| CTRI Number |
CTRI/2022/04/042024 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
21/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study of Laryngoscope guided and Blind insertion techniques of Laryngeal Mask Airway Proseal in Children |
|
Scientific Title of Study
|
A Comparative study of Laryngoscope guided and Blind insertion techniques of Laryngeal Mask Airway Proseal in Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Goyat |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
C-74 Third Floor Naraina Vihar
New Delhi
Department of Anesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
New Delhi
DELHI
110028
India |
| Phone |
7988628124 |
| Fax |
|
| Email |
dramitgoyat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Goyat |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
Department of Anesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7988628124 |
| Fax |
|
| Email |
dramitgoyat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Goyat |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care
VMMC and Safdarjung Hospital
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7988628124 |
| Fax |
|
| Email |
dramitgoyat@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Ansari Nagar New Delhi 110029 |
| 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 Jeetendra Kumar Bajaj |
VMMC and Safdarjung Hospital |
Department of Anesthesis and Critical Care, Main OT building, Ground Floor, Room No- 10
New Delhi
DELHI |
9810465070
jeetendrabajaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing of Laryngoscope guided and blind technique |
In terms of Oropharyngeal Leak Pressure, Fiberoptic position scoring, Ease of insertion scoring, Heamodyanamic parameters, trauma ,post op adverse events. |
| Intervention |
Inserting of Proseal Laryngeal Mask Airway |
In one group Proseal Laryngeal Mask Airway will be inserted blindly, in other group Laryngoscope guided insertion will be there for securing the airway in General Anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
The ASA 1/2 children of either gender in the age group of 2-12 years old scheduled for surgery under General Anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway, restricted mouth opening, recent upper respiratory tract infection, increased risk of regurgitation,aspiration, hiatus hernia, cervical spine disease, head and neck surgeries, syndromes affecting airway. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal Leak Pressure. |
At 5 mins after insertion of LMA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal Leak Pressure, Fiberoptic Position Scoring,Ease of insertion Scoring, Heamodyanamic Parameters, any trauma, postoperative adverse events |
At Baseline, before insertion of PLMA,at 1,3 and 5 mins after insertion of LMA |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
22/04/2022 |
| 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 Yet Recruiting |
| 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
|
A prospective comparative interventional randomised study comparing Laryngoscope guided and blind insertion technique of Laryngeal Mask Airway Proseal in children of age 2-12 years undergoing elective surgery under General Anesthesia in total 160 children ,80 in each group. The results will be compared in terms of Oropharyngeal Leak Pressure, Fiberoptic Position scoring , Ease of insertion, Heamodyanmic Parameters, trauma (to lip, teeth, gums, tongue and oral cavity) , and postoperative adverse events (like sore throat ,hoarseness of voice, dysphasia) |