A Randomized Control Trial of the Oxistimulator as an Adjunct to Standard Practice to Decrease Extent and Duration of Oxygen Desaturation in Adult Patients Who Have Received Anesthetics or Are Receiving Sedating Medications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Area Under the Curve for oxygen saturation (SpO2%)
研究概览
简要总结
This study is designed to determine if using peripheral nerve stimulation in conjunction with pulse oximetry as an adjunct to traditional monitoring in the PACU reduces the frequency and severity of sedation related apnea and hypoxic events.
详细描述
The primary effectiveness objective is to determine if transcutaneous stimulation will generate a respiratory response capable of reducing the extent and duration of oxygen desaturations in patients with presumed risk of obstructive sleep apnea (OSA) who have received some form of anesthesia or sedation. The primary safety objective is the demonstration that the peripheral nerve stimulation is safe for the use of preventing or reducing the sedation related hypoxemic events.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •Peripheral neuropathy involving the upper extremities
- •Procedures requiring direct admission to the ICU or any site other than the post-anesthesia care unit from the OR
- •Diagnosed obstructive sleep apnea (OSA) and / or use of continuous positive airway pressure (CPAP) or biphasic positive airway pressure (BiPAP) in the PACU.
- •Presence of any implantable electric devices, including internal defibrillators, pacemakers, or left ventricular assist device (LVAD)
- •Post-procedure temperature < 35.5 Celsius or evidence of vasoconstriction
- •Presence of metal hardware in either arm or in either shoulder
- •Patients lacking access to the bare skin on an arm after surgery.
- •History of atrial fibrillation
- •History of bundle branch block
- •Females from menarche to menopause that do not have a current negative pregnancy test or surgical history preventing pregnancy.
研究组 & 干预措施
Stimulator Active Device
Intervention: This intervention arm will use a Stimulator Active Device peripheral nerve stimulation. Participants will receive a cutaneous stimuli in response to oxygen desaturations in postoperative surgical patients.
干预措施: Stimulator active device (Device)
Stimulator Sham Device
No intervention: This arm will use a Stimulator Sham Device peripheral nerve stimulation.Participants will not receive a cutaneous stimuli in response to oxygen desaturations in postoperative surgical patients.
干预措施: Stimulator sham Device (Device)
结局指标
主要结局
Area Under the Curve for oxygen saturation (SpO2%)
时间窗: One hour
次要结局
- Frequency of desaturation episodes(One hour)
- Frequency of nursing interventions(One hour)
- Frequency of Adverse Events(72 hours)
研究者
Hugh M. Smith
Principal Investigator
Mayo Clinic