NCT00730119撤回不适用
Evaluation Of The GE Monitor Product Line
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- This investigation will compare values from the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
研究概览
简要总结
This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
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
- 1 Minute 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent from subject and/or guardian
- •Ability to maintain proper placement of cuff and/or probe and/or sensor
- •Presence of atrial fibrillation or other irregular heart rhythm (when applicable)
- •Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters (SuperSTAT development study only)
排除标准
- •Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
- •Known dysrhythmias (when applicable)
- •Known disease state or medical condition that A) compromises circulation to the extremity, B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin
- •Vigorous exercise prior to participating in the study
- •Excessive movement or excitability causing false values or no determinations
- •Known allergy to latex when latex products will be in contact with subject
- •Subjects who have eaten, drank, smoked or chewed gum in the preceding half hour (temperature parameter only)
- •Nasal/septal defects, cold and/or allergies that would not allow the subject to breathe through their nose (temperature parameter only)
- •Subjects with whom flammable anesthetics will be used.
- •Adult/pediatric subjects,(greater than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 12, but no more than 25 blood pressures on each extremity
- •Pediatric/neonatal subjects,(less than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 10, but no more than 12 blood pressures on each extremity
- •Presence of pacemaker which makes the atrial fibrillation rhythm indistinguishable
- •Subject's limb circumference is outside of the manufacturer's recommended cuff range
- •Subject has Korotkoff sounds that persist to nearly zero (when applicable)
结局指标
主要结局
This investigation will compare values from the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
时间窗: unlimited
次要结局
未报告次要终点
研究者
研究点 (1)
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