A Prospective, Single-center Clinical Pilot Study Evaluating Feasibility of the Swiftsure Complete Care System (CCS) in Intubated Adults Undergoing Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Procedural success
研究概览
简要总结
The purpose of this study is to investigate the feasibility of using the Swiftsure Complete Care System (CCS) device as an adjunct to standard oral care procedures among intubated adult patients undergoing mechanical ventilation in the intensive care unit (ICU).
This is a small study intended to gather initial feasibility before conducting a larger study. The feasibility of using the Swiftsure CSS device will be studied among 20 patients at a single study site.
详细描述
This is a prospective, single-center, single-arm, non-blinded trial to assess the feasibility of using the Swiftsure CSS device as an adjunct to the standard oral care among intubated adult patients undergoing mechanical ventilation in the ICU.
The CSS intervention will be performed 1 times per subject. The nurse performing the intervention will be asked to complete the study questionnaires after each device use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Cardio-Vascular Intensive Care Unit (CVICU) patients recovering from surgery and expected to undergo mechanical ventilation for at least 6 hours
- •18 years or older
排除标准
- •Unable to consent
- •Maxillofacial trauma
- •Agitation
- •Tested positive for COVID-19 at screening
- •Any condition precluding positioning required for device use (e.g. increased intracranial pressure, spine instability, presence of spine drain etc)
- •Oropharyngeal injury or infection
- •Respiratory infection
- •Difficult Airway Grade III or higher
- •Intubated with a double lumen tube
- •Tracheostomy
- •Endotracheal tube cuff air leak, defined as inspiratory-to-expiratory tidal volume difference higher than 10% or audible gurgling at cuff pressure higher than 30 cmH2O
- •Poor dental status
- •Hemodynamic instability, defined as need for 2 or more vasopressor agents, or use of mechanical hemodynamic support (e.g. intra-aortic balloon pump, Impella heart pump, Left Ventricular Assist Device, venous- arterial extracorporeal membrane oxygenation)
- •Respiratory instability, defined as PaO2/FIO2 < 300 mmHg on PEEP > 10 cmH2O, or respiratory acidosis with pHa < 7.30 and respiratory rate > 20, or use of inhaled pulmonary vasodilators
- •Pregnancy or not using anti-conceptional agents in child bearing age
- •Patients with difficult intubation
结局指标
主要结局
Procedural success
时间窗: 1 to 4 hours post-procedure
Procedural success, defined as successful completion of the full procedure to use the Swiftsure CCS device, and standard oral care,
次要结局
- Usability of Swiftsure CCS device(1 to 4 hours post-procedure)