跳至主要内容
临床试验/CTRI/2024/09/073255
CTRI/2024/09/073255尚未招募3 期

A Randomized, Comparative Study For The Efficacy Of Three Techniques For Radial Artery Cannulation In Cardiac Surgery Patients At SMS Hospital, Jaipur

Sawai Man Singh Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年9月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
1.To assess the difference in first attempt success rate of radial artery cannulation among the three groups.

研究概览

简要总结

Patient taken in OT

NBM status, PAC consent will be checked.

Patient demographic data are taken (Age, Sex, BMI, NIBP)

Routine vital monitors attached for ECG, SpO2, EtCO2, Entropy Peripheral IV line, IJV central line

After randomisation, Patients (n=150) will be allocated into specific group by sealed envelope method

DNTP                                                           LAX-IP                Conventional Palpation Method

Radial artery profiles are taken such as Left/Right cross- sectional area & depth

Radial artery cannulation procedure is done

Time variables are noted such as Ultrasound scanning time, Skin puncture to blood flashback, Blood flashback to catheter insertion, Total procedure time

Procedural data are recorded such as First attempt success rate, Number of attempts- 1/2/3

Baseline characteristics are noted such as HR, SBP, DBP, MBP (Invasive)

Complications if any such as Vasospasm, Posterior wall puncture, Thrombosis, Hematoma will be noted

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Informed written consent.

排除标准

  • 1.Skin infection at the puncture 2.ASA classification more than or equal to
  • 3.Patient who had received radial artery cannulation within the previous 30 days 4.History of Raynaud syndrome.
  • 5.Peripheral vascular disease.
  • 6.Coagulopathy with significant bleeding tendency before surgery.
  • 7.Morbid obesity Body Mass Index more than 40 8.Negative modified Allen’s test.
  • 9.Patient who doesn’t give consent.
  • 10.Patients who is included in any other study.

结局指标

主要结局

1.To assess the difference in first attempt success rate of radial artery cannulation among the three groups.

时间窗: 1.Number of attempts at baseline | 2.First attempt success rate at baseline | 3.Ultrasound scanning time at baseline | 4.Skin puncture to blood flashback time at baseline | 5.Blood flashback to catheter insertion time at baseline | 6.Total procedure time at baseline | 7.Complications if any.

2.To assess the overall success rate.

时间窗: 1.Number of attempts at baseline | 2.First attempt success rate at baseline | 3.Ultrasound scanning time at baseline | 4.Skin puncture to blood flashback time at baseline | 5.Blood flashback to catheter insertion time at baseline | 6.Total procedure time at baseline | 7.Complications if any.

3.To assess the overall procedure time.

时间窗: 1.Number of attempts at baseline | 2.First attempt success rate at baseline | 3.Ultrasound scanning time at baseline | 4.Skin puncture to blood flashback time at baseline | 5.Blood flashback to catheter insertion time at baseline | 6.Total procedure time at baseline | 7.Complications if any.

4.To assess the number of attempts.

时间窗: 1.Number of attempts at baseline | 2.First attempt success rate at baseline | 3.Ultrasound scanning time at baseline | 4.Skin puncture to blood flashback time at baseline | 5.Blood flashback to catheter insertion time at baseline | 6.Total procedure time at baseline | 7.Complications if any.

次要结局

  • To assess the procedure related complications.(At baseline time, Complications if any such as Vasospasm, Posterior wall puncture, Thrombosis, Hematoma will be noted.)

研究者

发起方
Sawai Man Singh Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Reema Meena

Sawai Man Singh Medical college and Hospital

研究点 (1)

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