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临床试验/NCT07373171
NCT07373171尚未招募不适用

Evaluation of Different Sizes of Left-Sided Double-Lumen Tubes for Thoracic Surgery in a Tertiary Level Teaching Hospital

Tribhuvan University, Nepal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Ease of intubation using a 35 Fr DLT

研究概览

简要总结

Double lumen tubes (DLT) have become standard of care for one lung ventilation in thoracic and esophageal surgeries. Selection of accurate size of DLT is important to achieve proper one lung ventilation, prevent trauma to airway, easy intubation, prevention of displacement of DLT and adequate oxygenation intraoperatively. There are no definitive guidelines to select the correct size of DLT. The aim of this study is to observe if there is any difference in the number of intubation attempts, intraoperative oxygenation and postoperative sore throat while using 35 Fr DLT size and other DLT size. The research will be conducted between Ashoj 1st 2082 to Chaitra 30 2082 at Manmohan Cardiothoracic Vascular and Transplant Center(MCVTC). Fifty patients aged more than eighteen years undergoing thoracic surgery requiring One Lung Ventilation(OLV) with left sided DLT will be selected for the study. Participants will be randomly assigned to 35 Fr DLT size group or DLT size group according to the height. Patients in both the groups will be given the samepreoperative care, intraoperative care and postoperative care. Besides patient's demography, diagnosis and operative procedure; number of intubation attempts, modified Cromack-Lehane(CL) grade, size of DLT, intraoperative oxygen saturation SpO₂ and postoperative sore throat on day of surgery and first postoperative day will be recorded. Statistical analysis will be done using t- test for independent variable, confidence interval for outcome of sore throat, significance of difference for number of male and female; rates, risk ratio and odds ratio will be calculated using 2x2 contingency table. P ≤ 0.05 will be considered statistically significant. Our expected outcome is 35 Fr DLT are easier to intubate, does not affect intraoperative oxygenation and decrease the incidence of postoperative sore throat.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18 years or older undergoing thoracic surgery requiring OLV with placement of a left-sided DLT

排除标准

  • Patient refusal
  • Need for rapid sequence intubation (RSI) due to increased aspiration risk
  • Anticipated difficult intubation
  • Emergency surgery
  • Patient already intubated with a single-lumen ET tube
  • DLT tube change to single lumen tube at the end and shifted with ETT in situ

研究组 & 干预措施

35 Fr group

Experimental

干预措施: Intubation of patients undergoing thoracic surgery with left sided double lumen tube (Device)

DLT size according to height

No Intervention

结局指标

主要结局

Ease of intubation using a 35 Fr DLT

时间窗: Day 1

Ease of intubation is assessed using "number of intubation attempt and "Cormack-Lehane grade" that will be determined by anaesthesia provider who is intubating. The number of intubation attempt is the tube pass attempt during intubation and Cormack-Lehane grade is the percentage of vocal cord structure visualized during direct laryngoscopy. Number of intubation attempt and cormack-Lehane grading will be recorded in the proforma of the study.

Difference in intraoperative oxygenation between 35 Fr and different sizes of DLT

时间窗: Day 1

The percentage of oxygen saturation( SpO2 %) will be recorded at 5 minutes and 10 minutes after one lung ventilation from the ventilator monitor attached to the patient in the operation room. The percentage of oxygen saturation will be recorded in the study proforma and later compared between the groups.

Postoperative sore throat

时间窗: Day 2

Postoperative sore throat will be assessed using a yes/no question asked by an attending nurse in the post operative ward within 24 hours of postoperative period. If the patient has sore throat then it will be graded. The question and grade will be as follow Do you have a sore throat: (yes/no) if the answer is yes then graded as 0 = no sore throat 1. = mild sore throat (complains of sore throat only on asking) 2. = moderate sore throat (complains of sore throat on his/her own) 3= severe sore throat (change of voice or hoarseness, associated with throat pain The answer and grade will be recorded and later analysed between the groups

次要结局

未报告次要终点

研究者

发起方
Tribhuvan University, Nepal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jog Adhikari

MD resident Doctor

Tribhuvan University, Nepal

研究点 (1)

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