NCT07161271

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress57%
Nov 2024Jun 2027

Study Start

First participant enrolled

November 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

December 23, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

August 20, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

ECCO2RICUAsthmaARDSRespiratory failure

Outcome Measures

Primary Outcomes (1)

  • Around 60 participants with respiratory failure as assessed for their clinical characteristics and outcomes

    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.

    From November 2024 to September 2026 (Anticipated)

Study Arms (1)

Patients with respiratory failure and supported with ECCO2R

Patients supported with ECCO2R in one of the designated study sites; Admitted to the ICU between 1 Jan 2022 and 30 June 2024; Patients older than 18 years old

Eligibility Criteria

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

Patients supported with ECCO2R in our designated study sites

You may qualify if:

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

You may not qualify if:

  • Patients younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital (QMH)

Hong Kong, Hong Kong

RECRUITING

Related Publications (6)

  • McNamee JJ, Gillies MA, Barrett NA, Perkins GD, Tunnicliffe W, Young D, Bentley A, Harrison DA, Brodie D, Boyle AJ, Millar JE, Szakmany T, Bannard-Smith J, Tully RP, Agus A, McDowell C, Jackson C, McAuley DF; REST Investigators. Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypoxemic Respiratory Failure: The REST Randomized Clinical Trial. JAMA. 2021 Sep 21;326(11):1013-1023. doi: 10.1001/jama.2021.13374.

  • Brodie D, Slutsky AS, Combes A. Extracorporeal Life Support for Adults With Respiratory Failure and Related Indications: A Review. JAMA. 2019 Aug 13;322(6):557-568. doi: 10.1001/jama.2019.9302.

  • Barbic B, Bianchi C, Madotto F, Sklar MC, Karagiannidis C, Fan E, Brochard L. The Failure of Extracorporeal Carbon Dioxide Removal May Be a Failure of Technology. Am J Respir Crit Care Med. 2024 Apr 1;209(7):884-887. doi: 10.1164/rccm.202309-1628LE. No abstract available.

  • Giraud R, Banfi C, Assouline B, De Charriere A, Cecconi M, Bendjelid K. The use of extracorporeal CO2 removal in acute respiratory failure. Ann Intensive Care. 2021 Mar 11;11(1):43. doi: 10.1186/s13613-021-00824-6.

  • Zhou Z, Li Z, Liu C, Wang F, Zhang L, Fu P. Extracorporeal carbon dioxide removal for patients with acute respiratory failure: a systematic review and meta-analysis. Ann Med. 2023 Dec;55(1):746-759. doi: 10.1080/07853890.2023.2172606.

  • Morelli A, Del Sorbo L, Pesenti A, Ranieri VM, Fan E. Extracorporeal carbon dioxide removal (ECCO2R) in patients with acute respiratory failure. Intensive Care Med. 2017 Apr;43(4):519-530. doi: 10.1007/s00134-016-4673-0. Epub 2017 Jan 28.

MeSH Terms

Conditions

Respiratory InsufficiencyAsthmaDisease

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Wai Ching Simon Sin, Director, Clinical Professor

CONTACT

SI CHEN, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor; Director and Clinical Associate Professor

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 8, 2025

Study Start

November 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

December 23, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations