| CTRI Number |
CTRI/2018/04/013102 [Registered on: 09/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different airway devices in children undergoing elective surgery |
|
Scientific Title of Study
|
A Comparision Of The Performance Characteristics Of I-Gel,Laryngeal Mask Airway Supreme And Proseal Laryngeal Mask Airway in Children Undergoing Elective Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrita |
| Designation |
Senior Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital. New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9958063996 |
| Fax |
|
| Email |
amrita18october@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Talwar |
| Designation |
Consultant and Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital Delhi |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital. New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita |
| Designation |
Senior Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958063996 |
| Fax |
|
| Email |
amrita18october@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi-110029 India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital. 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 AMRITA |
Vardhman Mahavir Medical College and Safdarjung Hospital. New Delhi-110029 |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital. New DELHI-110029
New Delhi
DELHI |
9958063996
amrita18october@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
AGE 3-10 YEARS ASA GRADE 1 AND 11 WITH NORMAL AIRWAY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I-GEL |
The standard anaesthetic protocol consisted of an inhalational induction with 8%sevoflurane in 50%oxygen and nitrous oxide followed by intravenous access(IV)and inj fentanyl 2ug/kg IV and inj propofol 1mg/kg IV administered if required. After checking for manual ventilation inj vecuronium 0.1mg/kg given and I-gel inserted after 3 minutes of IPPV. |
| Intervention |
LMA SUPREME |
The standard anaesthetic protocol consisted of an inhalational induction with 8% sevoflurane in 50% oxygen and nitrous oxide followed by intravenous access(IV)and inj fentanyl 2ug/kg and inj propofol 1mg/kg administered if required. After checking for manual ventilation inj vecuronium 0.1mg/kg given and LMA Supreme inserted after 3minutes of IPPV and cuff was inflated till intracuff pressure of 60cm of water is achieved. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PROSEAL LMA |
The standard anaesthetic protocol consisted of an inhalational induction with 8% sevoflurane in 50% oxygen and nitrous oxide followed by intravenous access(IV) and inj fentanyl2ug/kg IV and inj Propofol 1mg/kg IV if required. After checking for manual ventilation inj vecuronium 0.1mg/kg given and Proseal LMA inserted after 3minutes of IPPV and cuff was inflated till intracuff pressure of 60 cm of water is achieved. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE1 &II, NORMAL AIRWAY UNDERGOING ELECTIVE SURGERY |
|
| ExclusionCriteria |
| Details |
WEIGHT <5KG,ACTIVE UPPER RESPIRATORY TRACT INFECTION, PATIENTS WITH RISK OF GASTROESOPHAGEAL REGURGITATION |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare airway leak pressures between Proseal LMA, LMA Supreme and I-gel in patients undergoing elective surgeries |
After insertion of supraglottic airway device. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare insertion characteristics and fibreoptic assessment of supraglottic airway devices in pediatric patients undergoing elective surgeries |
At the time of insertion and after insertion of device |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2015 |
| Date of Study Completion (India) |
20/01/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1) To compare airway leak pressures between Proseal LMA, LMA Supreme and I-gel in pediatric patients undergoing elective surgeries. 2) To compare insertion characteristics and fibreoptic assessment of the SGAs in pediatric patients undergoing elective surgeries. |