Bentley Ishmael, Jocewicz Frank T, Johnson Bruce D, Mehta Hitesh P
Stimdia Medical Inc., Mendota Heights, MN, United States.
Mayo Clinic, Rochester, MN, United States.
Front Physiol. 2024 Jul 1;15:1397070. doi: 10.3389/fphys.2024.1397070. eCollection 2024.
Phrenic nerve stimulation is currently being investigated for the prevention of diaphragm atrophy in patients with mechanically supported breathing. Patients receiving breathing support from mechanical ventilation are at risk of mismatches between respiratory demand and ventilator support. Our objectives were to determine if a novel phrenic nerve stimulation device provided stimulation during inspiration as intended and did not exacerbate any potential discordances. A benchtop electromechanical simulation model was developed to validate phrenic nerve stimulation with simulated breathing. The phrenic nerve stimulation device was evaluated with a mechanical ventilator attached to a breathing simulator. The trigger ratio and time lag between phrenic nerve stimulation and mechanical ventilation was measured for multiple disease and ventilator parameters. For the 1:1 breath trigger ratio test, 99.79% of intended stimulation breaths received stimulation at the correct time. For the 1:4 breath trigger ratio test, 99.72% of intended stimulation breaths received stimulation at the correct time. For trigger lag times for the inspiratory and expiratory phases, the mean inspiratory lag was 36.10 ± 10.50 ms and 16.61 ± 3.61 ms, respectively. The following discordance scenarios were evaluated in conjunction with simulated phrenic nerve stimulation: asynchrony-false trigger, dyssynchrony-early trigger, dyssynchrony-late trigger, dyssynchrony-early cycling, dyssynchrony-late cycling. Testing demonstrated none of these discordances were exacerbated by the simulated phrenic nerve stimulation. The novel phrenic nerve stimulation device delivered electrical stimulation therapy as intended and did not exacerbate any simulated discordances.
目前正在研究膈神经刺激术，以预防机械通气支持患者的膈肌萎缩。接受机械通气支持的患者存在呼吸需求与通气支持不匹配的风险。我们的目标是确定一种新型膈神经刺激装置是否能按预期在吸气时提供刺激，且不会加剧任何潜在的不协调情况。开发了一种台式机电模拟模型，以通过模拟呼吸来验证膈神经刺激。使用连接到呼吸模拟器的机械通气机对膈神经刺激装置进行评估。针对多种疾病和通气机参数，测量了膈神经刺激与机械通气之间的触发比率和时间延迟。在1:1呼吸触发比率测试中，99.79%的预期刺激呼吸在正确时间接受了刺激。在1:4呼吸触发比率测试中，99.72%的预期刺激呼吸在正确时间接受了刺激。对于吸气和呼气阶段的触发延迟时间，平均吸气延迟分别为36.10±10.50毫秒和16.61±3.61毫秒。结合模拟膈神经刺激评估了以下不协调情况：不同步-误触发、不同步-早触发、不同步-晚触发、不同步-早循环、不同步-晚循环。测试表明，模拟膈神经刺激并未加剧这些不协调情况。新型膈神经刺激装置按预期提供了电刺激治疗，且未加剧任何模拟的不协调情况。
