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

Respiratory Distress Syndrome Clinical Trial

— DECAP CO2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01774422
• Other study ID #: CHU-0136
• Secondary ID: 2012-A01159-34
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 7, 2013
• Last updated: January 21, 2013
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercapnia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Extracorporeal CO2 removal device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Outcome

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