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临床试验/NCT03234582
NCT03234582Unknown不适用

Comparison of Right Ventricular Outflow Tract Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing Tetralogy of Fallot Repair

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Comparison of right ventricular outflow tract gradient under anaesthesia with post-operative gradient in patients undergoing tetralogy of Fallot repair

研究概览

简要总结

The primary objective of the study will be to compare intraoperative post TOF repair RVOT gradient under two different anaesthetic depths. Secondary objectives will be to follow up change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes used post-operatively by vasoactive- inotropic score (VIS), RV functions at discharge from ICU and at 1 month follow- up

详细描述

After completion of the TOF repair and rewarming to normothermia, all the patients will be assessed by TEE for adequacy of repair and separated from the cardiopulmonary bypass using vasopressors and inotropes. The choice of vasoactive and inotropic agents will be as per the requirement to maintain stable hemodynamics of the patients. Post bypass sevoflurane 1% end tidal concentration (0.5 MAC) will be used in all the patients. RV pressure and gradients across RVOT will be measured directly by placing a 23 gauge needle into the RV and pulmonary artery, and also by TEE using Bernoulli's equation by placing continuous Doppler across tricuspid regurgitation jet and RVOT, as is being routinely done for patients undergoing TOF repair. In addition, velocity time integral (VTI) across left ventricular outflow tract (LVOT) will also be recorded along with other hemodynamic parameters such as HR, SBP, DBP, MAP and SpO2. Subsequently, these measurements will be repeated again after increasing the sevoflurane to 2% end tidal concentration (1 MAC) and allowing the patients to stabilise on this new concentration for 5 minutes while maintaining systemic pressure within a range of 5% of the previous value. Normocarbia (EtCO2 30-35 mmHg) will be maintained during these measurements by adequate minute ventilation.

Following the surgery, all the patients will be shifted to cardio-surgical ICU and will be extubated once they meet the extubation criteria. Post-operative RVOT pressure gradient and RV functions will be assessed by trans-thoracic echocardiography at 2 hrs post extubation, at discharge from ICU and after 1 month of surgery on first follow-up. RV functions on echocardiography will be assessed using TAPSE (Tricuspid annular plane systolic excursion) and fractional RV area change during systole. The duration of post-operative mechanical ventilation, vasoactive inotropic score (VIS), PaO2/FiO2 ratio till discharge from ICU and any morbidity or adverse outcome during hospital stay will be noted.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
6 Months 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All the children between 6 months to 16 years of age undergoing TOF repair will be included in the study.

排除标准

  • TOF patients with pulmonary atresia, atrioventricular canal defects and where consent is refused will be excluded from the study.

结局指标

主要结局

Comparison of right ventricular outflow tract gradient under anaesthesia with post-operative gradient in patients undergoing tetralogy of Fallot repair

时间窗: 15 minutes

The primary objective of the study will be to compare intra-operative post TOF repair RVOT gradient under two different anaesthetic depths

次要结局

  • Comparison of change in right ventricular outflow tract gradient post-operatively in patients undergoing tetralogy of Fallot repair(1 month)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Dheemta Toshkhani

Junior Resident

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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