extubation, death	During the ICU hospitalization up to 6months
Secondary	ICU and hospital length of stay	Length of stay in ICU and hospital	From the entrance in ICU until the end of hospitalization in ICU and hospital up to 6months
Secondary	Mortality at day 28 and day 90	Mortality at day 28 and day 90	From the entrance in ICU until day 90