Retrospective Cohort Study of Low-Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) System: Evaluating ECCO2R's Efficacy and Safety in Participants With Respiratory Failure

Recruiting

• Conditions: Respiratory Failure; ARDS; ICU; Asthma (Diagnosis)

• Registration Number: NCT07161271
• Lead Sponsor: Hong Kong University

Brief Summary

This is an observational study performed by retrospective review of data routinely collected for patients receiving low-flow extracorporeal carbon dioxide removal (ECCO2R) therapy in intensive care units (ICUs). Our aim is to firstly, describe the local practice in terms of patient selection and technical details of clinical management related to the use of low-flow ECCO2R system, and secondly, the clinical results in terms of patient outcomes and adverse events. These findings may allow clinicians to improve the quality and safety of ECCO2R therapy provision in the ICU.

Detailed Description

Extracorporeal carbon dioxide removal (ECCO2R) is a specialised medical procedure employed to eliminate excessive carbon dioxide (CO2) from the bloodstream. To date, there have been only a few small-scale studies published on ECCO2R, with limited data on the full spectrum of clinical presentations, management strategies, and outcomes. Previous clinical trials have investigated the potential for ECCO2R therapy to reduce the intensity of mechanical ventilation in patients suffering from acute respiratory distress syndrome (ARDS). While these trials have successfully achieved desired physiological outcomes, they have not consistently translated into improved patient mortality rates. Additionally, the use of ECCO2R has presented certain complications, especially when higher-flow ECCO2R systems based on the centrifugal pump technology were used, which had been more extensively studied in the past. However, our clinical experience appeared to suggest that low-flow ECCO2R therapy could be managed with reasonable treatment success rate and limited complications. The investigators hypothesise that the use of low-flow ECCO2R therapy is clinically effective and safe for a selected group of ICU patients with acute respiratory failure.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Patients supported with ECCO2R in one of the designated study sites
• Admitted to the ICU between 1 Jan 2022 and 30 June 2024

Exclusion Criteria

• Patients younger than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Around 60 participants with respiratory failure as assessed for their clinical characteristics and outcomes	From November 2024 to September 2026 (Anticipated)	The primary endpoint is to describe the patients' demographics (e.g. Age, Sex), clinical characteristics (e.g. APACHE score, ventilator using time, respiratory parameters, ventilatory parameters, Mortality), outcomes of patients (death or survive) who received ECCO2R therapy.; The secondary endpoints are to evaluate the association between clinical factors and patient outcomes (e.g. life of stay in ICU, ventilator free days), and to identify potential risk factors for adverse events and complications.

Trial Locations

Locations (1)

Queen Mary Hospital (QMH); 🇭🇰 Hong Kong, Hong Kong