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临床试验/CTRI/2023/12/060459
CTRI/2023/12/060459进行中(未招募)4 期

Congenital Cardiac surgery with cardiopulmonary bypass using supraglottic airway in pediatric patient: A new horizon

Armed Forces Medical college1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年12月11日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
10
试验地点
1
主要终点
The primary objective was to determine the viability of I-Gel for induction and maintenance of anaesthesia in children undergoing surgery for acyanotic congenital heart disease with cardiopulmonary bypass. The secondary objective was to achieve smoother and faster extubation with lower doses of opioid utilisation and better hemodynamic control in children undergoing surgery for acyanotic congenital heart disease with cardiopulmonary bypass.

研究概览

简要总结

Congenital heart defects like atrial septal defects have proven to be a leading cause of mortality and chronic diseases in the pediatric age group and are often regarded as benign heart lesions. These defects can be small, medium or large and have hemodynamic and electrophysiological consequences. Closure of these defects with cardiac surgery utilizing cardiopulmonary bypass (CPB) remains the standard treatment and is associated with less morbidity and mortality with advancing medical sciences. Laryngoscopy and endotracheal intubation produce reflex sympathetic stimulation and are associated with raised levels of plasma catecholamines, hypertension, tachycardia, myocardial ischemia, depression of myocardial contractility, ventricular arrhythmias, and intracranial hypertension.

Laryngeal mask airways have had a significant impact on the practice of anaesthesia, management of the difficult airway and cardiopulmonary resuscitation in children and neonates. Newer supraglottic airway devices have evolved over time and apart from providing a secure airway they ensure hemodynamic stability, which is an essential requirement for patients undergoing cardiac surgery. I-gel (second-generation supraglottic airway device), is a single-use device which has been designed to create a non-inflatable, anatomical seal of the pharyngeal, laryngeal and peri laryngeal structures while avoiding compression trauma. It facilitates insertion, minimizes tissue compression, maintains the stability of position after placement and separates the gastrointestinal and respiratory tracts.  I-gel is very easy to insert and demands no learning curve for acquiring a high success insertion rate.

Nowadays cardiac surgery has faced a growing interest for fast extubation and early discharge from the intensive care unit (ICU) after the operation. While large doses of fentanyl have been used to assure hemodynamic stability during cardiac surgery, they invariably tend to prolong mechanical ventilation in the ICU. The use of a supraglottic airway along with neuraxial analgesia allows smoother extubation with lower doses of opioid utilisation and better hemodynamic control.

I-gel appears to be safe for paediatric management but no literature exists on its use while conducting a major open-heart surgery under CPB in the pediatric age group. The objective of this  study is to evaluate the feasibility of I-Gel  for induction and maintenance of anaesthesia in children undergoing surgery for acyanotic congenital heart disease with cardiopulmonary bypass.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Children aged less than 18 years undergoing surgery for acyanotic congenital heart disease requiring CPB with Mallampatti scoring of Gd 1 & 2 and not having any F/S/O URTI in the last 14 days.

排除标准

  • All patients with difficult airway, history of previous cardiac surgery, patients utilizing preoperative extracorporeal life support, patients who underwent surgery without cardioplegic arrest, emergency surgery, a history of reactive airway disease or gastroesophageal reflux and, morbid obesity.

结局指标

主要结局

The primary objective was to determine the viability of I-Gel for induction and maintenance of anaesthesia in children undergoing surgery for acyanotic congenital heart disease with cardiopulmonary bypass. The secondary objective was to achieve smoother and faster extubation with lower doses of opioid utilisation and better hemodynamic control in children undergoing surgery for acyanotic congenital heart disease with cardiopulmonary bypass.

时间窗: Intraoperative and immediate postoperative period

次要结局

  • The secondary objective was to achieve smoother and faster extubation with lower doses of opioid utilisation and better hemodynamic control in children undergoing surgery for acyanotic congenital heart disease with cardiopulmonary bypass.(immediate postoperative)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Alok Kumar

Armed Forces Medical College

研究点 (1)

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