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Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation

NCT07785375 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-08-25

No results posted yet for this study

Summary

This study will evaluate whether adding extracorporeal carbon dioxide removal (ECCO2R) to noninvasive ventilation can improve breathing in adults hospitalized with a severe worsening of chronic obstructive pulmonary disease (COPD). Participants will have high carbon dioxide levels and increased acidity in their blood despite treatment with noninvasive ventilation and will not be eligible for invasive mechanical ventilation through a breathing tube.

A total of 14 participants will be assigned by chance to receive either noninvasive ventilation alone or noninvasive ventilation together with ECCO2R. ECCO2R removes carbon dioxide directly from the blood through a catheter placed in a large vein. The main aim is to determine whether adding ECCO2R reduces the breathing rate within 4 hours. The study will also assess blood carbon dioxide and acidity, duration of noninvasive ventilation, length of hospital stay, survival, and complications related to ECCO2R.

Conditions

  • Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

DEVICE

Extracorporeal Carbon Dioxide Removal

Low-flow extracorporeal carbon dioxide removal will be provided using the Prismalung+ membrane connected to the PrisMax 2 system. Treatment will be initiated within 12 hours after randomization through a 13- to 14-Fr double-lumen venous catheter. The initial sweep gas flow will be 10 L/min, and blood flow will be set as high as tolerated by the system, with a target of approximately 450 mL/min. Treatment settings will be adjusted according to carbon dioxide removal and arterial pH.

DEVICE

Noninvasive Ventilation

Noninvasive ventilation will be delivered according to current clinical guidelines and usual clinical practice. Ventilator settings and duration of treatment will be adjusted by the treating clinical team according to the participant's respiratory status and clinical response.

Sponsors & Collaborators

  • Hospital del Mar Research Institute (IMIM)

    lead OTHER

Principal Investigators

  • Francisco José Parrilla Gómez, MD, PhD · Hospital del Mar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2028-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785375 on ClinicalTrials.gov