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

Phase 2

• Conditions: Respiratory Distress Syndrome; Hypercapnia
• Interventions: Device: Extracorporeal CO2 removal device

• Registration Number: NCT01774422
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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. 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.

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 Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-21
• Last Update Submitted: 2013-01-21
• Study First Posted: 2013-01-24
• Last Update Posted: 2013-01-24
• Primary Completion: 2015-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
noninvasive ventilation associated with the DECAP CO2 device	Extracorporeal CO2 removal 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
noninvasive ventilation alone	Extracorporeal CO2 removal 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

Primary Outcome Measures

Name	Time	Method
Hypercapnia	H24

Secondary Outcome Measures

Name	Time	Method
Blood gases	H72
Duration of judgment disability	H72
Duration of blood pH normalization	H72
Duration of hypercapnia	H72
Glasgow	H48
SAPSII scores(Simplified Acute Physiology Score II)	H24
Duration of noninvasive ventilation	H72
Duration of hospitalization	H72
Mortality	H72
MMSE (Mini Mental State Examination)	H48
ACE ( Aid To Capacity Evaluation)scores	H48
SOFA scores(Sepsis-related Organ )	H24
Blood Gases	H24