ARDS (Acute Respiratory Distress Syndrome)Cath-CORNCT07858136
The Effect of Catheter Size on the Efficacy of Ultralow-flow Extracorporeal Carbon Dioxide Removal System in Acute Respiratory Distress Syndrome
A study testing 12F Catheter, 13F Catheter and 15F Catheter in people with ARDS (Acute Respiratory Distress Syndrome), run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This pilot randomized controlled trial will evaluate whether catheter size affects the efficacy and performance of ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) and hypercapnic respiratory acidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- 12F Catheter, 13F Catheter and 15F Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2026to 30 Dec 2029
- Phase
- Interventional
- 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
Who may be able to join
- Participants must meet all of the following criteria:
- Age ≥18 years.
- Acute respiratory distress syndrome (ARDS), mild to moderate severity, with a PaO₂/FiO₂ ratio of 100-300 while receiving PEEP ≥5 cmH₂O, after initiation of mechanical ventilation within the preceding 72 hours.
- Hypercapnic respiratory acidosis, defined by PaCO₂ >60 mmHg and/or arterial blood gas pH <7.25 due to respiratory acidosis despite mechanical ventilation exceeding the protocol-defined lung-protective strategy, characterized by one or more of the following:
- Driving pressure >15 cmH₂O;
- Plateau pressure >27 cmH₂O;
- Tidal volume >6 mL/kg predicted body weight; or
- Mechanical power >17 J/min associated with respiratory rate >25 breaths/min.
Who cannot join
- Severe shock that is preload non-responsive and requires norepinephrine >1 µg/kg/min.
- Acute brain injury or cerebral edema, increased intracranial pressure, status epilepticus, intracerebral hemorrhage, or acute ischemic stroke.
- Pregnancy.
- Morbid obesity with BMI >40 kg/m².
- Chronic respiratory acidosis.
- End-stage cancer patients.
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- Coagulation disorders, defined as a platelet count of less than 10,000 cells/mm3 or an INR greater than 3.
- Patients undergoing targeted temperature management for 24 hours after return of spontaneous circulation.
- End-stage renal disease (ESRD) patients with a blood urea nitrogen (BUN) level greater than 60 mg/dL.
- Patients or legal representatives who do not consent to participation.
- Patients with an indication for ECMO according to the EOLIA trial criteria, specifically a PF ratio < 50 mmHg more than 3 hours or a PF ratio < 80 mmHg more than 6 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Chulalongkorn university
Bangkok, Bangkok, 10330
Nattachai Srisawat, Prof. Dr., 02 256 4000 Ext. 3597, 3678, drnattachai@yahoo.com
Phruet Soipetkasem, MD, 0612708090, phruetsoi@gmail.com
About this study
Official title: The Effect of Catheter Size on the Efficacy of Ultralow-flow Extracorporeal Carbon Dioxide Removal System in Acute Respiratory Distress Syndrome: a Pilot Randomized Controlled Trial
This pilot randomized controlled trial will evaluate whether catheter size affects the efficacy and performance of ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) and hypercapnic respiratory acidosis. Participants will be randomly assigned to receive ECCO₂R using a 12F, 13F, or 15F catheter. The primary outcome is the percentage change in PaCO₂ from baseline during ECCO₂R. Secondary outcomes include achievement and time to correction of hypercapnic respiratory acidosis, changes in PaO₂, circuit lifespan, maximum blood flow, and device- and patient-related complications.
Read the detailed description
Acute respiratory distress syndrome (ARDS) may require lung-protective mechanical ventilation to reduce ventilator-induced lung injury. However, limiting tidal volume, driving pressure, plateau pressure, respiratory rate, and mechanical power may result in hypercapnia and respiratory acidosis in some patients.
Ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) may facilitate carbon dioxide removal while allowing maintenance of a lung-protective or ultra-protective ventilatory strategy. Compared with conventional high-flow extracorporeal carbon dioxide removal, ultra-low-flow ECCO₂R can be performed using smaller vascular catheters.
The efficacy of ultra-low-flow ECCO₂R may be influenced by catheter size because catheter diameter affects vascular resistance and achievable blood flow through the extracorporeal circuit. However, the optimal catheter size for achieving effective carbon dioxide removal while minimizing catheter-related risks remains uncertain.
This study is a prospective, randomized, three-arm pilot study. Adult patients with ARDS and hypercapnic respiratory acidosis who meet predefined criteria despite lung-protective mechanical ventilation will be randomly assigned to receive ultra-low-flow ECCO₂R using a 12F, 13F, or 15F catheter.
Participants will undergo ECCO₂R for a minimum of 72 hours or until predefined criteria for discontinuation are met. Blood flow will initially be set within the protocol-defined range and increased incrementally according to PaCO₂ response and hemodynamic safety parameters.
The study will evaluate the effect of catheter size on carbon dioxide removal, correction of hypercapnic respiratory acidosis, oxygenation, circuit lifespan, maximum blood flow, and patient- and device-related complications.
- Being tested
- 12F Catheter, 13F Catheter, 15F Catheter
- Keywords
- ARDS, ECCO2R, lung protective ventilator, lung mechanics
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12F CatheterDevice
Participants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 12 French (12F) catheter
13F CatheterDevice
Participants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 13 French (13F) catheter
15F CatheterDevice
Participants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 15 French (15F) catheter
| Study group | Role | What they receive |
|---|---|---|
| Ultralow-flow extracorporeal carbon dioxide removal system | Experimental | Not described Receives: Device: 12F Catheter; Device: 13F Catheter; Device: 15F Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in PaCO₂ From Baseline
Percentage change in arterial partial pressure of carbon dioxide (PaCO₂) from baseline after initiation of ultra-low-flow ECCO₂R.
Unit of Measure: Percent (%)
Measured: Baseline and 1, 6, 12, 24, 48, and 72 hours after initiation of ECCO₂R.
Secondary outcomes (6)
Percentage of Participants Achieving Correction of Hypercapnic Respiratory Acidosis
Percentage of achievement (% of achievement) in resolving hypercapnic respiratory acidosis (PaCO2 < 50 mmHg and pH>7.30) from hour 0 in acute respiratory distress syndrome (ARDS) patients ventilated using a lung protective strategy with ECCO2R, evaluated for each catheter size at 1, 6, 12, 24, 48, and 72 hours.
Measured: 1, 6, 12, 24, 48, and 72 hours after using a lung protective strategy under ECCO2R
Time to achievement (hours) in resolving hypercapnic respiratory acidosis
Time to achievement (hours) in resolving hypercapnic respiratory acidosis from hour 0 in acute respiratory distress syndrome (ARDS) patients ventilated using a lung protective strategy with ECCO2R, evaluated for each catheter size.
Measured: From using a lung protective strategy under ECCO₂R through 72 hours.
Change in PaO₂/FiO2 ratio From Baseline
Change in PaO₂/FiO2 ratio from baseline following initiation of ECCO₂R.
Measured: 1, 6, 12, 24, 48, and 72 hours.
Circuit Lifespan
Duration of use of the ECCO₂R circuit from initiation until circuit replacement or discontinuation.
Measured: From initiation of ECCO₂R through 72 hours.
Maximum Blood Flow Achieved During ECCO₂R
Maximum blood flow rate achieved during ECCO₂R while maintaining MAP >65 mmHg and protocol-defined circuit pressure safety criteria.
Measured: During the ECCO₂R treatment period, up to 72 hours.
ECCO₂R-Related Complications
Occurrence of complications including catheter-related bleeding, anemia requring blood transfusion, hemolysis, catheter infection, circuit thrombosis, hemodynamic instability, and other patient- or device-related complications.
Measured: From initiation of ECCO₂R through 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858136
- Sponsor's protocol ID
- IRB. No. 0053/68
- Acronym
- Cath-COR
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Catheter Size on the Efficacy of Ultralow-flow Extracorporeal Carbon Dioxide Removal System in Acute Respiratory Distress Syndrome: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07858136
- Acronym / sponsor ID
- Cath-COR / IRB. No. 0053/68
- Keywords
- ARDS, ECCO2R, lung protective ventilator, lung mechanics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 5 Oct 2026 (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 pilot randomized controlled trial will evaluate whether catheter size affects the efficacy and performance of ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) and hypercapnic respiratory acidosis. Participants will be randomly assigned to receive ECCO₂R using a 12F, 13F, or 15F catheter. The primary outcome is the percentage change in PaCO₂ from baseline during ECCO₂R. Secondary outcomes include achievement and time to correction of hypercapnic respiratory acidosis, changes in PaO₂, circuit lifespan, maximum blood flow, and device- and patient-related complications.
Detailed description
Acute respiratory distress syndrome (ARDS) may require lung-protective mechanical ventilation to reduce ventilator-induced lung injury. However, limiting tidal volume, driving pressure, plateau pressure, respiratory rate, and mechanical power may result in hypercapnia and respiratory acidosis in some patients.
Ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) may facilitate carbon dioxide removal while allowing maintenance of a lung-protective or ultra-protective ventilatory strategy. Compared with conventional high-flow extracorporeal carbon dioxide removal, ultra-low-flow ECCO₂R can be performed using smaller vascular catheters.
The efficacy of ultra-low-flow ECCO₂R may be influenced by catheter size because catheter diameter affects vascular resistance and achievable blood flow through the extracorporeal circuit. However, the optimal catheter size for achieving effective carbon dioxide removal while minimizing catheter-related risks remains uncertain.
This study is a prospective, randomized, three-arm pilot study. Adult patients with ARDS and hypercapnic respiratory acidosis who meet predefined criteria despite lung-protective mechanical ventilation will be randomly assigned to receive ultra-low-flow ECCO₂R using a 12F, 13F, or 15F catheter.
Participants will undergo ECCO₂R for a minimum of 72 hours or until predefined criteria for discontinuation are met. Blood flow will initially be set within the protocol-defined range and increased incrementally according to PaCO₂ response and hemodynamic safety parameters.
The study will evaluate the effect of catheter size on carbon dioxide removal, correction of hypercapnic respiratory acidosis, oxygenation, circuit lifespan, maximum blood flow, and patient- and device-related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultralow-flow extracorporeal carbon dioxide removal system | Experimental | Device: 12F Catheter, Device: 13F Catheter, Device: 15F Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Acute respiratory distress syndrome (ARDS), mild to moderate severity, with a PaO₂/FiO₂ ratio of 100-300 while receiving PEEP ≥5 cmH₂O, after initiation of mechanical ventilation within the preceding 72 hours.
- Hypercapnic respiratory acidosis, defined by PaCO₂ >60 mmHg and/or arterial blood gas pH <7.25 due to respiratory acidosis despite mechanical ventilation exceeding the protocol-defined lung-protective strategy, characterized by one or more of the following:
Key exclusion criteria (11 listed)
- Severe shock that is preload non-responsive and requires norepinephrine >1 µg/kg/min.
- Acute brain injury or cerebral edema, increased intracranial pressure, status epilepticus, intracerebral hemorrhage, or acute ischemic stroke.
- Pregnancy.
- Morbid obesity with BMI >40 kg/m².
- Chronic respiratory acidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12F CatheterParticipants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 12 French (12F) catheter | Device | Ultralow-flow extracorporeal carbon dioxide removal system |
| 13F CatheterParticipants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 13 French (13F) catheter | Device | Ultralow-flow extracorporeal carbon dioxide removal system |
| 15F CatheterParticipants randomized to receive ultra-low-flow extracorporeal carbon dioxide removal (ECCO₂R) using a 15 French (15F) catheter | Device | Ultralow-flow extracorporeal carbon dioxide removal system |
Primary outcome
Percentage Change in PaCO₂ From Baseline
Time frame: Baseline and 1, 6, 12, 24, 48, and 72 hours after initiation of ECCO₂R.
Percentage change in arterial partial pressure of carbon dioxide (PaCO₂) from baseline after initiation of ultra-low-flow ECCO₂R. Unit of Measure: Percent (%)
6 secondary outcomes
Percentage of Participants Achieving Correction of Hypercapnic Respiratory Acidosis
Time frame: 1, 6, 12, 24, 48, and 72 hours after using a lung protective strategy under ECCO2R
Time to achievement (hours) in resolving hypercapnic respiratory acidosis
Time frame: From using a lung protective strategy under ECCO₂R through 72 hours.
Change in PaO₂/FiO2 ratio From Baseline
Time frame: 1, 6, 12, 24, 48, and 72 hours.
Circuit Lifespan
Time frame: From initiation of ECCO₂R through 72 hours.
Maximum Blood Flow Achieved During ECCO₂R
Time frame: During the ECCO₂R treatment period, up to 72 hours.
ECCO₂R-Related Complications
Time frame: From initiation of ECCO₂R through 72 hours.
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 8 Oct 2026.
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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?
A study testing 12F Catheter, 13F Catheter and 15F Catheter in people with ARDS (Acute Respiratory Distress Syndrome), run by Chulalongkorn University at 1 site in Thailand.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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 Thailand. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in PaCO₂ From Baseline (time frame: Baseline and 1, 6, 12, 24, 48, and 72 hours after initiation of ECCO₂R.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.