Clinical Trial: Diaphragmatic Pacer Placement: Anesthetic Management (DP)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: Diaphragmatic Pacer Placement: Anesthetic Management (DP)

Brief Summary: The diaphragmatic pacemaker (DP) has proven its utility in replacing mechanical ventilation (MV) in patients with chronic spinal cord injury (SCI) and Amyotrophic Lateral Sclerosis (ALS), by improving the patients quality of life and reducing morbi-mortality and the associated health care costs. The anesthetic management of these patients and the particularities of the surgical procedure represent an anesthetic challenge. The objective of our study is to analyze the management and the intraoperative complications in the patients with DP in our institution.

Detailed Summary:

Patients included are part of a program developed by the Spinal Cord Injury Unit of the Institut Guttmann of placement and strengthening of the diaphragm with NeuRx® Diaphragm Pacing Stimulation (DPS) System (Synapse Biomedical, Oberlin, OH, USA) device for patients suffering from neuromuscular disorders or upper spinal cord injuries dependent on MV. All of them were preselected by a multidisciplinary expert committee after the assessment of their clinical history and the evaluation of the phrenic nerve function using two complementary techniques like phrenic nerve stimulation and fluoroscopic evaluation of diaphragm movement. Pediatric patients were the exception, since they underwent surgery in order to obtain a definitive diagnosis on the phrenic nerve functionality. Patients were admitted in the center 24 hours prior to the intervention.

The surgical procedure of DP implantation consists in placing four intramuscular electrodes, two in each hemidiaphragm, using a conventional abdominal laparoscopy with carbon dioxide insufflation at 10 L/minute speed and pressure up to 15 mmHg. Four ports are inserted: one for the optical equipment, two for the mapping electrode and electrode insertion instruments and a smaller sized port as an exit site for the wires of the electrodes. Reverse Trendelenburg position is required for the procedure. 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: qualitative through laparoscopy and quantitative using the external assessment of the intraabdominal pressure during stimulation with temporal mapping electrode. Site of main electrode is identified as the location of each hem
Sponsor: Institut Guttmann

Current Primary Outcome: all cause of morbidity [ Time Frame: two weeks ]

evidence of morbity associated DP surgery: pnemothorax assessed by RX, capnothorax assessed by mecanical ventilation dificulties during surgery, arrythmia during surgery, automomic dysreflexia defined as hipertensive crisis associated to painful stimuly during surgery


Original Primary Outcome: Same as current

Current Secondary Outcome: anesthetic technique [ Time Frame: surgery time ]

anesthetic technique used for the surgery: total intravenous anesthesia or balanced anesthesia


Original Secondary Outcome: Same as current

Information By: Institut Guttmann

Dates:
Date Received: July 13, 2016
Date Started: June 2015
Date Completion:
Last Updated: October 21, 2016
Last Verified: October 2016