Respiratory Distress Syndrome, AdultU-ProtectNCT02252094
Ultra-protective Pulmonary Ventilation Supported by Low Flow ECCO2R for Severe ARDS
A study testing Prismalung, Ultra-protective ventilation and Conventional Lung Protective Ventilation in people with Respiratory Distress Syndrome, Adult, run by National University Health System, Singapore at 2 sites in Singapore.
Trial summary
This study evaluates the use of ultra-protective ventilation, where very low ventilation volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting criteria to nurse in the prone position. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Prismalung, Ultra-protective ventilation and Conventional Lung Protective Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesSingapore
- Study dates
- 22 May 2017to 31 May 2019
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to MICU with respiratory failure and intubated
- ARDS criteria per Berlin definition
- PaO2:FiO2 ratio ≤ 200 mmHg for > 6 hours with FiO2 ≥0.5
- Expected to require mechanical ventilation for >48 hours
- Reversible disease
Who cannot join
- Anticoagulation contraindicated
- Proven HIT
- Unable to obtain central venous access
- Refractory hypoxia (PaO2:FiO2 ≤80 after recruitment and proning) or other indication for ECMO
- Home oxygen use
- Severe COPD
Show all 10Show fewer
- Interstitial lung disease
- > 7 days of mechanical ventilation
- Immunocompromised patient (bone marrow, untreated HIV, PJP)
- Advanced malignancy with life expectancy ≤ 6months
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital
Singapore, 119074
Ng Teng Fong General Hospital
Singapore, 609606
About this study
Official title: Ultra-protective Pulmonary Ventilation Supported by Low Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) and Prone Positioning for ARDS; a Pilot Study.
This study evaluates the use of ultra-protective ventilation, where very low ventilation volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting criteria to nurse in the prone position. Half the patients will receive ultra-protective ventilation support by extracorporeal carbon dioxide removal, while the other half will receive conventional lung protective ventilation.
Read the detailed description
Current best practices for management of severe ARDS include lung protective ventilation and nursing in the prone position. However, the best lung protective strategy is not currently established and using smaller ventilation volumes than standard lung protective ventilation suggest lung recovery is improved.
Application of smaller ventilation volumes requires extracorporeal carbon dioxide removal, using a device similar to a dialysis to remove carbon dioxide directly from the blood. One such device in the Prismalung, it removes blood through a catheter, much like a dialysis catheter, pumps it through a gas exchange cartridge which removes carbon dioxide. The gas exchange cartridge functions in a similar way to a dialysis filter, except it allow gases to pass through, unlike dialysis filters which allow passage of fluid and small molecules.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Prismalung, Ultra-protective ventilation, Conventional Lung Protective Ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrismalungDevice
Also called Low flow extracorporeal carbon dioxide removal, Respiratory Dialysis
Prism lung (Baxter Healthcare/Gambro Lund, Sweden) is an extracorporeal carbon dioxide removal device. It removes blood through a double lumen catheter and pumps it through a hollow fiber gas exchange cartridge which is impervious to fluid. Carbon dioxide diffuses out, down a concentration gradient which is maintained by sweep gas flowing through the centre of the hollow fibres. The decarboxylated blood is returned to the patient through the double lumen catheter.
Ultra-protective ventilationOther
Ventilation with </= 3ml/kg predicted body weight
Conventional Lung Protective VentilationOther
Ventilation with 6ml/kg predicted body weight
| Study group | Role | What they receive |
|---|---|---|
| Conventional lung protective ventilation | Active comparator | Lung protective ventilation (6ml/kg predicted body weight). All other interventions per intensive care unit standardised ARDS management protocol Receives: Other: Conventional Lung Protective Ventilation |
| Ultra-protective ventilation | Experimental | Ultra-protective ventilation (</= 3ml/kg predicted body weight) targeting plateau pressure of </= 25 cmH2O, supported by Prismalung. All other intervention per intensive care unit standardised ARDS management protocol Receives: Device: Prismalung; Other: Ultra-protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plateau Pressure
Ability to achieve a plateau pressure of </=25 cmH20 in the intervention arm
Measured: Duration of ventilation for severe ARDS, expected average time 10 days
Secondary outcomes (18)
Length of stay in ICU stay
Measured: Duration of patient stay in ICU, expected average stay 2 weeks
Length of hospital stay
Measured: Duration of patient stay in hospital
Mortality
ICU mortality, hospital mortality, 30 day, 60 day and 90 day mortality
Measured: Monitored for 3 months
Cardiac Imaging
Echocardiogram data will be collected before prone position, after prone positioning and following initiation of ultra-protective ventilation
Measured: One data set per patient during first 72 hours
Extracorporeal carbon dioxide removal related complications
Complications or adverse events related to ECCO2R and associated anticoagulation
Measured: Duration of severe ARDS, expected average time frame 10 days
Ventilator free days
Measured: 28 days
All severe adverse events
Measured: Duration of ICU stay (anticipate average stay 1-2 weeks)
Number of patient meeting proning criteria in each group
Measured: Duration of ICU stay
Ability to successfully prone
Measured: Duration of ICU stay
Incidence of dialysis in ICU, and ability to successfully initiate
Measured: Duration of ICU stay
Incidence of referrals for ECMO
Measured: Duration of ICU stay
Rate and reasons for declining consent to study participation
Measured: First 48 hours
Enrolment rates
Measured: First 48 hours
Lung recruitability
Measured: Duration of ICU stay
Ventilation parameters
Data download from mechanical ventilation
Measured: Duration of mechanical ventilation
Ventilator associated pneumonia rates
Measured: Duration of ICU stay
Barotrauma complications
Measured: Duration of ICU stay
Biomarkers of Pulmonary Inflammation
Serum will be drawn and stored for pulmonary biomarkers analysis at the above time points
Measured: Day 0, 4 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start22 May 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Device no longer available in Singapore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Matthew COVE, National University Health System, Singapore
- Investigators
- Matthew E Cove, MBChB, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252094
- Sponsor's protocol ID
- NMRC/TA/0015/2013
- Acronym
- U-Protect
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2014
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
PubMed 19741487Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
PubMed 23306584
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-protective Pulmonary Ventilation Supported by Low Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) and Prone Positioning for ARDS; a Pilot Study.
- ClinicalTrials.gov ID
- NCT02252094
- Acronym / sponsor ID
- U-Protect / NMRC/TA/0015/2013
- Conditions
- Respiratory Distress Syndrome, Adult
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device no longer available in Singapore
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 22 May 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 29 Sep 2014 (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.
This study evaluates the use of ultra-protective ventilation, where very low ventilation volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting criteria to nurse in the prone position. Half the patients will receive ultra-protective ventilation support by extracorporeal carbon dioxide removal, while the other half will receive conventional lung protective ventilation.
Detailed description
Current best practices for management of severe ARDS include lung protective ventilation and nursing in the prone position. However, the best lung protective strategy is not currently established and using smaller ventilation volumes than standard lung protective ventilation suggest lung recovery is improved.
Application of smaller ventilation volumes requires extracorporeal carbon dioxide removal, using a device similar to a dialysis to remove carbon dioxide directly from the blood. One such device in the Prismalung, it removes blood through a catheter, much like a dialysis catheter, pumps it through a gas exchange cartridge which removes carbon dioxide. The gas exchange cartridge functions in a similar way to a dialysis filter, except it allow gases to pass through, unlike dialysis filters which allow passage of fluid and small molecules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional lung protective ventilation | Active comparator | Other: Conventional Lung Protective VentilationLung protective ventilation (6ml/kg predicted body weight). All other interventions per intensive care unit standardised ARDS management protocol |
| Ultra-protective ventilation | Experimental | Device: Prismalung, Other: Ultra-protective ventilationUltra-protective ventilation (</= 3ml/kg predicted body weight) targeting plateau pressure of </= 25 cmH2O, supported by Prismalung. All other intervention per intensive care unit standardised ARDS management protocol |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to MICU with respiratory failure and intubated
- ARDS criteria per Berlin definition
- PaO2:FiO2 ratio ≤ 200 mmHg for > 6 hours with FiO2 ≥0.5
- Expected to require mechanical ventilation for >48 hours
- Reversible disease
Key exclusion criteria (10 listed)
- Anticoagulation contraindicated
- Proven HIT
- Unable to obtain central venous access
- Refractory hypoxia (PaO2:FiO2 ≤80 after recruitment and proning) or other indication for ECMO
- Home oxygen use
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 |
|---|---|---|
| PrismalungAlso: Low flow extracorporeal carbon dioxide removal, Respiratory DialysisPrism lung (Baxter Healthcare/Gambro Lund, Sweden) is an extracorporeal carbon dioxide removal device. It removes blood through a double lumen catheter and pumps it through a hollow fiber gas exchange cartridge which is impervious to fluid. Carbon dioxide diffuses out, down a concentration gradient which is maintained by sweep gas flowing through the centre of the hollow fibres. The decarboxylated blood is returned to the patient through the double lumen catheter. | Device | Ultra-protective ventilation |
| Ultra-protective ventilationVentilation with </= 3ml/kg predicted body weight | Other | Ultra-protective ventilation |
| Conventional Lung Protective VentilationVentilation with 6ml/kg predicted body weight | Other | Conventional lung protective ventilation |
Primary outcome
Plateau Pressure
Time frame: Duration of ventilation for severe ARDS, expected average time 10 days
Ability to achieve a plateau pressure of </=25 cmH20 in the intervention arm
18 secondary outcomes
Length of stay in ICU stay
Time frame: Duration of patient stay in ICU, expected average stay 2 weeks
Length of hospital stay
Time frame: Duration of patient stay in hospital
Mortality
Time frame: Monitored for 3 months
Cardiac Imaging
Time frame: One data set per patient during first 72 hours
Extracorporeal carbon dioxide removal related complications
Time frame: Duration of severe ARDS, expected average time frame 10 days
Ventilator free days
Time frame: 28 days
All severe adverse events
Time frame: Duration of ICU stay (anticipate average stay 1-2 weeks)
Number of patient meeting proning criteria in each group
Time frame: Duration of ICU stay
Ability to successfully prone
Time frame: Duration of ICU stay
Incidence of dialysis in ICU, and ability to successfully initiate
Time frame: Duration of ICU stay
Incidence of referrals for ECMO
Time frame: Duration of ICU stay
Rate and reasons for declining consent to study participation
Time frame: First 48 hours
Enrolment rates
Time frame: First 48 hours
Lung recruitability
Time frame: Duration of ICU stay
Ventilation parameters
Time frame: Duration of mechanical ventilation
Ventilator associated pneumonia rates
Time frame: Duration of ICU stay
Barotrauma complications
Time frame: Duration of ICU stay
Biomarkers of Pulmonary Inflammation
Time frame: Day 0, 4 and 7
Results and safety
The study was stopped early (reason given: Device no longer available in Singapore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Background: PubMed 19741487Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
- Background: PubMed 23306584Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
- 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. This study is not recruiting at the moment.
Matthew E Cove, MBChB principal investigator
National University Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prismalung, Ultra-protective ventilation and Conventional Lung Protective Ventilation in people with Respiratory Distress Syndrome, Adult, run by National University Health System, Singapore at 2 sites in Singapore.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 was stopped early (reason given: Device no longer available in Singapore). Results are not available in the source record.
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?
Plateau Pressure (time frame: Duration of ventilation for severe ARDS, expected average time 10 days). 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 NCT02252094, which also lists 2 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 14 Sep 2020; AzTrials last refreshed its copy on 26 Oct 2026.