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

Respiratory Distress Syndrome Clinical Trial

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

Status Not yet recruiting

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.

Clinical Trial 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 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

• NCT number: NCT01774422
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin@chu-clermontferrand.fr
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2013
• Completion date: January 2015