跳至主要内容
临床试验/CTRI/2023/12/060801
CTRI/2023/12/060801尚未招募不适用

Comparison of the post-operative ultrasonographic assessment of diaphragmatic function in robotic assisted laparoscopic surgeries and laparotomies-a prospective observational study

All India institute of medical sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
For improvement in medical sciences

研究概览

简要总结

Patient will be assessed preoperatively before induction using a GE Healthcare  ultrasound (M-mode) to examine the DE and TF of both hemidiaphragms respectively in a semi recumbent position with the head of the bed tilted at 45 degrees. The diaphragm excursion refers to the movement of diaphragm during breathing assessed by ultrasound by placing a linear probe over the lower intercostals space in the anterior axillary line measured during a quiet breathing. The ultrasound beam was directed to the diaphragm domes at an angle greater than 70 degrees and M-mode tracing was initiated. DE is measured as the vertical distance from the baseline to the highest point of inspiration at quiet breathing. Six measurements from both the hemidiaphragms will be obtained and their mean will be used in data analysis. Where as The diaphragm thickness is measured (in the zone of apposition of the diaphragm and rib cage) in the mid-axiallary line (longitudinally) between the eighth and tenth intercostals space, using a  high frequency linear probe. the diaphragm will be viewed as a three layered structure sandwiched between  the two ecogenic layer of pleura and peritoneum. Using the M-mode function, the thickness of the diaphragm at end inspiration (DTI) and end expiration (DTE) will be measured. TF is given by the formula:

TF  = DTI – DTE / DTE   * 100

TF of both the hemidiaphragm was taken into account and there mean was used for data analysis. Intra-operative neuromuscular monitoring with NMT for TOF ratio will be monitored and only when TOF >0.9 patient will be extubated so as no neuromuscular residual blockade persist due to general anaesthesia.

Post operatively patient will be examined in PACU after one hour of successful extubation and same technique will be used as described above for post operative DE and TF measurement and their findings will be compared and analyzed for any residual paralysis or dysfunction of diaphragm post RALS and laparotomies.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All adult patients (above 18 years), ASA Physical Status I-III, undergoing RALS in steep Trendelenburg position or laparotomy of estimated duration more than 4 hours.

排除标准

  • Age less than 18 years Diaphragmatic hernia, ascites,stroke,pregnancy Known case of neuromuscular disorder Phrenic nerve injury Post op mechanical ventilation Not giving consent Neuromuscular transmission monitoring not possible.

结局指标

主要结局

For improvement in medical sciences

时间窗: post operatively after half an hour of procedure

The most probable outcome from this study is decrease in diaphragm function post RALS due to steep Trendelenburg and this in future could help in risk stratification in these patients

时间窗: post operatively after half an hour of procedure

次要结局

未报告次要终点

研究者

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

Deepika Biswas

All India institute of medical sciences,Jodhpur

研究点 (1)

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