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CTRI Number  CTRI/2023/12/060459 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 08/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   I gel in paediatric cardiac surgery 
Scientific Title of Study   Congenital Cardiac surgery with cardiopulmonary bypass using supraglottic airway in pediatric patient: A new horizon 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alok Kumar 
Designation  Prof 
Affiliation  Armed Forces Medical College 
Address  Dept of Anaesthesia, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  8146044104  
Fax    
Email  mipayal07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Alok Kumar 
Designation  Prof 
Affiliation  Armed Forces Medical College 
Address  Dept of Anaesthesia, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  8146044104  
Fax    
Email  mipayal07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Alok Kumar 
Designation  Prof 
Affiliation  Armed Forces Medical College 
Address  Dept of Anaesthesia, Armed Forces Medical College, Pune

Pune
MAHARASHTRA
411040
India 
Phone  8146044104  
Fax    
Email  mipayal07@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Armed Forces Medical college 
Address  Dept of Anaesthesia , Armed Forces Medial College, Pune-411040 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Alok Kumar  Army institute of Cardiothoracic centre  Operation theatre, Dept of anaesthesia, Armed forces Medical College, Pune
Pune
MAHARASHTRA 
8146044104

mipayal07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committe, Armed Forces Medical College, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  NA 
Intervention  supraglottic airway  use of supraglottic airway for maintenance of airway during anaesthesia in paediatric cardiac surgery; in the intraoperative period inside operation theatre. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  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  
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.  Intraoperative and immediate postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   11/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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.

 

 
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