| CTRI Number |
CTRI/2018/04/013297 [Registered on: 16/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
14/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of insertion characteristics of LMA ProSeal ( a type of airway device ) using different techniques in children |
|
Scientific Title of Study
|
Comparative evaluation of insertion characteristics of LMA ProSeal using different techniques in the paediatric age group |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suman Tiwari |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhaman MahavirMedical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9971636443 |
| Fax |
|
| Email |
tiwari.suman2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Seth |
| Designation |
Consultant and Professor |
| Affiliation |
Vardhaman MahavirMedical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9811340606 |
| Fax |
|
| Email |
dranitaseth@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Tiwari |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhaman MahavirMedical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9971636443 |
| Fax |
|
| Email |
tiwari.suman2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman Mahavir Medical College and Safdarjung Hoapital |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029, India |
| 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 Suman Tiwari |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesiology and Intensive Care, Ground Floor, Main OT Building, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029, India
South
DELHI |
9971636443
tiwari.suman2002@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 |
Paediatric patients aged 3-10
years of either sex, ASA grade I and II, scheduled for surgery of less than 2 hours duration, with LMA ProSeal insertion under General anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LMA ProSeal insertion by 90 degree rotation technique |
Patient will be given general anaesthesia and LMA ProSeaL will be inserted by
90 degree rotation technique. |
| Comparator Agent |
LMA Proseal insertion by Introducer technique |
Patient will be given general anaesthesia and LMA ProSeal will be inserted with the help of metal introducer. |
| Intervention |
LMA ProSeal insertion by Pharyngoscopic technique |
Patient will be given general anaesthesia and LMA ProSeal will be inserted by Pharyngoscopic technique. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 3 to 10 years of either gender under ASA grade I or II, scheduled for surgery of less than 2 hours duration under general anaesthesia with controlled ventilation using the LMA ProSeal. |
|
| ExclusionCriteria |
| Details |
-Anticipated difficult airway
-Weight <5kg or >kg
-Recent upper respiratory tract infection, sore throat, history of asthma. History of systemic or metabolic disorders. Risk of regurgition or aspiration. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Haemodynamic parameters
Assessment of insertion conditions i.e. insertion time, ease of insertion, number of attempts taken, manipulations done, oropharyngeal seal pressure, ease of orogastric tube placement. |
1 minute before the insertion of device, at the time of insertion and after the time of insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative adverse events i.e. Sore throat or Hoarseness |
After surgery and First postoperative morning |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1.Yun M, Hwang J, Park S, Han S, Park H, Kin J et al. 90 degree rotation technique improves the ease of insertion of the proseal LMA in children. Can J Anaesth. 2011;58:379-383. 2.Elwood T, Cox R. Laryngeal mask insertion with a laryngoscope in paediatric patients. Can J Anaesth.1996;43:435-437 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1-To compare the ease of insertion of LMA ProSeal by three techniques i.e. introducer technique, 90 degree rotation technique and pharyngoscopic technique. 2- Haemodynamic parameters will be recorded before and after insertion of LMA ProSeal. |