| CTRI Number |
CTRI/2018/01/011136 [Registered on: 04/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing LMA Supreme with LMA Unique in children to find out which is better for surgical cases. |
|
Scientific Title of Study
|
A Randomized Trial Comparing The Laryngeal Mask Airway Supremeâ„¢ With The Laryngeal Mask Airway Uniqueâ„¢ In Anaesthetised And Paralysed Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lt Col Amit Dua |
| Designation |
Assistant professor |
| Affiliation |
Army Hospital research and referral, New Delhi |
| Address |
Department of Anaesthesiology
Army Hospital R&R , New Delhi
pin- 110010
Department of Anaesthesiology
Armed Forces Medical College (A.F.M.C)
Wanowarie
Pune - 411040
New Delhi
DELHI
110010
India |
| Phone |
7767834036 |
| Fax |
|
| Email |
amitduadua@yahoo.om |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col Amit Dua |
| Designation |
Assistant Professor, Department of Anaesthesiology, AH (R&R),New Delhi |
| Affiliation |
Army hospital research and referral, New Delhi |
| Address |
Assistant Professor
Department of Anaesthesiology
Army hospital research and referral. AH (R&R). New Delhi
New Delhi
DELHI
110010
India |
| Phone |
7767834036 |
| Fax |
|
| Email |
amitduadua@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipin Sukumaran |
| Designation |
Graded Specialist (Anaesthesiology), 168MH, Kupwara., Jammu and Kashmir. |
| Affiliation |
Armed Forces Medical College (A.F.M.C) |
| Address |
Graded Specialist
Anaesthesiology
Kupwara
Jammu and Kashmir
pin 193222
Jammu
JAMMU & KASHMIR
193222
India |
| Phone |
7420065560 |
| Fax |
|
| Email |
vipinsukumaran83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Foces Medical College (A.F.M.C) . Wanowarie, Pune |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology
Armed Forces Medical College (A.F.M.C)
Wanowarie
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 |
| Lt Col Amit Dua |
Tertiary care hospital |
Department Of Anaesthesiology
Command Hospital southern Command
Pune - 411040
Pune
MAHARASHTRA |
7767834036
amitduadua@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research cell and Institutional Ethics Committee, A.F.M.C, Pune |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
1. Children undergoing elective day surgeries where a size 1.5,2 and 2.5 of LMA Unique will normally be used for airway maintenance.
2. ASA grade I and II.
3. Age between 6 months and 8 years
, (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LMA Supreme size 1.5 , 2 and 2.5 |
Laryngeal mask airways (LMA) are supraglottic airway devices (SGA) which have become a standard fixture in airway management, filling the niche between the facemask and tracheal tube in terms of both anatomical position and degree of invasiveness. These devices sit outside the trachea but provide a hands free means of achieving a gas-tight airway.The laryngeal mask airway Supreme is a new single use second generation laryngeal mask airway with structural modifications, which include a curved and rigid airway tubing, a channel for passage of a gastric drain tube and a larger cuff made of polyvinyl chloride. The LMA Supreme as well as LMA Unique are now available in all paediatric sizes 1, 1.5, 2 and 2.5. |
| Comparator Agent |
LMA Unique 1.5, 2 and 2.5 |
. Laryngeal mask airways (LMA) are supraglottic airway devices (SGA) which have become a standard fixture in airway management, filling the niche between the facemask and tracheal tube in terms of both anatomical position and degree of invasiveness. These devices sit outside the trachea but provide a hands free means of achieving a gas-tight airway.
2. Laryngeal mask airways have evolved from LMA Classic and LMA Unique (first generation) to LMA Proseal and LMA Supreme (second generation). Laryngeal mask airway (LMA) Classic is an established supraglottic airway (SGA) used in children as well as adults. LMA Unique is a similar form of supraglottic airway, but for single use only. The laryngeal mask airway Unique has played an integral role in airway management for children
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Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
STUDY POPULATION
Children undergoing elective day surgeries where a size 1.5,2 and 2.5 of LMA Unique will normally be used for airway maintenance will be enrolled in the study
CRITERIA FOR SELECTION OF SUBJECTS
1. ASA grade I and II.
2. Age between 6 months and 8 years
|
|
| ExclusionCriteria |
| Details |
CRITERIA FOR EXCLUSION
1. Patients with acute respiratory illness (cough, fever and rhinorrhea) on the day of anaesthesia
2. Anticipated difficult airway
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Primary outcome: Airway leak pressure.
2. Secondary outcome:
a. The ease of insertion
b. Insertion success rate
c. Ease of gastric tube placement (in LMA Supreme)
d. Quality of airway patency
e. Complications
|
Airway leak pressure will me measured after the successful insertion of the device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Secondary outcome:
a. The ease of insertion
b. Insertion success rate
c. Ease of gastric tube placement (in LMA Supreme)
d. Quality of airway patency
e. Complications
|
Time of successful insertion is frm th removal of face mask to the first capnography upstroke |
|
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Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2015 |
| Date of Study Completion (India) |
22/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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)?
|
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Brief Summary
|
SUMMARY In this study Laryngeal mask airway (LMA) Supreme was compared with LMA Unique in anaesthetised and paralysed children.The overall clinical performance of LMA Supreme was found superior to LMA Unique. LMA supreme was compared with LMA Unique in various parameters like airway leak pressure, ease of insertion, no of attempts and complications etc. It was found that LMA Supreme has a better ease of insertion less complications and larger airway leak pressure compared to LMA Unique. |