New Intramuscular Electrodes for Respiratory Pacing in SCI

描述(由申请人提供)： 完全性颈髓损伤(SCI)通常需要呼吸机支持。作为机械通风的替代方法，在隔膜内植入电极刺激膈神经正逐渐被人们所接受。然而，有必要改善隔膜刺激，并增加腹部和上胸肋间肌肉刺激，以改善呼吸和咳嗽。我们将为这些应用测试一种新的电极：PerMalocTM双极多触点(P-BMC)电极(Synapse Biomedical Inc.)。通过使用大电流呼吸刺激器和两相刺激波形，新电极的呼吸反应也将得到增强。 在这项为期一年的研究中，将对一组12只急性犬进行研究。呼吸起搏研究 随后的麻醉将在过度换气后的呼吸暂停期间进行。 在每种动物身上，方案将遵循研究目的的顺序。气管压力将是主要的衡量标准，而呼吸道流量也将是主要的衡量标准。对于咳嗽和20分钟的起搏试验，空气流量将是主要的测量方法。额外的呼吸措施将包括食道和腹部压力。气囊的记录将提供上胸和腹部肌肉扩张和收缩的定性测量，以便在气流研究期间进行记录。肌肉对刺激的收缩反应也将根据观察和触诊进行评级。模拟测试方法将包括随机顺序分配的重复测试。所有数据将以平均值扫描电子显微镜的形式显示。统计分析将通过方差分析和使用学生-诺伊曼-科尔斯检验进行的事后比较进行。本研究的结果有望为颈椎水平脊髓损伤患者的新型电极的技术转移做出贡献。 公共卫生相关性： 呼吸问题仍然是高位颈髓损伤(SCI)患者的主要担忧，死亡最常归因于肺炎，通常需要呼吸机支持。作为机械通风的替代方法，在隔膜内植入电极刺激膈神经正逐渐被人们所接受。然而，有必要改善隔膜刺激，并增加腹部和上胸肋间肌肉刺激，以改善呼吸和咳嗽。我们将在动物模型中测试一种用于这些应用的新电极--PermalocTM双极多触点(P-BMC；Synapse Biomedical Inc.)。通过使用大电流呼吸刺激器和双相刺激波形，P-BMC的呼吸反应也将得到增强。本研究的结果有望为颈椎水平脊髓损伤患者新型电极的技术转移做出贡献。 呼吸系统护理，包括退伍军人管理局SCI患者。

DESCRIPTION (provided by applicant): Complete cervical spinal cord injury (SCI) usually requires ventilator support. As an alternative to mechanical ventilation, stimulation of the phrenic nerve with electrodes implanted in the diaphragm is gaining acceptance. There is a need, however, to improve diaphragm stimulation and to add abdominal and upper thorax intercostal muscle stimulation for improved respiration and cough. We will test a new electrode for these applications: the PermalocTM bipolar multi-contact (P-BMC) electrode (Synapse Biomedical Inc). Respiratory responses with the new electrode will also be enhanced by using a high current respiratory stimulator and a biphasic stimulating wave form. One group of 12 acute dogs will be studied during this 1-YR investigation. Respiratory pacing studies following anesthesia will be conducted during periods of respiratory apnea following hyperventilation. Protocols will follow the order of the Aims of the study in each animal. Tracheal pressure will be the primary measure whereas airway flow will also be a primary measure. For cough and 20 min pacing tests airflow will be the primary measure. Additional respiratory measures will include esophageal and abdominal pressures. The recording of pneumobelts will provide a qualitative measure of upper-chest and abdominal muscle expansion and contractions to be recorded during airflow studies. Muscle contractile responses to stimulation will also be rated based on observation and palpation. Stimulation testing methods will include duplicate tests with random order assignment. All data will be presented as Mean + SEM. Statistical analysis will be done by ANOVA with post hoc comparisons made using the Student-Neuman-Keuls test. Results of this study are expected to contribute to technology transfer of the new electrode for cervical-level SCI patients. PUBLIC HEALTH RELEVANCE: Respiratory problems continue to be a primary concern for individuals with upper-level cervical spinal cord injury (SCI) with mortality most often attributed to pneumonia and usually requires ventilator support. As an alternative to mechanical ventilation, stimulation of the phrenic nerve with electrodes implanted in the diaphragm is gaining acceptance. There is a need, however, to improve diaphragm stimulation and to add abdominal and upper thorax intercostal muscle stimulation for improved respiration and cough. We will test a new electrode for these applications, the PermalocTM bipolar multi-contact (P-BMC; Synapse Biomedical Inc) in an animal model. Respiratory responses with the P-BMC will also be enhanced by using a high current respiratory stimulator and a biphasic stimulating wave form. Results of this study are expected to contribute to technology transfer of the new electrode for cervical-level SCI patient's respiratory care including Veterans Administration SCI patients.