CTRI Number |
CTRI/2013/02/003364 [Registered on: 08/02/2013] Trial Registered Retrospectively |
Last Modified On: |
04/02/2013 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A Comparative study of two different type of airway tubes in infants, for short surgeries |
Scientific Title of Study
|
A Comparative study of LMA size-1 vs i-gel size-1 in infants undergoing daycare procedures |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
EC/04/11/243 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Deepanjali Pant |
Designation |
Senior Consultant |
Affiliation |
Sir Ganga Ram Hospital New Delhi |
Address |
Dept of Anaesthesiolog Pain & Perioperative Medicine
Sir Ganga Ram Hospita New Delhi
Central DELHI 110060 India |
Phone |
01142252513 |
Fax |
|
Email |
deepanjalipant@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Deepanjali Pant |
Designation |
Senior Consultant |
Affiliation |
Sir Ganga Ram Hospital New Delhi |
Address |
Dept of Anaesthesiolog Pain & Perioperative Medicine
Sir Ganga Ram Hospita New Delhi
Central DELHI 110060 India |
Phone |
01142252513 |
Fax |
|
Email |
deepanjalipant@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Archna Koul |
Designation |
Associate Consultant |
Affiliation |
Sir Ganga Ram Hospital New Delhi |
Address |
Dept of Anaesthesiology Pain & Perioperative Medicine
Sir Ganga Ram Hospital New Delhi
Central DELHI 110060 India |
Phone |
01142252513 |
Fax |
|
Email |
archnakoul1@gmail.com |
|
Source of Monetary or Material Support
|
Dept of Anaesthesiology Pain Perioperative Medicine
Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi |
|
Primary Sponsor
|
Name |
Dept of Anaesthesiology Pain Perioperative Medicine |
Address |
Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi - 110060 |
Type of Sponsor |
Research institution and hospital |
|
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 Archna Koul |
Sir Ganga Ram hospital |
Department of Anaesthesiology, Pain & Perioperative Medicine
Sir Ganga Ram Hospital, New Delhi
Central DELHI |
01142252513
archnakoul1@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sir Ganga Ram Hospital Ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Lower abdominal surgery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
i-gel size 1 |
comparison of i-gel size 1 with laryngeal mask airway size 1 in paedriatric patients undergoing daycare procedures |
Comparator Agent |
Laryngeal Mask Airway size 1 |
comparison of i-gel size1 with laryngeal mask airway size 1 in paedriatric patients undergoing day care surgeries |
|
Inclusion Criteria
|
Age From |
1.00 Day(s) |
Age To |
1.00 Year(s) |
Gender |
Both |
Details |
1. ASA grade I/II
2. Weight 2Kg to 5 Kg |
|
ExclusionCriteria |
Details |
1. ASA physical status greater than II
2. Risk of pulmonary aspiration
3. Potential difficult airway
4. Children who require surgery in positions other than supine or lithotomy
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Seal pressure achieved |
From induction af anaesthesia to awakening from anaesthesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Ease of insertion
2. Stability of the device
|
From induction af anaesthesia to awakening from anaesthesia |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/09/2011 |
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="15" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The laryngeal mask airway and similar supraglottic devices use an inflatable cuff to wedge into the upper oesophagus and provide a perilaryngeal seal. Inflatable masks provide an airway seal but can have negative impact on how these devices are inserted, how they are positioned and how they can perform. Inflation using the recommended volumes increases mask rigidity and decreases conformity with perilaryngeal structures. Mechanically, inflation can cause movement of the device. Inflatable masks also have the potential to cause tissue distortion, venous compression and nerve injury. Depending upon their material they can absorb anaesthetic gases leading to increased mucosal pressures. Size 1 LMA which is used in children upto 5 kg is vulnerable to displacement with slight movement of head of the child or anaesthesia circuit or with cuff inflation.
Currently the classical supralaryngeal airway devices (SAD) have been modified and i-gelTM airway is one of the alternative SADs which has been recently introduced. The i-gel airway (Intrasurgical Ltd, Wokingham, Berkshire, UK) is a novel, single patient use, disposable supraglottic device made up of a thermoplastic elastomer (SEBS, styrene ethylene butadiene styrene) with a soft durometer (hardness) and gel like feel. It is designed to achieve a mirrored impression of the pharyngeal and laryngeal structures and to provide perilaryngeal seal without cuff inflation. A supraglottic airway without a cuff has potential advantages including easier insertion and use, minimal risk of tissue compression, stability after insertion (i.e. no position change with cuff inflation) |