跳至主要内容
临床试验/CTRI/2025/11/096979
CTRI/2025/11/096979尚未招募2 期

A Randomised study to compare the accuracy of conventional method versus cricoid cartilage diameter measurement by ultrasonography for predicting the correct double lumen tube size at SMS Medical College , Jaipur

SAWAI MAN SINGH MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月16日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Assess and compare two methods for predicting correct double lumen tube size

研究概览

简要总结

Double lumen tube is most commonly used device to provide lung isolation in thoracic, mediastinal and vascular surgeries. DLTs isolate lung anatomically and physically. Dlts are available in different sizes because an optimal size is important for optimal positioning. DLT size can be selected according to sex, height but this method lead to selection of inappropriate DLT. There is no uniform standard method for selecting double lumen tube. Imaging such as USG and CT can provide a better measurement. Selection of appropriate double lumen tube is important as if significantly reduces complications associated with an oversized or undersized double lumen tube for effective lung isolation and ventilation during surgery.

Patient is taken in OT. NBM status , PAC written and informed consent will be checked. Patient demographic data are taken like age , sex , BMI, NIBP.

Routine vital monitors are attached for ECG, SpO2, Etco2, Entropy , peripheral IV lines. After randomization patients will be allocated in two groups. Baseline characterstics are noted such as HR , SBP, DBP, MBP {INVASIVE}.

In one group DLT  selection will be done on basis of conventional method and in other group selection is done on basis of cricoid diameter by ultasonography . Variables will be noted such as mean intubation time , no of attempts , time taken for correct placement of tube , difficulty assessment score .  Post operative complications such as sore throat ,dysphagia and hoarseness of voice is also assessed

Stastical analysis is done using appropriate software and conclusions are drawn

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient aged between 18 to 60 years of either sex.
  • 2.American society of anaesthesiologist [ASA] grade class I-III patient 3.Patient requiring one lung ventilation with double lumen tube for thoracotomy.

排除标准

  • Anticipated difficult airway.
  • poor ultrasound image of cricoid cartilage
  • Patient taking part in any other study
  • History of tracheostomy.

结局指标

主要结局

Assess and compare two methods for predicting correct double lumen tube size

时间窗: time taken for correct placement of tube and intubation

次要结局

  • 1.To determine the difference in number of intubation attempt needed in between 2 groups(2. To compare correct size of double lumen tube selected on basis of two methods.)

研究者

发起方
SAWAI MAN SINGH MEDICAL COLLEGE AND HOSPITAL
申办方类型
Research institution and hospital
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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