跳至主要内容
临床试验/CTRI/2024/12/078127
CTRI/2024/12/078127招募中Phase 3 4

Comparison of 110 degree anticlockwise rotation and conventional 90 degree rotation for successful placement of left double-lumen tubes: A randomised controlled trial

AIIMS1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年12月26日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
AIIMS
入组人数
200
试验地点
1
主要终点
To compare the first success rate of left DLT placement into left main bronchus using 110 degree anticlockwise rotation with respect to conventional 90 degree rotation.

研究概览

简要总结

Double lumen tubes (DLTs) appear to be a favourable method for the airway management during one lung ventilation (OLV) in thoracic surgery. Most commonly left sided DLT is used for OLV due to the anatomical advantage of left bronchus over right bronchus. Despite of the above fact it has been found that left sided DLT get misplaced to right main bronchus in about 4.2 % cases, especially in females and short stature patients.

Traditionally, it is thought that left and right bronchi divide in the same plane from trachea so left sided DLT to be rotated 90 degrees anticlockwise after bronchial tip of DLT has crossed the vocal cord to position bronchial lumen to left main bronchus. However, this conventional approach has been questioned by recent studies which suggest that left bronchus divide at an angle more than 90 degree with more posterior inclination. One study based on ct scan analysis of tracheobronchial tree had suggested that 110 degree anticlockwise rotation instead of conventional 90 degree anticlockwise rotation of DLT, whereas another study has advocated individualised rotation of DLT.[ Nevertheless, dimensions of  tracheobronchial tree vary in different races the findings of above studies  may not be reciprocated in Indian population. Hence,we plan this study  to determine the angle of anticlockwise rotation of left sided DLT for its optimal placement in indian population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients with age ≥ 18 years who are scheduled for thoracic surgery and requiring left sided DLT insertion for OLV.

排除标准

  • Anticipated difficult airway such as Malampati score ≥ 3 Previously tracheostomized patients Previously operated case of cervical spine surgery Presence of intratracheal or left intrabronchial mass.

结局指标

主要结局

To compare the first success rate of left DLT placement into left main bronchus using 110 degree anticlockwise rotation with respect to conventional 90 degree rotation.

时间窗: after DLT placement

次要结局

  • To determine the true mean anatomic angle of left main bronchi with respect to trachea using three-dimensional CT scan (3D CT) in Indian population(To compare the incidence of carinal mucosal injury between the above two degree of rotation groups.)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Subodh Kumar

AIIMS, New Delhi

研究点 (1)

Loading locations...

相似试验