Multi-Center Post-Marketing Study Protocol: (MC-PMS) A Single-arm Open Label Observational Study to Further Document the Safety and Effectiveness of the Epidural Space Verification With the CompuFlo® Epidural Computer Controlled System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 11
- 主要终点
- Effectiveness: Visual Analogue Pain Scale
研究概览
简要总结
The purpose of this single arm open-label study is to capture additional data that can add to the original COMPASS (CompuFlo® Assessment Study) clinical trial database that supported the 510(k) application, which was given clearance by the FDA on June 9, 2017.
详细描述
Patients will receive lumbar epidural anesthesia by a HCP, as detailed below. The CompuFlo Epidural System will be utilized only for steps d-g, all other steps are performed in the same way as with the Loss of Resistance Syringe. Refer to User Manual for detailed instructions on how to set up the system.
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American Society of Anesthesiologists standard monitors will be attached and patients will be placed in a sitting position. Sedation will not be permitted due to potential confounding of the data and/or making it impossible to assess neurological injury/paresthesias during the procedure. Limited Vital signs (blood pressure, apical heart rate, oral temperature, respiration rate) will be obtained and documented in the CRF.
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Set up the CompuFlo System disposable kit and attach kit to instrument.
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Connect the pressure sensor to the ID adapter.
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Connect the ID adapter to the CompuFlo instrument.
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Connect the external pressure sensor to the filled 20 mL syringe.
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Connect the extension tubing to the other end of the pressure sensor.
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The lumbar area will be disinfected and draped in the usual fashion. The skin in the lumbar area will be locally infiltrated with a local anesthetic solution, according to local practice.
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The epidural needle will be introduced in the lumbar area to a depth of approximately 3 cm. Insertion to a depth of 3 cm is typical in clinical practice, to avoid accidental epidural space puncture by inserting the needle too deep, while at the same time inserting the needle to a depth at which it will be supported by the tissue.
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Purge (i.e., prime) the extension tubing connected to the CompuFlo instrument.
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The CompuFlo extension tubing set will be held at the same vertical height as the puncture level of the epidural needle to calibrate the pressure by depressing the "Zero" button of the CompuFlo® instrument. This will zero the pressure prior to connection of the epidural needle to the extension tubing. The stylet of the epidural needle will be removed and extension tubing will be connected after making the zeroed pressure calibration at the puncture's level.
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The CompuFlo Epidural Instrument will be set to deliver normal saline at a rate of 0.050 mL/sec during these measurements with an exit-pressure limit not to exceed 120 mm/Hg.
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The epidural Tuohy needle (18-gauge 3-1/2 inch or any other size) will then be advanced until the pressure readings on the CompuFlo Epidural System indicate position in the epidural space as defined below.
The following criteria is used to differentiate a True-Loss of Resistance (True-LOR) versus the identification of a False-Loss of Resistance (False-LOR) using the CompuFlo Epidural Instrument:
A True-LOR defined as:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is at least 18 years of age at screening, but has not had his/her 91st birthday.
- •The subject is required to have epidural procedure implemented as part of their standard medical treatment according to Principal Investigator assessment.
- •The subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment into this study.
- •The subject is willing to participate in this study for at least 30 days after the epidural procedure implementation.
- •The subject is willing to participate in this study for at least 3 days after the procedure.
排除标准
- •Contraindications for epidural procedure / anesthesia (circumstances where the risks associated with epidural procedures are higher than usual. These circumstances are, but not limited to, anatomical abnormalities, such as spina bifida or scoliosis, infection at or near the site of insertion, allergy to the anesthetic or intended drug, uncorrected hypovolemia, increased intracranial pressure etc.).
- •Patients presenting for emergency C-section or other emergencies.
- •Exclusive use of other treatments such as intravenous analgesia with opioids.
- •Prior back surgery in lumbar area that would prevent epidural access.
- •Preexisting neurological deficit that would interfere with dermatome identification.
- •The subject observed seizure within 7 days prior to study enrollment.
- •Presumed and/or confirmed septic embolus.
- •The subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region greater than 4 cm
- •The subject previously participated in another investigational drug or device trial within the preceding 4 weeks.
- •Severe co-existing or terminal systemic disease that limits life expectancy or may interfere with study procedures.
- •The subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study
结局指标
主要结局
Effectiveness: Visual Analogue Pain Scale
时间窗: 20 minutes
Number of patients with Visual Analogue Pain Scale (VAPS ) score (0 = non pain; 100 = maximum pain) less than 20 after 20/30 minutes from the epidural analgesic loading dose or for those patients for whom fluoroscopy is performed: Number of patients having correct spread of dye in the epidural space as observed by fluoroscopy
Epidural identification
时间窗: 15 minutes
To Identify and differentiate True-LOR vs. False-LOR and/or Inconclusive-LOR during ES identification by using the Compuflo Epidural Instrument recordings of pressure (delta, mmHg) A True-LOR defined as: An increase in pressure followed by a sudden and sustained (\> 5 seconds) drop in pressure (mmHg) resulting in the formation of a low and stable pressure plateau A False-LOR defined as: An increase of pressure (mmHg) followed by a drop in pressure that is either not sustained or inconclusive of representing a "low and stable pressure plateau" If the pressure (mmHg) rapidly increases after a drop of pressure this is identified as a False-Loss of Resistance and the operator may elect to continue to advance the needle.
Complications
时间窗: 36 hours
Number of patients having inadvertent dural punture Number of patients having post dural punture headache
次要结局
- Secondary Epidural Veriification(15 minutes)
- Physician Concordance Index(24 hours)
研究者
Capogna Giorgio
Director EESOA
European e-Learning School in Obstetric Anesthesia