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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT01774422
Date of registration:	07/01/2013
Prospective Registration:	No
Primary sponsor:	University Hospital, Clermont-Ferrand
Public title:	Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation DECAP CO2
Scientific title:	Use of the Medical Device DECAP CO2 for the Treatment of Hypercapnic Respiratory Distress in Patients Under Noninvasive Ventilation
Date of first enrolment:	January 2013
Target sample size:	32
Recruitment status:	Not yet recruiting
URL:	http://clinicaltrials.gov/show/NCT01774422
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	Phase 2

Countries of recruitment

Contacts

Name:	Patrick LACARIN
Address:
Telephone:	04 73 75 11 95
Email:	placarin@chu-clermontferrand.fr
Affiliation:

Name:	Alexandre LAUTRETTE
Address:
Telephone:
Email:
Affiliation:	University Hospital, Clermont-Ferrand

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypercapnia

Respiratory Distress Syndrome

Intervention(s)

Device: Extracorporeal CO2 removal device

Primary Outcome(s)

Hypercapnia [Time Frame: H24]

Secondary Outcome(s)

Blood gases [Time Frame: H32]

Blood gases [Time Frame: H48]

MMSE (Mini Mental State Examination) [Time Frame: H8]

ACE ( Aid To Capacity Evaluation)scores [Time Frame: H0]

ACE ( Aid To Capacity Evaluation)scores [Time Frame: H4]

Blood gases [Time Frame: H40]

Blood gases [Time Frame: H72]

Duration of blood pH normalization [Time Frame: H72]

ACE ( Aid To Capacity Evaluation)scores [Time Frame: H8]

Blood gases [Time Frame: H0]

ACE ( Aid To Capacity Evaluation)scores [Time Frame: H24]

Blood gases [Time Frame: H18]

Blood gases [Time Frame: H56]

Duration of hypercapnia [Time Frame: H72]

Duration of judgment disability [Time Frame: H72]

Blood gases [Time Frame: H1]

Blood Gases [Time Frame: H24]

Blood gases [Time Frame: H6]

Duration of noninvasive ventilation [Time Frame: H72]

Glasgow [Time Frame: H8]

ACE ( Aid To Capacity Evaluation)scores [Time Frame: H36]

Glasgow [Time Frame: H48]

MMSE (Mini Mental State Examination) [Time Frame: H24]

MMSE (Mini Mental State Examination) [Time Frame: H4]

Glasgow [Time Frame: H24]

Mortality [Time Frame: H72]

Blood gases [Time Frame: H3]

Duration of hospitalization [Time Frame: H72]

MMSE (Mini Mental State Examination) [Time Frame: H0]

MMSE (Mini Mental State Examination) [Time Frame: H48]

SAPSII scores(Simplified Acute Physiology Score II) [Time Frame: H24]

MMSE (Mini Mental State Examination) [Time Frame: H36]

Blood gases [Time Frame: H12]

Glasgow [Time Frame: H36]

ACE ( Aid To Capacity Evaluation)scores [Time Frame: H48]

Blood gases [Time Frame: H2]

Blood gases [Time Frame: H4]

Blood gases [Time Frame: H64]

Glasgow [Time Frame: H0]

Glasgow [Time Frame: H4]

SOFA scores(Sepsis-related Organ ) [Time Frame: H24]

Secondary ID(s)

2012-A01159-34

CHU-0136

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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