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

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: Unknown
• Conditions: Respiratory Distress Syndrome; Hypercapnia
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Hypercapnia	H24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Alexandre LAUTRETTE, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: January 7, 2013
• First Submitted That Met QC Criteria: January 21, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 21, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Hypercapnia; Noninvasive ventilation; Respiratory Distress Syndrome; Extracorporeal CO2 remover
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hypercapnia
• Other Study ID Numbers: CHU-0136; 2012-A01159-34