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临床试验/CTRI/2024/11/076983
CTRI/2024/11/076983尚未招募不适用

A Study To Establish The Efficacy Of Pressure Volume Loop Spirometry Technique For Endotracheal Tube Cuff Inflation For Patients Posted For Laparoscopic Surgeries Under General Anaesthesia.

Dr Priyaadharshini T1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To evaluate if any increase in ET tube cuff volume is warranted to avoid air leak around the cuff due to rise in peak inspiratory pressure after peritoneal CO2 insufflation for laparoscopic procedures under general anaesthesia by recording pressure volume loop spirometry curve on anaesthesia workstation.

研究概览

简要总结

Endotracheal intubation is routinely performed during general anaesthesia. When the cuff on the ETT is inflated, it is crucial to maintain a proper cuff pressure because both high or low cuff pressure can lead to serious adverse events. Either overinflation causes ischaemic changes or underinflation of the cuff may lead to risk of aspiration. Pressure volume loop (PV-L) is a real time continuous pulmonary graph incorporated in anaesthesia workstation. It has been shown that Pressure volume loop (PV -L) provides adequate seal. The advantage of using PV -L than other methods is that it requires low volume of air & less cuff pressure compared to standard techniques of cuff inflation. Changes in respiratory parameters will be recorded during pre insufflation, following 2 mins of pneumoperitoneum with the help of  PVL spirometry by evaluating the presence of air leak around the ETT cuff and to ensure that it provides adequate seal in patients undergoing for laparoscopic surgeries.

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 undergoing elective laparoscopic surgeries
  • Age between 18 to 60 years.

排除标准

  • If peak airway pressure exceeds 35cm H2O during CO2 insufflation of peritoneum to avoid barotrauma,
  • If the EtCO2 rise above 40mmHg,
  • H/o Asthma,
  • Chronic lung diseases,
  • Preoperative cough, sore throat , hoarseness of voice.
  • Difficult airway
  • Patient who refuse consent
  • Patients with full stomach , those who requires rapid sequence intubation.
  • Pregnant women.

结局指标

主要结局

To evaluate if any increase in ET tube cuff volume is warranted to avoid air leak around the cuff due to rise in peak inspiratory pressure after peritoneal CO2 insufflation for laparoscopic procedures under general anaesthesia by recording pressure volume loop spirometry curve on anaesthesia workstation.

时间窗: 1.Immediately after Intubation 2. After initiation of pneumoperitoneum of abdomen with carbondioxide during laparoscopic surgery.

次要结局

  • To study the incidence of cuff related complications such as sore throat, cough / hoarseness of voice post extubation.(After Extubation)

研究者

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

Dr Priyaadharshini T

Sri Narayani Hospital And Research Centre

研究点 (1)

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