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临床试验/CTRI/2024/05/066779
CTRI/2024/05/066779尚未招募不适用

Evaluation Of Handheld Dopplers Accuracy For Heart Rate Assessment Versus Electrocardiogram During Neonatal Resuscitation

Sri Ramchandra institute of higher education and research1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To determine the accuracy of early detection of heart rate using handheld Doppler in comparison to ECG

研究概览

简要总结

Three-lead electrocardiography (ECG) identifies neonatal heart rate more rapidly and accurately and is the gold standard as per neonatal resuscitation guidelines. So, determining whether measuring heart rate using a handheld Doppler is an adjunct device with efficacy like an ECG during neonatal resuscitation will pave the way forward as the first line of measuring in low- resource settings and be easily operable by any trained responder in handling newborn deliveries.

研究设计

研究类型
Observational

入排标准

年龄范围
32.00 Day(s) 至 41.00 Day(s)(—)
性别
All

入选标准

  • Moderate to Late Preterm: 32 0/7–36 6/7 and Term Newborns: 37 0/7–41 6/7 weeks of gestational age undergoing caesarean deliveries at SRMC.

排除标准

  • Skin lesions pose difficulty attaching ECG leads and placing the Doppler probe.
  • If not able to record heart rate with ECG or pulse-oximeter.

结局指标

主要结局

To determine the accuracy of early detection of heart rate using handheld Doppler in comparison to ECG

时间窗: baseline at time of birth to 120 seconds for normal and 300 seconds for babies requiring resucitation

次要结局

  • Determine the average time it takes to achieve a neonatal heart rate through different methods.(baseline at time of birth to 120 seconds for normal & 300 seconds for babies requiring resucitation)
  • Record the time needed for applying various approaches in heart rate assessment(from time of application to time of first initial record of values displayed measured in seconds)
  • Evaluate the effectiveness & practicality of using a handheld Doppler for neonatal heart rate measurement in comparison to ECG & Pulse oximetry(baseline heart rate measurements done over a period of 120 seconds in normal babies & 300 seconds for babies requiring resuscitation using Bland-Altman analysis for comparison)

研究者

发起方
Sri Ramchandra institute of higher education and research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

M Arjun Kumar

Sri Ramachandra institute of medical sciences

研究点 (1)

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