重振研究 - - 神经到隔膜刺激,用于从机械通风中断奶:一个随机关键临床试验的协议
Katie Schaaf1, Christopher M Mullin2, Kyle W Cunningham3
1Stimdia Medical, Inc, 1355 Mendota Heights Road, Suite 300, Mendota Heights, MN, 55120, USA.
Trials
|August 2, 2024
概括
通过神经刺激进行电动膜节奏可能有助于患者更快地摆脱机械通风. "再振兴试验"研究了这种新的治疗方法,用于难以断奶的个人.
科学领域:
- 关键护理医学 关键护理医学
- 呼吸系统生理学 呼吸系统生理学
- 生物医学工程 生物医学工程
背景情况:
- 机械通风 (MV) 与显著的发病率,更长的住院时间和成本增加有关.
- 隔膜功能障碍是MV的常见并发症,阻碍了成功的断奶.
- 神经刺激是一种潜在的策略,可以在MV期间减轻腹膜功能障碍.
研究的目的:
- 评估pdSTIM系统的安全性和有效性,以促进MV的断奶.
- 评估隔膜节拍对机械通风释放时间的影响.
- 探索一种新疗法的潜力,用于患有难以断奶的患者.
主要方法:
- 预期的,多中心的,随机的,受控的临床试验 (重振试验).
- 使用pdSTIM系统,通过皮肤放置电极进行双边神经刺激.
- 注册患者在MV上≥96小时,至少有一次断奶尝试失败.
主要成果:
- 主要终点:成功从机械通风中释放的时间 (治疗与控制).
- 二级终点包括快速浅呼吸指数和生理参数.
- 安全数据将对所有参与者进行总结.
结论:
- 这项研究研究了一种首创的治疗方法,用于ICU中难以断奶的患者.
- 这项技术,如果被证明是有效的,可以在通风机断奶方面取得重大进展.
- 该试验是根据美国FDA的研究设备豁免进行的.
相关概念视频
Mechanical Ventilation III: Noninvasive Ventilation
88
Noninvasive positive-pressure ventilation (NIPPV), continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) are essential methods in respiratory care. These ventilation techniques offer unique benefits for patients with various respiratory conditions, providing adequate support without requiring intubation. Let's explore how each method is crucial in improving patient outcomes and enhancing respiratory therapy.
Noninvasive Positive-Pressure Ventilation...
Noninvasive Positive-Pressure Ventilation...
88
Mechanical Ventilation II: Invasive Ventilation
122
Ventilators are essential medical equipment used to aid patients with respiratory difficulties. Their primary function is to assist or replace spontaneous breathing by providing mechanical ventilation. There are two general classes of mechanical ventilators: negative-pressure and positive-pressure ventilators.
Negative-Pressure Ventilators
Negative-pressure ventilators create a vacuum around the chest or body to draw air into the lungs, simulating breathing. This method does not require an...
Negative-Pressure Ventilators
Negative-pressure ventilators create a vacuum around the chest or body to draw air into the lungs, simulating breathing. This method does not require an...
122
Mechanical Ventilation I: Indication and Settings
241
Mechanical ventilation is a life-saving technique for managing acute respiratory failure and other respiratory complications. The process involves using a machine known as a ventilator to supply oxygen to the lungs and assist in removing carbon dioxide. It serves as a bridge to long-term mechanical ventilation or a temporary measure until ventilatory support is discontinued. The ventilator can maintain this function for a prolonged period, providing critical support for patients until they can...
241
Physiology of Respiration II: Neurogenic Control of Respiration
598
The neurogenic control of respiration coordinates various neural networks and pathways to regulate breathing rate and depth, meeting the body's oxygen and carbon dioxide exchange requirements. This system adapts to physiological and environmental conditions, ensuring optimal breathing patterns.
Central Control
The brainstem is the primary site of central control, hosting respiratory centers:
Central Control
The brainstem is the primary site of central control, hosting respiratory centers:
598
Tracheostomy Decannulation
140
Tracheostomy decannulation is a significant milestone in the liberation of mechanically ventilated patients. Despite its importance, there is no universally accepted protocol for this procedure. This demands an evidence-based, individualized approach.
Description of the Procedure
Decannulation refers to the permanent removal of the tracheostomy tube, signaling the resolution of the condition that initially necessitated the tracheostomy. The process requires a well-coordinated interplay between...
Description of the Procedure
Decannulation refers to the permanent removal of the tracheostomy tube, signaling the resolution of the condition that initially necessitated the tracheostomy. The process requires a well-coordinated interplay between...
140
Acute Respiratory Failure-III
167
Hypercapnic respiratory failure, also known as Type 2 or ventilatory respiratory failure, is a severe condition characterized by the body's inability to effectively remove carbon dioxide (CO2) from the bloodstream. It leads to an arterial CO2 pressure (PaCO2) exceeding 45 mmHg and a blood pH above 7.35. This situation indicates that the body's ventilatory demand, or the ventilation needed to maintain normal PaCO2 levels, surpasses its supply or the maximum gas flow achievable without...
167


