ARDS (Acute Respiratory Distress Syndrome)NCT01913977

Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System

A study testing Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min, Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min and Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min in people with ARDS (Acute Respiratory Distress Syndrome) and Respiratory Acidosis, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This prospective study includes 5 patients with ARDS (Acute Respiratory Distress Syndrome) treated by mechanical ventilation. In case of respiratory acidosis, extracorporeal CO2 (carbon dioxide)removal might be necessary. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ARDS (Acute Respiratory Distress Syndrome), Respiratory Acidosis
What is being tested?: Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min, Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min and Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteBelgium
Study dates: 20 Feb 2014to 12 Sep 2014
Phase: Interventional
Are there results?: None posted in the registry

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

Patients with ARDS and respiratory acidosis on the intensive care unit
Treated with the Abylcap system (Bellco, Italy)
Not pregnant

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

About this study

Official title: Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System.

The patients (M/V) are older than 18, not pregnant, have a BMI<30, and no contraindication for anticoagulation therapy.

Under standard conditions patients are treated with a blood flow of QB=300mL/min and a gas flow (100% 02) of QG=7L/min. Blood sampling is performed from the arterial bloodline in the patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h.

A parameter study is also performed to optimise CO2 removal. Herewith, blood samples (1mL) are taken from the inlet and outlet line of the Lilliput2 at the previously mentioned time points and for different flow setting: Blood flow (QB) 200-300-400mL/min and gas flow (QG) 1.5, 3, 6, 7, 8L/min

Blood samples are analysed for the different blood gases from which the extraction in the CO2 remover can be calculated for each setting of QB (blood flow) and QG (gas flow).

Conditions: ARDS (Acute Respiratory Distress Syndrome), Respiratory Acidosis
Being tested: Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min, Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min, Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min, Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min, Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min
Medical subject headings: Acute Lung Injury, Acidosis, Respiratory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/minDevice
Abylcap settings
Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/minDevice
Abylcap settings
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/minDevice
Abylcap settings
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/minDevice
Abylcap settings
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/minDevice
Abylcap settings
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/minDevice
Abylcap settings
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/minDevice
Abylcap settings

Study groups in NCT01913977
Study group	Role	What they receive
Treatment with mechanical ventilation	Experimental	Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy). Receives: Device: Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min; Device: Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min; Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min

What is being measured

The primary outcome is the main question the study is designed to answer.

calculation of CO2 extraction in blood samples during mechanical ventilation
Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover.
Measured: during mechanical ventilation with CO2 removal (max up to 120h)

Secondary outcomes (1)

Based on the extraction rates, the optimum parameter settings are derived
Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover.
Measured: During mechanical ventilation with CO2 removal (max up to 120h)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201412 Sep 2014

First posted1 Aug 2013 (estimated)
Study start20 Feb 2014
Primary completion13 Jun 2014
Study completion12 Sep 2014

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.
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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01913977
Sponsor's protocol ID: 2013/386
Status last verified: Dec 2022
First submitted: 6 Jun 2013
Last updated: 29 Dec 2022
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
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Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
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RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingObservational study
Right Heart Injury Monitoring on ECMO
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All ARDS (Acute Respiratory Distress Syndrome) trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System.
ClinicalTrials.gov ID: NCT01913977
Acronym / sponsor ID: 2013/386
Conditions: ARDS (Acute Respiratory Distress Syndrome), Respiratory Acidosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Study start: 20 Feb 2014 (actual)
Primary completion: 13 Jun 2014 (actual)
Study completion: 12 Sep 2014 (actual)
First posted: 1 Aug 2013 (estimated)
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.

The patients (M/V) are older than 18, not pregnant, have a BMI<30, and no contraindication for anticoagulation therapy.

Blood samples are analysed for the different blood gases from which the extraction in the CO2 remover can be calculated for each setting of QB (blood flow) and QG (gas flow).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment with mechanical ventilation	Experimental	Device: Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min, Device: Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min, Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min, Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min, Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min, Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min, Device: Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/minAbylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with ARDS and respiratory acidosis on the intensive care unit
Treated with the Abylcap system (Bellco, Italy)
Not pregnant

Key exclusion criteria (0 listed)

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
Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/minAbylcap settings	Device	Treatment with mechanical ventilation
Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/minAbylcap settings	Device	Treatment with mechanical ventilation
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/minAbylcap settings	Device	Treatment with mechanical ventilation
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/minAbylcap settings	Device	Treatment with mechanical ventilation
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/minAbylcap settings	Device	Treatment with mechanical ventilation
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/minAbylcap settings	Device	Treatment with mechanical ventilation
Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/minAbylcap settings	Device	Treatment with mechanical ventilation

Primary outcome

calculation of CO2 extraction in blood samples during mechanical ventilation
Time frame: during mechanical ventilation with CO2 removal (max up to 120h)
Extraction is calculated from the relative difference in blood gases at the inlet and outlet of the CO2 remover.

1 secondary outcome

Based on the extraction rates, the optimum parameter settings are derived
Time frame: During mechanical ventilation with CO2 removal (max up to 120h)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.

Related trials for ARDS (Acute Respiratory Distress Syndrome)

Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
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RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
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Not yet recruitingObservational study
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Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF)

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. This study is not recruiting at the moment.

Sunny Eloot, PhD, MScBME, MScCivE principal investigator

University Hospital, Ghent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 0 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: finished, as of the sponsor's last update on 29 Dec 2022. 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 Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

calculation of CO2 extraction in blood samples during mechanical ventilation (time frame: during mechanical ventilation with CO2 removal (max up to 120h)). 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 NCT01913977.

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 29 Dec 2022.