| CTRI Number |
CTRI/2020/05/025094 [Registered on: 11/05/2020] Trial Registered Prospectively |
| Last Modified On: |
09/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find out which supra glottic airway devices (i-gel or Ambu AuraGain) provides better sealing pressure, better ease of gastric tube insertion,number of successful insertion attempts,less peri operative complications in paediatric patients undergoing elective surgery |
|
Scientific Title of Study
|
Comparison of clinical performance of i-gel and Ambu AuraGain in paedidatric patients - A randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarayu V |
| Designation |
MD student |
| Affiliation |
Armed Forces Medical College,Pune |
| Address |
Department of Anaesthesiology and Critical Care, Armed Forces Medical College,Wanowrie,Pune,Maharastra,Pincode -411040
Department of Anaesthesiology and Critical Care, Armed Forces Medical College,Wanowrie,Pune,Maharastra,Pincode -411040
Pune
MAHARASHTRA
411040
India |
| Phone |
8778800503 |
| Fax |
|
| Email |
sarauvenkatesan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navdeep Sethi |
| Designation |
Professor and Guide |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Professor, Department of Anaesthesiology and Critical Care,Armed Forces Medical College,Wanowrie,Pune,Maharastra,Pincode-411040
Professor, Department of Anaesthesiology and Critical Care,Armed Forces Medical College,Wanowrie,Pune,Maharastra,Pincode-411040
Pune
MAHARASHTRA
411040
India |
| Phone |
8195915566 |
| Fax |
|
| Email |
drnsethi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sarayu V |
| Designation |
MD student |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Anaesthesiology and Critical Care,Armed Forces Medical College,Wanowrie,Pune,Maharastra,Pincode-411040
Department of Anaesthesiology and Critical Care,Armed Forces Medical College,Wanowrie,Pune,Maharastra,Pincode-411040
Pune
MAHARASHTRA
411040
India |
| Phone |
8778800503 |
| Fax |
|
| Email |
sarauvenkatesan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College,Wanowrie,Pune -411040 |
|
|
Primary Sponsor
|
| Name |
Sarayu V |
| Address |
Junior Resident,Department of Anaesthesiology and Critical Care,Armed Forces Medical College,Wanowrie,Pune-411040 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Navdeep Sethi |
Professor,Department of Anaesthesiology and Critical Care,Armed Forces Medical College,Wanowrie,Pune -411040 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sarayu V |
Armed Forces Medical College |
Department of Anaesthesiology and Critical Care, Armed Forces Medical College,Wanowrie,Pune,Maharastra,Pincode -411040
Pune
MAHARASHTRA |
8778800503
sarauvenkatesan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All children(boys and girls)aged between 6 months and 6 years old with ASA 1-3 and weight between 5 and 20 kg undergoing elective surgery at a tertiary care hospital |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of clinical performance of Ambu AuraGain in paediatric patients |
Patients will be randomly allocated into one groups,namely Ambu AuraGain.Following parameters will be observed: Oropharyngeal sealing pressure,insertion time,success rate at first attempt,ease of gastric tube insertion,peri-operative adverse effetcs |
| Comparator Agent |
Comparison of clinical performance of i-gel in paediatric patients |
Patients will be randomly allocated into one groups,namely i-gel.Following parameters will be observed: Oropharyngeal sealing pressure,insertion time,success rate at first attempt,ease of gastric tube insertion,peri-operative adverse effetcs |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
All children(both boys and girls)aged between 6 months and 6 years old with ASA 1-3 and weight between 5 and 20 kgs. |
|
| ExclusionCriteria |
| Details |
Known difficult airway,high risk of aspiration including those with gastro-intestinal stenosis or stricture, symptoms or signs of upper respiratory tract infection,patients who deny consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in outcome between oropharyngeal sealing pressure at 1 in after successful insertion and 10 min after insertion of the device |
All patients for 18 months period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The difference in outcome in terms of insertion time and success rate at first attempt,the degree of ease of gastric tube insertion,peri-operative adverse effects. |
All patients for 18 months period |
|
|
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)
|
10/06/2020 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The trial is a randomized,single blinded, to determine the oropharyngeal sealing presssure and the changes in oropharyneal sealing pressure during 10 mins.The secondary outcome includes, the insertion time and success rate at first attempt,the degree of ease of gastric tube insertion and peri-operative adverse effects. All children ,scheduled at a tertiary care hospital for elective paediatric surgery under general anaesthesia not requiring tracheal intubation will be the potential study population.The duration of the study will be for 18 months. |