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Respiratory Distress SyndromePhase 2DECAP CO2NCT01774422

Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation

A Phase 2 study testing Extracorporeal CO2 removal device in people with Respiratory Distress Syndrome and Hypercapnia, run by University Hospital, Clermont-Ferrand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The patients affected by severe chronic respiratory failure can develop hypercapnic decompensation leading to coma and death in a few hours. At present, the main treatment is noninvasive or invasive ventilation. The noninvasive invasive ventilation requires a minimum of consciousness to insure spontaneous ventilation. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Respiratory Distress Syndrome, Hypercapnia
What is being tested?
Extracorporeal CO2 removal device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
Jan 2013to Jan 2015
Phase
Phase 2
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient suffering from severe chronic respiratory failure
  • Chronic obstructive pulmonary disease : stage III
  • Hypercapnic respiratory decomposition
  • No anticipated directive with the treating physician, pulmonologist or his family.
  • Challenged for invasive ventilation by critical care doctor, emergency doctor or pulmonologist ; due to the respiratory pathology severity or other (age, comorbidity)
  • Not challenged for a noninvasive ventilation
  • Failure of the noninvasive ventilation in intensive care unit (pH decrease due to hypercapnia after 2 hours of noninvasive ventilation
  • Obtaining of the consent of the patient or the reliable person or the close relation

Who cannot join

  • - Patients who made anticipated directives (decision of the patient to have no tracheotomy, intubation, noninvasive ventilation)
  • Contraindication to heparin (active bleeding, Heparin-induced thrombocytopenia)
  • Patients < 18 years and > 90 years
  • Patients already included in another therapeutic trial
  • Pregnant woman or breast feeding
  • Legal incapacity

Trial locations and contacts

No sites are listed yet.

Patrick LACARIN contact

04 73 75 11 95

placarin@chu-clermontferrand.fr

About this study

The patients affected by severe chronic respiratory failure can develop hypercapnic decompensation leading to coma and death in a few hours. At present, the main treatment is noninvasive or invasive ventilation. The noninvasive invasive ventilation requires a minimum of consciousness to insure spontaneous ventilation. In case of noninvasive ventilation impossibility, invasive mechanical ventilation is proposed to patients, which is an aggressive therapy. Regularly, the patients undergo this aggressive therapy without having expressed their opinion. Indeed, a great majority of these patients with severe respiratory insufficiency did not anticipate directives in case of respiratory decompensation (acceptation of aggressive treatments). Efficiency of these aggressive therapies is still uncertain but certainly alters quality of life (discomfort, loss of autonomy…). After complete, clear, loyal and adapted information, a majority of patient do not wish to go on these aggressive therapies. At the time of the decompensation, the patients are incapable to express an opinion because of the hypercapnic narcosis. An extracorporeal CO2 remover device, such as the DECAP CO2, would quickly decrease the hypercapnia what would allow the patient to improve his state of consciousness and so to find the conditions of spontaneous ventilation required for the noninvasive ventilation. The DECAP CO2 device can be used to stop quickly the hypercapnic narcosis and to collect the wills of the patient on the choice of possible aggressive therapies. It is in this last condition that we wish to estimate the DECAP CO2 device.

Read the detailed description

After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study:

  • Noninvasive ventilation alone
  • Noninvasive ventilation associated with the DECAP CO2 device
Being tested
Extracorporeal CO2 removal device
Keywords
Hypercapnia, Respiratory Distress Syndrome, Extracorporeal CO2 remover, Noninvasive ventilation
Medical subject headings
Respiratory Distress Syndrome, Hypercapnia

What participants receive

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

  • Extracorporeal CO2 removal deviceDevice

Study groups in NCT01774422
Study groupRoleWhat they receive
noninvasive ventilation aloneExperimentalAfter validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: * Noninvasive ventilation alone * Noninvasive ventilation associated with the DECAP CO2 device
Receives: Device: Extracorporeal CO2 removal device
noninvasive ventilation associated with the DECAP CO2 deviceOtherAfter validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: * Noninvasive ventilation alone * Noninvasive ventilation associated with the DECAP CO2 device
Receives: Device: Extracorporeal CO2 removal device

What is being measured

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

  1. Hypercapnia

    Measured: H24

Secondary outcomes (41)

  1. Blood gases

    Measured: H0

  2. Duration of judgment disability

    Measured: H72

  3. Duration of blood pH normalization

    Measured: H72

  4. Duration of hypercapnia

    Measured: H72

  5. Glasgow

    Measured: H0

  6. SAPSII scores(Simplified Acute Physiology Score II)

    Measured: H24

  7. Duration of noninvasive ventilation

    Measured: H72

  8. Duration of hospitalization

    Measured: H72

  9. Mortality

    Measured: H72

  10. MMSE (Mini Mental State Examination)

    Measured: H0

  11. ACE ( Aid To Capacity Evaluation)scores

    Measured: H0

  12. SOFA scores(Sepsis-related Organ )

    Measured: H24

  13. Blood gases

    Measured: H1

  14. Blood gases

    Measured: H2

  15. Blood gases

    Measured: H3

  16. Blood gases

    Measured: H4

  17. Blood gases

    Measured: H6

  18. Blood gases

    Measured: H12

  19. Blood gases

    Measured: H18

  20. Blood Gases

    Measured: H24

  21. Blood gases

    Measured: H32

  22. Blood gases

    Measured: H40

  23. Blood gases

    Measured: H48

  24. Blood gases

    Measured: H56

  25. Blood gases

    Measured: H64

  26. Blood gases

    Measured: H72

  27. Glasgow

    Measured: H4

  28. Glasgow

    Measured: H8

  29. Glasgow

    Measured: H24

  30. Glasgow

    Measured: H36

  31. Glasgow

    Measured: H48

  32. MMSE (Mini Mental State Examination)

    Measured: H4

  33. MMSE (Mini Mental State Examination)

    Measured: H8

  34. MMSE (Mini Mental State Examination)

    Measured: H24

  35. MMSE (Mini Mental State Examination)

    Measured: H36

  36. MMSE (Mini Mental State Examination)

    Measured: H48

  37. ACE ( Aid To Capacity Evaluation)scores

    Measured: H4

  38. ACE ( Aid To Capacity Evaluation)scores

    Measured: H8

  39. ACE ( Aid To Capacity Evaluation)scores

    Measured: H24

  40. ACE ( Aid To Capacity Evaluation)scores

    Measured: H36

  41. ACE ( Aid To Capacity Evaluation)scores

    Measured: H48

Timeline

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

  1. First posted24 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2015 (estimated)
  4. Study completionJan 2015 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01774422
Sponsor's protocol ID
CHU-0136
Other IDs
2012-A01159-34
Acronym
DECAP CO2
Status last verified
Jan 2013
First submitted
7 Jan 2013
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Extracorporeal CO2 removal device in people with Respiratory Distress Syndrome and Hypercapnia, run by University Hospital, Clermont-Ferrand.

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 6 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: status not confirmed, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypercapnia (time frame: H24). 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 NCT01774422.

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 24 Jan 2013.

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