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Diaphragmatic Pacer Placement: Anesthetic Management (DP)

NCT02942953 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2016-10-24

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Institut Guttmann

    lead OTHER

Principal Investigators

  • nuria alegret, MD · Anesthesiogist at Guttmann Institute

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02942953 on ClinicalTrials.gov