Respiratory FailureNCT07161271
Retrospective Cohort Study of Low-Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) System: Evaluating ECCO2R's Efficacy and Safety in Participants With Respiratory Failure
An observational study of Respiratory Failure and ICU, run by Hong Kong University at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, ICU, Asthma (Diagnosis)
- How many people
- 59 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients supported with ECCO2R in our designated study sites
Who may be able to join
- Patients supported with ECCO2R in one of the designated study sites
- Admitted to the ICU between 1 Jan 2022 and 30 June 2024
Who cannot join
- Patients younger than 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital (QMH)
Hong Kong
Wai Ching Simon Sin, Director, Clinical Professor, (852) 9090-8772, drwcsin@hku.hk
About this study
Official title: Retrospective Cohort Study of Low-Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) System: Evaluating Efficacy and Safety
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.
Read the 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.
- Conditions
- Respiratory Failure, ICU, Asthma (Diagnosis), ARDS
- Keywords
- ECCO2R, ICU, Asthma, ARDS, Respiratory failure
- Medical subject headings
- Respiratory Insufficiency, Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From November 2024 to September 2026 (Anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Sin Wai-ching, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161271
- Sponsor's protocol ID
- UW 24-480
- Other IDs
- HKU/HA HKW IRB
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34463700Brodie 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.
PubMed 31408142Barbic 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.
PubMed 38190699Giraud 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.
PubMed 33709318Zhou 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.
PubMed 36856550Morelli 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.
PubMed 28132075
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study of Low-Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) System: Evaluating Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07161271
- Acronym / sponsor ID
- UW 24-480
- Conditions
- Respiratory Failure, ICU, Asthma (Diagnosis), ARDS
- Keywords
- ECCO2R, ICU, Asthma, ARDS, Respiratory failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Hong Kong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients supported with ECCO2R in our designated study sites
Key inclusion criteria (2 listed)
- Patients supported with ECCO2R in one of the designated study sites
- Admitted to the ICU between 1 Jan 2022 and 30 June 2024
Key exclusion criteria (1 listed)
- Patients younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Around 60 participants with respiratory failure as assessed for their clinical characteristics and outcomes
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 34463700McNamee 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.
- Results publication: PubMed 31408142Brodie 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.
- Results publication: PubMed 38190699Barbic 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.
- Results publication: PubMed 33709318Giraud 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.
- Results publication: PubMed 36856550Zhou 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.
- Results publication: PubMed 28132075Morelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and ICU, run by Hong Kong University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wai Ching Simon Sin, Director, Clinical Professor ((852)9090-8772, drwcsin@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Around 60 participants with respiratory failure as assessed for their clinical characteristics and outcomes (time frame: From November 2024 to September 2026 (Anticipated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07161271, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.