| 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
|
|
|
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
|
|
|
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
|
|
|
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. |