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临床试验/CTRI/2024/05/067112
CTRI/2024/05/067112招募中不适用

Comparison of effect of one lung ventilation(OLV) Vs two lung ventilation(TLV) in video-assisted thoracoscopic (VATS) esophagectomy: An observational study

Dr Prashant K Desai1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
82
试验地点
1
主要终点
1.To Assess the ratio of PaO2 to fraction of inspired oxygen (PaO2/FiO2)

研究概览

简要总结

This study is a Prospective observational study, comparing the effects of one lung ventilation(OLV) Vs two lung ventilation(TLV) in video assisted thoracoscopic(VATS) esophagectomy.Group A: Patient with One lung Ventilation (OLV) using Single Lumen Tube (SLT) and Bronchial Blocker (BB) in Lateral Position. Group B: Patient with Two Lung Ventilation (TLV) using SLT in Prone Position. After Positioning the patient, in Group A Lateral Position and In Group B Prone Position, Arterial blood gas analysis will be done for the following parameters, partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2) and (Pao2/Fio2 ratio), the ratio of PaO2 to fraction of inspired oxygen, will be measured during pre-insufflation (T1), post insufflation (20 minutes) (T2), and in the interval of 1hr (T3), 2hr (T4), 3hr (T5) intraoperatively followed by 24hr (T6), and 48hr (T7) Postoperatively. Intraoperatively episodes of desaturation with duration and action taken for the same will also be noted. Patient will be monitored throughout the surgery as per standard protocol and patient will be shifted to ICU for further monitoring. For secondary outcomes, Postoperative inflammatory parameters like body temperature, heart rate, C-reactive protein, and Total leukocyte counts will be assessed after immediate post op and at an interval of 24hr and 48hr.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients consenting to the study who are undergoing VATS surgery.
  • Adult patients between 18 and 60 years of age, of either sex.
  • ASA I & II patients.

排除标准

  • Patients not consenting to the study.
  • Patient with Restrictive Lung Disease.
  • ASA III and IV patients.
  • Cases converting VATS to open procedure.
  • Breath holding test less then 25 Second
  • Patient with asthma or chronic obstructive pulmonary disease.

结局指标

主要结局

1.To Assess the ratio of PaO2 to fraction of inspired oxygen (PaO2/FiO2)

时间窗: 48 hours

次要结局

  • 1. To Assess PaO2, PaCO2 and surgical exposure.(2. To Assess the postoperative Inflammatory parameters like Body Temperature, Heart rate, Total leukocyte count, C reactive protein.)

研究者

发起方
Dr Prashant K Desai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Prashant K Desai

Kidwai Memorial Institute of Oncology, Bangalore

研究点 (1)

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