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临床试验/CTRI/2024/09/074089
CTRI/2024/09/074089尚未招募不适用

The relationship of left atrial appendage peak systolic velocity with the incidence of postoperative atrial fibrillation in patients undergoing cardiac surgery - A prospective observational study

未提供1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年10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
105
试验地点
1
主要终点
The incidence of post operative atrial fibrillation.

研究概览

简要总结

The incidence of POAF is a common occurrence following cardiac surgery therefore, early identification of its occurrence would warrant health care providers to be proactive in treating the common causes of atrial fibrillation (AF) in the immediate post operative period. Since no other study as far as we have searched has worked on studying the correlation between peak systolic velocity of left atrial appendage (LAA) and the incidence of POAF, this study will be conducted.

  1. Methodology of measuring Primary objective:

  2. A 6VT TEE probe will be inserted and echocardiography images will be obtained with GE Vivid E95 Echocardiography machine (GE Vingmed Ultrasound, Horten, Norway) according to the surgical procedure with the aid of standard TEE guidelines.

  3. In mid-esophageal two chamber view (ME 2C) view, the LAA will be identified as a claw- like structure arising from the left atrium. Pulsed wave doppler (PWD) will then be applied with the sample volume taken at one‐third length of the LAA from its base11. The peak positive wave will be measured as peak systolic velocity which is synonymous with LAA peak emptying velocity . Three consecutive values will be taken and averaged. Readings will be taken before sternotomy and after weaning off CPB.

  4. Patients will be followed up in ICU and till the day of discharge. AF will be diagnosed upon the detection of abnormality in rhythm electrocardiogram (ECG), that is sustained for a minimum of 30 seconds and characterised by sustained arrhythmia, absent P waves, irregular R-R intervals and different intervals between atrial contractions (cycle < 200 ms).

  5. Statistical analysis:

    • Receiver-operating characteristic (ROC) analysis will be used to determine optimal cutoff valuesof continuous variables for prediction of POAF.
  • The area under the ROC curve will be used to quantify the ability of the PSV of LAA to predictincidence of POAF accurately.
  • Regression analysis will be used for all possible confounding factors and to assess interaction between variables for assessment of POAF.

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

  • • Scheduled to undergo cardiac surgery under cardiopulmonary bypass • In Sinus rhythm in the preoperative period.

排除标准

  • • Patient refusal for study • Preexisting AF • Previous procedure involving LAA • Emergency / redo surgery • Contraindication for TEE.

结局指标

主要结局

The incidence of post operative atrial fibrillation.

时间窗: Baseline ECG and ECG monitoring throughout the period of ICU stay

次要结局

  • Correlation of left atrial diameter, peak systolic velocity of mitral valve, average E, e’, E/A, E/e’, a’, LAVI & VIS with peak systolic velocity of LAA in the occurrence of post operative atrial fibrillation.(Baseline ECG before the surgery & ECG monitoring throughout the period of ICU stay)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Grace Aiswarya Jasmin David

All India institute of medical science, Bhubaneswar, Odisha

研究点 (1)

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