| CTRI Number |
CTRI/2022/04/042330 [Registered on: 29/04/2022] Trial Registered Prospectively |
| Last Modified On: |
20/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two Laryngeal Mask Airways in paediatric patients under controlled ventilation |
|
Scientific Title of Study
|
Comparison between Blockbuster Laryngeal Mask Airway and Proseal Laryngeal Mask Airway in paediatric patients under controlled ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaista Parveen |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education And Research Kolkata |
| Address |
Main OT Complex
Main Block ( 3rd Floor )
Department of Anaesthesiology
IPGMER SSKM Hospital
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9899625036 |
| Fax |
|
| Email |
shaistap91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjib Bhattacharyya |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education And Research Kolkata |
| Address |
Main OT Complex
Main Block, 3rd Floor
Department of Anaesthesiology
IPGMER Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433508030 |
| Fax |
|
| Email |
bhattach1@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chiranjib Bhattacharyya |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education And Research Kolkata |
| Address |
Main OT Complex
Main Block, 3rd Floor
Department of Anaesthesiology
IPGMER Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433508030 |
| Fax |
|
| Email |
bhattach1@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
IPGMER Kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology IPGMER Kolkata |
| Address |
244 AJC Bose Road Kolkata
700020 |
| 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 |
| Dr Chiranjib Bhattacharyya |
IPGMER SSKM Hospital Kolkata |
Main OT Complex
Main Block ( 3rd Floor )
Department of Anaesthesiology
IPGMER SSKM Hospital
244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL |
9433508030
bhattach1@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
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 |
| Intervention |
Insertion of Blockbuster LMA |
Insertion of Blockbuster LMA in 2-10 years age group paediatric patients(ASA class I and II) for short surgical procedures lasting approx 1-2 hour under GA with muscle relaxation and controlled ventilation. |
| Comparator Agent |
Insertion of Proseal LMA |
Insertion of Proseal LMA in 2-10 years age group paediatric patients (ASA class I and II) for short surgical procedures lasting approx 1-2 hour under GA with muscle relaxation and controlled ventilation. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA Class I and II
Having no congenital anomaly
Posted for elective non laparoscopic surgery under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
Parental refusal
Having congenital anomaly, airway difficulty
Known cardiovaascular,hepatic, pulmonary, renal,neurological, endocrinological diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the oropharyngeal leak pressure of the two SGA devices |
Following placement of the devices in the airway and induction of GA with muscle relaxation under controlled ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of successful placement of the respective LMA |
During Induction of anaesthesia |
| Insertion time for the two devices |
During insertion of the devices |
| Visualization of glottis through the SGA by fibreoptic scope |
After Insertion of the devices |
| Ease of gastric tube insertion |
Following placement of the devices |
| Incidence of post operative sore throat |
24 hour post operative period |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/07/2022 |
| 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="1"
Months="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will assess the safety and efficacy of Blockbuster LMA in airway management in comparison to Proseal LMA for elective non laparoscopic surgery in paediatric patients under General Anaesthesia with muscle relaxation and controlled ventilation |