Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 38
- 主要终点
- Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.
研究概览
简要总结
A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts. The goal is to strengthen and rehabilitate the diaphragm to liberate the patient more quickly from mechanical ventilation.
详细描述
Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventricular induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as short as 18 hours. The Lungpacer Diaphragm Pacing Therapy System (DPTS) is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the Lungpacer Control Unit system. The LIVE Catheter is a proprietary central venous catheter that incorporates pacing electrodes in strategic areas that align with the left and right phrenic nerves. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. The randomized clinical trial will investigate the safety, effectiveness and performance of the Lungpacer DPTS. By stimulating the diaphragm through daily therapy sessions, with the intention of exercising and rehabilitating the diaphragm muscle so the patient may be able to be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for greater than or equal to 96 hours (4days), have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest spontaneous breathing trial. Patients must have resolution of the initial indication for placement on mechanical ventilation before entering the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The ultrasound core lab reviewers will be blinded to study allocation groups
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •have been mechanically ventilated for > or = to 96 hours (4 days), and
- •have satisfied the Readiness-to-Wean criteria and
- •have failed at least two VLTs, one of which is the study specific VLT.
排除标准
- •currently on extracorporeal membrane oxygenation (ECMO);
- •weaning failure due to hypervolemia;
- •medical history or known anatomy that prevents insertion of the LIVE Catheter into the left subclavian vein;
- •currently being treated with neuromuscular blockade;
- •clinically overt congestive heart failure that is preventing weaning;
- •pre-existing neuromuscular diseases that could affect the respiratory muscles;
- •pre-existing severe chronic pulmonary fibrosis;
- •pleural effusions occupying greater than one third of the pleural space on either side;
- •BMI > or = 40;
- •known or suspected phrenic nerve paralysis;
- •any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators;
- •prior bacteremia reported within the last 48 hours;
- •current hemodynamic instability, sepsis or septic shock;
- •terminally ill with 6 months or less life expectancy or not committed to full care;
- •known or suspected to be pregnant or lactating; and
- •currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.
结局指标
主要结局
Proportion successfully weaned by 30 days for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.
时间窗: Patients will be allowed to stay in the study for up to 30 (+2 days of follow up for adverse events) days if not removed from mechanical ventilation sooner
"Successfully weaned" is defined as passing the protocol-specific Ventilator Liberation Trial (VLT), or removed from MV, and not reintubated (subjects with an oral or nasal, endotracheal tube) or returned to MV (subjects with a tracheostomy) within 48 hours
次要结局
- Changes in MIP(to successful weaning, or on day 30, whichever comes first.)
- Days on mechanical ventilation(from randomization to 30 days)
- Mortality(on day 30)
- Changes in diaphragmatic thickening fraction on diaphragm ultrasound(to successful weaning or on day 30 which ever comes first.)
- Change in MIP(to successful weaning, or on day 30 whichever comes first.)
- Changes in RSBI(to successful weaning, or on day 30, whichever comes first)
- Change in RSBI(to successful weaning, or on day 30, whichever comes first)