Diaphragmatic Pacer Placement: Anesthetic Management (DP)

CompletedOBSERVATIONAL
Enrollment

16

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Spinal Cord InjuriesAmyotrophic Lateral SclerosisRespiratory Paralysis
Interventions
DEVICE

Diaphragmatic Pacer

The surgical procedure of DP implantation consists in placing four intramuscular electrodes, using a conventional abdominal laparoscopy with four ports. It consists in locating the optimum point for electrode insertion. The process involves mapping between 30 and 50 different points in each hemidiaphragm by applying an electric stimulus of 2-24 mA at 100 µsec pulse widths11. It results in both qualitative and quantitative assessment of diaphragmatic movement. Site of main electrode is identified as the location of each hemidiaphragm's change of maximum pressure and site of secondary electrode as replica of main site. Once the sites are identified intramuscular electrode placement phase is initiated. Finally the electrodes are tunneled out to the corresponding percutaneous exit site.

All Listed Sponsors
lead

Institut Guttmann

OTHER

NCT02942953 - Diaphragmatic Pacer Placement: Anesthetic Management (DP) | Biotech Hunter | Biotech Hunter