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临床试验/CTRI/2025/06/089602
CTRI/2025/06/089602尚未招募不适用

TO ANALYSE THE EFFECT OF TOURNIQUET RELEASE IN DIFFERENT LIMB POSITIONS ( i.e neutral and elevated to 30 degree from neutral position ) ON HEMODYNAMIC PARAMETERS ( i.e HR , BP , SpO2 , Core temperature , End tidal CO2 and respiratory rate ) IN LOWER LIMB ORTHOPAEDIC SURGERIES

Dr Rajas Rawal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月31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
100
试验地点
1
主要终点
To measure and compare the changes in hemodynamic parameters i.e heart rate , blood pressure , oxygen saturation and core temperature in neutral and upwards inclination of 30 degrees limb position after tourniquet is released .

研究概览

简要总结

Monitoring of hemodynamics will be done throughout the orthopaedic procedure including after inflation of tourniquet . The purpose of the study is to measure and compare changes in hemodynamic parameters i.e heart rate , blood pressure , oxygen saturation and core temperature in neutral and upwards inclination of 30 degrees limb position after tourniquet is released and to measure and compare changes in respiratory rate and EtCO2 levels in neutral and 30 degrees limb elevation after tourniquet is released . The study enrolling of 100 subjects will be randomly allocated into two groups , Group A ( 50 subjects ) whose hemodynamic parameters monitoring shall be done after tourniquet deflation in neutral position and Group B ( 50 subjects ) whose hemodynamic parameters monitoring shall be done after tourniquet deflation in elevation of 30 degrees from neutral position .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subjects undergoing lower limb orthopaedic surgeries Subjects Grade I and II of ASA Subjects with tourniquet inflation duration greater than 1 hour.

排除标准

  • Subjects not willing to consent Subjects Grade III and IV of ASA Subjects with tourniquet inflation duration greater than 2 hours Subjects undergoing bilateral lower limb orthopaedic procedure.

结局指标

主要结局

To measure and compare the changes in hemodynamic parameters i.e heart rate , blood pressure , oxygen saturation and core temperature in neutral and upwards inclination of 30 degrees limb position after tourniquet is released .

时间窗: Hemodynamic parameters monitoring will be done at intervals of 1 minute , 3 minute , 5 minute and 10 minute .

次要结局

  • To measure and compare changes in respiratory rate and EtCO2 levels in neutral and 30 degrees limb elevation after tourniquet is released(The parameters monitoring will be done at intervals of 1 minute , 3 minute , 5 minute and 10 minute .)

研究者

发起方
Dr Rajas Rawal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rajas Rawal

Maharishi Markandeshwar Medical College and Hospital

研究点 (1)

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