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临床试验/CTRI/2024/04/065945
CTRI/2024/04/065945已完成不适用

Comparison of flexible videoendoscope, video laryngoscopy assisted or blind transoesophageal echocardiography probe insertion on hemodynamic parameters in adults undergoing cardiac surgery: A randomized controlled study

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年5月13日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
TEE probe insertion success

研究概览

简要总结

Transoesophageal echocardiography (TEE) is an invaluable tool in the cardiac anesthesia armamentarium and used to assess cardiac structure and function. Requirement of TEE is critical in every step during perioperative period, beginning from the preoperative confirmation of diagnosis, surgical decision making, assessment of ventricular function and ensuring adequate postoperative repair. Conventionally, TEE probe is inserted blindly. However, repeated attempt of conventional blind insertion technique may cause oropharyngeal laceration, oesophageal tear, gastric injury leading to gastrointestinal bleeding, and dysphagia.

The incidence of major complications associated with TEE probe is very low around 0.08% (1:1300 examination), but the probability of death is high, almost >40% if any such major complication occurs. Hence, sometimes jaw thrust, and/or conventional laryngoscope is used to aid the insertion of the TEE probe. Recently, the use of video laryngoscopy for insertion of the TEE probe has found to be helpful in decreasing the incidence of trauma. Though video laryngoscope is a useful technique compared to blind insertion, the incidence of hemodynamic perturbations may be similar to jaw thrust manoeuvre, and conventional laryngoscope assisted insertion.

Flexible videoendoscope has emerged as an important component of difficult airway equipment. No previous studies have used flexible videoendoscope assisted insertion of the TEE probe. It may be possible that use of a flexible videoendoscope for assisting TEE probe insertion may provide better performance characteristics as compared to a video laryngoscope in terms of a wider field of view, allowing both hands of the operator for oral manipulation and TEE probe insertion along with less hemodynamic perturbations; but with a similar first pass success rate.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • undergoing elective cardiac surgery and requiring TEE evaluation will be included.

排除标准

  • Patients with known or anticipated difficult airway or requiring 2 attempt of for intubation, nasal pathology or deviated nasal septum and those in whom the TEE probe cannot be used will be excluded from the study.

结局指标

主要结局

TEE probe insertion success

时间窗: success at first attempt

次要结局

  • operator satisfaction(at the time of insertion)
  • time to insertion(at the time of insertion)
  • number of attempts required to successfully insert the TEE probe(at the time of insertion)
  • hemodynamic variation(5 minutes of TEE probe insertion)
  • incidence of complications related to TEE probe insertion(at the end of surgery)

研究者

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

Devishree Das

AIIMS, Bhubaneswar

研究点 (1)

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