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临床试验/CTRI/2025/10/096386
CTRI/2025/10/096386尚未招募不适用

Effect of transesophageal echocardiographic probe placement and manipulation on endotracheal cuff pressure in adult patients undergoing cardiac surgery on cardiopulmonary bypass

Vardhman Mahavir medical college and Safdarjung hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月2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
100
试验地点
1
主要终点
Endotracheal tube cuff pressure, mean arterial pressure and tracheal perfusion pressure

研究概览

简要总结

this study is a prospective observational study to determine effects of transesophageal echocardiographic probe insertion placement and its manipulation on endotracheal cuff pressure in adults aged 18-65 years who are undergoing cardiac surgery on cardiopulmonary bypass. The primary outcome is measuring endotracheal tube cuff pressure, mean arterial pressure and tracheal perfusion pressure before transesophageal echocardiographic probe insertion, during insertion, 5 mins after  transesophageal echocardiographic probe insertion, during transesophageal echocardiographic probe examination, after transesophageal echocardiographic probe examination, on cardiopulmonary bypass at maximal hypothermia, after rewarming and while probe removal.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Adult patients aged 18-65 years fulfilling the criteria of American Society of Anesthiolologists grade 2 and 3 undergoing elective cardiac surgery on cardiopulmonary bypass under mild to moderate hypothermia.

排除标准

  • Patients with difficult airway contraindicating TEE probe placement
  • Patients with preexisting tracheal pathology
  • Patients with oesophageal pathology or previous oesophageal surgeries contraindicating probe insertion.

结局指标

主要结局

Endotracheal tube cuff pressure, mean arterial pressure and tracheal perfusion pressure

时间窗: T0-before TEE insertion baseline , T1-during TEE insertion ,T2- 5min after TEE probe insertion,T3-during TEE examination,T4- after completing TEE examination ,T5- on CPB at maximum hypothermia, T6- after complete rewarming and T7-while removing the probe

次要结局

  • Peak airway pressure & mean airway pressure(T0-before TEE insertion baseline , T1-during TEE insertion ,T2- 5min after TEE probe insertion,T3-during TEE examination,T4- after completing TEE examination ,T5- on CPB at maximum hypothermia, T6- after complete rewarming & T7-while removing the probe)
  • Hemofiltration volume on CPB, hemodilution , hematocrit and electrolyte changes
  • Incidence of postoperative complications like sore throat, hoarseness of voice, stridor or reintubation(Postoperatively)

研究者

发起方
Vardhman Mahavir medical college and Safdarjung hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Saumyaa Vishwaani

Vardhaman Mahavir Medical College and Safdarjung Hospital

研究点 (1)

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