Diaphragmatic Pacer Placement: Anesthetic Management (DP)

NCT02942953 | Completed

• 1 other identifier: 2015209
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries; Amyotrophic Lateral Sclerosis; Respiratory Paralysis

Keywords

Pacemaker, Artificial; Diaphragmatic pacing

Outcome Measures

Primary Outcomes (1)

• all cause of morbidity

  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

  two weeks

Secondary Outcomes (1)

• anesthetic technique

  surgery time

Study Arms (1)

Diaphragmatic Pacer

Patient that have been proposed to diaphragmatic pacer placement at our institution.

Device: Diaphragmatic Pacer

Interventions

Diaphragmatic Pacer DEVICE

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.

Also known as: NeuRx® Diaphragm Pacing Stimulation System

Diaphragmatic Pacer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients conducted to diaphragmatic pacer placement from December 2007 to July 2015 at our institution

You may qualify if:

• diaphragmatic pacer placement surgery

You may not qualify if:

• no access to patients history

Sponsors & Collaborators

• Institut Guttmann: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Amyotrophic Lateral Sclerosis; Respiratory Paralysis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• nuria alegret, MD

  Anesthesiogist at Guttmann Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: October 24, 2016
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 24, 2016

Record last verified: 2016-10