Self-invented Intracavitary ECG Wire VS the Commercial System - Certodyn®
赞助:
Mahidol University
合作者:
信息的提供 (责任方):
Prasert Sawasdiwipachai，Mahidol University
| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | August 1, 2018 | ||
| 预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Signal noise ratio[ Time Frame: 10 min ] Measuring the segment of ECG noise (if exists) in millimeters compare to the total ECG segment. Compare this signal noise ration between the baseline surface ECG, the self-invented wire derived iECG and the Certodyn derived iECG. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Self-invented Intracavitary ECG Wire VS the Commercial System - Certodyn® | ||
| 正式标题 ICMJE | Comparison of the Self-invented Intracavitary ECG Wire With the Commercial System - Certodyn® | ||
| 简要概况 | Peripherally Inserted Central Catheter (PICC) is considered a central venous line placement (CVL) which mandates the confirmation of the tip's location. At present, most CVL's position are confirmed by radiographic method either by in-procedure fluoroscopy or post-insertion x-ray. For CVLs placed from upper body (from internal jugular vein, subclavian veins or upper arm veins), the intracavitary electrocardiogram (iECG) can also be used. Intracavitary ECG are proven effective for tip confirmation and provide some benefits i.e. lower cost, decrease exposure to harmful radiation for care providers and also the patients, require less personals and equipments, provide real-time confirmation as comparable to fluoroscopy, etc. There are several devices and makes of iECG apparatus but B.Braun-Certodyn® remains the only available system in Thailand. The limitation is the availability of the Certodyn devices on each locations where CVL will be placed i.e. operating theater, intensive care unit, bedside placement, radiology suite, etc. Since the connecting wire is only supplied in the certain CVL kits under B.Braun brand, this has rendered iECG for other types or makes of CVL or PICC line become even more difficult. Self-invented connector wire for iECG (PS wire) has been made and used effectively in the past few years at Siriraj hospital. The patent registration is underway and the author seek to compare this PS wire against the commercial Certodyn system. |
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| 详细说明 | Objective 1. To evaluate the success rate of iECG CVL tip confirmation by self-invented iECG connector wire. 2. To compare quality of iECG tracing produced from both of self-invented iECG wire versus the Certodyn system. Materials, participants and study method Equipments required: 1) Self-invented iECG wire (PS wire) 2) Commercial iECG system which consists of the Certodyn and the wire. 3) Standard ECG monitoring system which can display and printout the ECG tracing. 4) A digital ECG caliper which can measure P wave amplitude and noise segment in millimeter up to 2 decimal points. Study method 1. Patient presented for PICC line from upper torso will be screened and assessed for eligibility. 2. Exclusion criteria includes children younger than 18 yo, patient with atrial fibrillation or other rhythms not generated from intrinsic SA node i.e. pacer, unstable hemodynamic, patient with history arrhythmias, HR > 120 bpm, patients with hypercoagulable state, allergy to heparin or patients with known heparin induced thrombocytopenia, patients with known Creutzfeldt-Jakob Disease 3. Obtain informed consent. 4. Patient will be monitored with standard 3-lead ECG, the baseline lead II ECG will be printed out and tagged with a serial number. 5. Patient will undergo the standard PICC line placement using Seldinger or modified Seldinger technique. The catheter will be pre-flushed with 10 units/mL heparinized NSS. When Figure 1: A spreadsheet of 2 parameters measured in 10 pilot cases Figure 2: A captured screen of nQuery for calculation of sample size, the first 2 columns were calculated from the P wave amplitude and the last 2 columns were from the noise segment catheter is inserted into the proximal SVC (guided by landmark measurement), the wire will be retracted to the marked location where the tip of the wire is at the end of the catheter. The iECG connection by Certodyn will be applied. The catheter and wire will be adjusted until the giant P wave (highest P) was detected on screen, this ECG tracing will be printed out and tagged with another non-sequential serial number. The iECG will then switched to the PS wire and the iECG tracing will be printed out again and tagged with another non-sequential serial number. All 3 ECG printouts will be stapled together for measurement by cardiologist who is blind to the intervention later. 6. The intervention related to research study is considered ended at this point. The patient will have their CVL/PICC line adjusted to the proper position (mid to distal SVC for mid-long term and long term catheter). The CVL or PICC will be secured, flushed and locked per standard protocol. 7. Portable CXR will be routinely obtained when patients arrived to the ward. The information of the tip of the catheter will be recorded as well. Data analysis 1. Demographic data, type of catheter, depth of catheter where giant P wave obtained and final position of catheter will be recorded. 2. Each study patient produce 3 ECG print outs which are -baseline surface lead II ECG - iECG produced by Certodyn system - iECG produced by PS wire Each ECG tracing will be evaluated and measured by a cardiologist who is blind to the intervention. The 2 measured parameters includes: - The amplitude of P wave in mm from baseline surface ECG of each cardiac cycle. -The amplitude of giant P wave in mm from iECG from both Certodyn and PS wire. 3. All 3 ECG print outs will be compared for quality and the length noisy ECG segment (determined as the ECG with interference artifact of baseline > 1 mm) will also be measured in mm. 6) All measurement will be analyzed statistically to determine the differences between the 2 systems. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Non-Randomized 干预模型: Crossover Assignment 干预模型描述: Single center, prospective, cross over study 盲法: Interventional 盲法描述:unlabeled ECG print 主要目的: Diagnostic |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
36 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 31, 2019 | ||
| 预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Patient age 18 years and above. - Requires PICC line insertion from upper torso. Exclusion Criteria: - Children younger than 18 years. - Patient with atrial fibrillation or other rhythms not generated from intrinsic SA node i.e. pacer, atrial fibrillation, etc. - Unstable hemodynamic. - Patient with history arrhythmias. - Patient with HR > 120 bpm. - Patients with hypercoagulable state. - Allergy to heparin. - Patients with known heparin induced thrombocytopenia. - Patients with known Creutzfeldt-Jakob Disease. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Thailand | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Prasert Sawasdiwipachai，Mahidol University | ||
| 研究赞助商 ICMJE | Mahidol University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Mahidol University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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