CTRI/2012/04/002580已完成3 期
To Validate the Accuracy of CSI 9100 Series Patient Monitor (Automated Non-Invasive Blood Pressure Sphygmomanometer) in the linear Deflate Mode in Adults, Children, Neonates and Infants as per ANSI/AAMI/ISO 81060-2:2009. - Nil
Opto Circuits India Ltd0 个研究点目标入组 188 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria for adults/children:
- •1.Adult and children coming for any routine Out-Patient Division clinic/procedure.
- •2.Willingness to participate after signing informed consent.
- •3.Age >= 12 years (in case of adolescents/adults) or between 3 to 12 years (in case of children).
- •Inclusion Criteria for neonates/infants:
- •1.Willingness to participate after informed assent by the patientâ??s legal guardian.
- •2.Aged between 29 days and 3 years.
- •Presence of intra-arterial BP line.
排除标准
- •Exclusion Criteria for adults/children:
- •1.Female patients who are pregnant or lactating.
- •2.Patients with pace-maker implantation.
- •3.Patients suffering from cardio-respiratory, neurological or endocrinal disorders which in judgement of the Investigator deemed unfit for the study inclusion as evident from the medical history/concurrent illness(s).
- •4.Patients with alcohol abuse/dependence.
- •5.Patients based on abnormal rhythms as evident by the current ECG and medical history/concurrent illness(s). Patients with atrial fibrillation, premature ventricular beats, peripheral arterial disease, (rhythms as evident by the current ECG and medical history) and have been medically advised not to have stress testing exercises.
- •6.Medical or surgical indication that might prevent use of BP cuffs.
- •Exclusion Criteria for neonates/infants:
- •1.Patients with pace-maker implantation.
- •2.Patients suffering from illnesses with an intra-arterial BP line which in judgement of the Investigator deemed unfit for the study inclusion or assessment as evident from the medical history/concurrent illness(s).
- •3.Patients based on abnormal rhythms as evident by the current ECG and medical history/concurrent illness(s). Patients with atrial fibrillation, premature ventricular beats, peripheral arterial disease, (rhythms as evident by the current ECG and medical history).
- •4.Maternal drug or alcohol dependence.
- •5.Medical or surgical indication that might prevent use of BP cuffs.
- •6.Patients on mechanical ventilation.
研究者
相似试验
招募中
4 期
ECG device validatioCTRI/2019/10/021814TenT Healthcare Pvt Ltd
已完成
Unknown
Investigation of the accuracy and physiological significance of body temperature fluctuations measured by continuous body temperature measurement devices and the relevance of circadian transition in peripheral blood immune cellsHealthy control and febrile diseaseJPRN-UMIN000049725Keio University24
暂停
不适用
Prospective study on accuracy verification of continuous noninvasive finger arterial pressure measurementEsophageal cancerJPRN-UMIN000032439Tohoku university graduate school of medicine, Department of anesthesia and perioperative medicine50
已完成
不适用
To Investigate the Precision and Agreement of SS-1000 and Pentacam in a Repeatability and Reproducibility TrialEvaluate the Agreement and Precision of Device SS-1000 and the Predicate Device the Pentacam in a Reproducibility and Repeatability TrialNCT02077790Tomey Corporation66
已完成
不适用
Testing of the reliability of the Radner reading chart.maculopathy10047060macular degenerationNL-OMON30878Oogziekenhuis Rotterdam36