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

January 21, 2013 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: noninvasive ventilation alone

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
Device: Extracorporeal CO2 removal device
Other: noninvasive ventilation associated with the DECAP CO2 device

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
Device: Extracorporeal CO2 removal device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hypercapnia
Time Frame: H24
H24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Blood gases
Time Frame: H0
H0
Duration of judgment disability
Time Frame: H72
H72
Duration of blood pH normalization
Time Frame: H72
H72
Duration of hypercapnia
Time Frame: H72
H72
Glasgow
Time Frame: H0
H0
SAPSII scores(Simplified Acute Physiology Score II)
Time Frame: H24
H24
Duration of noninvasive ventilation
Time Frame: H72
H72
Duration of hospitalization
Time Frame: H72
H72
Mortality
Time Frame: H72
H72
MMSE (Mini Mental State Examination)
Time Frame: H0
H0
ACE ( Aid To Capacity Evaluation)scores
Time Frame: H0
H0
SOFA scores(Sepsis-related Organ )
Time Frame: H24
H24
Blood gases
Time Frame: H1
H1
Blood gases
Time Frame: H2
H2
Blood gases
Time Frame: H3
H3
Blood gases
Time Frame: H4
H4
Blood gases
Time Frame: H6
H6
Blood gases
Time Frame: H12
H12
Blood gases
Time Frame: H18
H18
Blood Gases
Time Frame: H24
H24
Blood gases
Time Frame: H32
H32
Blood gases
Time Frame: H40
H40
Blood gases
Time Frame: H48
H48
Blood gases
Time Frame: H56
H56
Blood gases
Time Frame: H64
H64
Blood gases
Time Frame: H72
H72
Glasgow
Time Frame: H4
H4
Glasgow
Time Frame: H8
H8
Glasgow
Time Frame: H24
H24
Glasgow
Time Frame: H36
H36
Glasgow
Time Frame: H48
H48
MMSE (Mini Mental State Examination)
Time Frame: H4
H4
MMSE (Mini Mental State Examination)
Time Frame: H8
H8
MMSE (Mini Mental State Examination)
Time Frame: H24
H24
MMSE (Mini Mental State Examination)
Time Frame: H36
H36
MMSE (Mini Mental State Examination)
Time Frame: H48
H48
ACE ( Aid To Capacity Evaluation)scores
Time Frame: H4
H4
ACE ( Aid To Capacity Evaluation)scores
Time Frame: H8
H8
ACE ( Aid To Capacity Evaluation)scores
Time Frame: H24
H24
ACE ( Aid To Capacity Evaluation)scores
Time Frame: H36
H36
ACE ( Aid To Capacity Evaluation)scores
Time Frame: H48
H48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandre Lautrette, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHU-0136
  • 2012-A01159-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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