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

This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01774422
First received: January 7, 2013
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome
Hypercapnia
 Device: Extracorporeal CO2 removal device
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Hypercapnia [ Time Frame: H24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood gases [ Time Frame: H0 ] [ Designated as safety issue: Yes ]
  • Duration of judgment disability [ Time Frame: H72 ] [ Designated as safety issue: Yes ]
  • Duration of blood pH normalization [ Time Frame: H72 ] [ Designated as safety issue: Yes ]
  • Duration of hypercapnia [ Time Frame: H72 ] [ Designated as safety issue: Yes ]
  • Glasgow [ Time Frame: H0 ] [ Designated as safety issue: Yes ]
  • SAPSII scores(Simplified Acute Physiology Score II) [ Time Frame: H24 ] [ Designated as safety issue: Yes ]
  • Duration of noninvasive ventilation [ Time Frame: H72 ] [ Designated as safety issue: Yes ]
  • Duration of hospitalization [ Time Frame: H72 ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: H72 ] [ Designated as safety issue: Yes ]
  • MMSE (Mini Mental State Examination) [ Time Frame: H0 ] [ Designated as safety issue: Yes ]
  • ACE ( Aid To Capacity Evaluation)scores [ Time Frame: H0 ] [ Designated as safety issue: Yes ]
  • SOFA scores(Sepsis-related Organ ) [ Time Frame: H24 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H1 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H2 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H3 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H4 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H6 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H12 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H18 ] [ Designated as safety issue: Yes ]
  • Blood Gases [ Time Frame: H24 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H32 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H40 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H48 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H56 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H64 ] [ Designated as safety issue: Yes ]
  • Blood gases [ Time Frame: H72 ] [ Designated as safety issue: Yes ]
  • Glasgow [ Time Frame: H4 ] [ Designated as safety issue: Yes ]
  • Glasgow [ Time Frame: H8 ] [ Designated as safety issue: Yes ]
  • Glasgow [ Time Frame: H24 ] [ Designated as safety issue: Yes ]
  • Glasgow [ Time Frame: H36 ] [ Designated as safety issue: Yes ]
  • Glasgow [ Time Frame: H48 ] [ Designated as safety issue: Yes ]
  • MMSE (Mini Mental State Examination) [ Time Frame: H4 ] [ Designated as safety issue: Yes ]
  • MMSE (Mini Mental State Examination) [ Time Frame: H8 ] [ Designated as safety issue: Yes ]
  • MMSE (Mini Mental State Examination) [ Time Frame: H24 ] [ Designated as safety issue: Yes ]
  • MMSE (Mini Mental State Examination) [ Time Frame: H36 ] [ Designated as safety issue: Yes ]
  • MMSE (Mini Mental State Examination) [ Time Frame: H48 ] [ Designated as safety issue: Yes ]
  • ACE ( Aid To Capacity Evaluation)scores [ Time Frame: H4 ] [ Designated as safety issue: Yes ]
  • ACE ( Aid To Capacity Evaluation)scores [ Time Frame: H8 ] [ Designated as safety issue: Yes ]
  • ACE ( Aid To Capacity Evaluation)scores [ Time Frame: H24 ] [ Designated as safety issue: Yes ]
  • ACE ( Aid To Capacity Evaluation)scores [ Time Frame: H36 ] [ Designated as safety issue: Yes ]
  • ACE ( Aid To Capacity Evaluation)scores [ Time Frame: H48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774422

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Alexandre LAUTRETTE University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01774422     History of Changes
Other Study ID Numbers: CHU-0136, 2012-A01159-34
Study First Received: January 7, 2013
Last Updated: January 21, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Hypercapnia
Respiratory Distress Syndrome
Extracorporeal CO2 remover
Noninvasive ventilation

Additional relevant MeSH terms:
Hypercapnia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Signs and Symptoms, Respiratory
Signs and Symptoms
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on June 18, 2013