| CTRI Number |
CTRI/2022/11/047791 [Registered on: 30/11/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Insertion Of ProSeal Airway Device With Introducer Tool With Stylet And Without Stylet |
|
Scientific Title of Study
|
Comparison Of ProSeal Laryngeal Mask Airway Placement Using Introducer Tool With And Without Stylet In Paediatric Patients Posted For Elective Surgery Under General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Pandey |
| Designation |
Post-graduate Resident |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
137C, Flat no 6 gali no 39 Arjun nagar Safdurjung enclave New Delhi 110029
Department of Anaesthesiology
ABVIMS and Dr RML Hospital
Baba Kharak Singh MArg
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9205415492 |
| Fax |
|
| Email |
neehapaandey26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Arora |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Department of Anaesthesiology
ABVIMS and Dr RML Hospital
Baba Kharak Singh Marg
New Delhi
Department of Anaesthesiology
ABVIMS and Dr RML Hospital
Baba Kharak Singh MArg
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namita Arora |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
Department of Anaesthesiology
ABVIMS and Dr RML Hospital
Baba Kharak Singh Marg
New Delhi
Department of Anaesthesiology
ABVIMS and Dr RML Hospital
Baba Kharak Singh MArg
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
ABVIMS and Dr RML Hospital
New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr. NAMITA ARORA |
| Address |
Professor
Department Of Anaesthesiology
ABVIMS and Dr RML Hospital
New Delhi |
| Type of Sponsor |
Other [Professor] |
|
|
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 Neha Pandey |
ABVIMS And Dr. Ram Manohar Lohia Hospital |
Department Of Anaesthesiology
Baba Kharak Singh Marg
New Delhi
New Delhi
DELHI |
9205415492
neehapaandey26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS and Dr.RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Paediatric patients posted for elective surgery under General Anaesthesia |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Status I and II
2. Elective Surgery under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Anticipated Difficult Airway
2. Airway related surgery, posttonsillectomy
3. Emergency Surgery
4. Children with cardio-respiratory disease, URTI, Hiatus Hernia, Full stomach, History of convulsions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fibreoptic Bronchoscopic grading of PLMA placement |
Realtime |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of attempts for insertion
2. Total time taken for successful insertion(seconds)
3. Hemodynamic variables MAP, HR
4. Postoperative adverse effects Dysphagia, Dysphonia, Sore throat |
Intra operative and Post operative |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
07/12/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients, who fulfill the inclusion criteria, will participate in the study. They will be computerised randomisation where they will be divided into two groups IT - 65 patients and ST - 65 patients. In IT group, the PLMA will be inserted with an introducer tool, followed by clinical assessment and assessment by fibreoptic bronchoscope. In ST group, the PLMA will be inserted using a stylet, followed by clinical assessment and assessment with fibreoptic bronchoscope. Based on a five-point scale by CHen et al, grading of glottic view on fibreoptic bronchoscopy will be done. Grade and 4 are acceptable placement, whereas grades 0,1,2 are not acceptable and require endotracheal tube intubation. |