| CTRI Number |
CTRI/2020/04/024694 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
12/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
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Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
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Public Title of Study
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Use of ultrasound to measure the volume of tonsils in children undergoing tonsillectomy surgery and correlate the ultrasound findings with STUBR ( snoring, trouble-breathing, Un-refreshed)score and actual tonsil size to predict postoperative respiratory complications |
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Scientific Title of Study
|
Ultrasonographic Assessment of Tonsillar Volume in Children undergoing tonsillectomy: A predictor of post-operative morbidity
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puneet Khanna |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
5th floor, Department of Anaesthesia, Teaching Block,
AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
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Details of Contact Person
Scientific Query
|
| Name |
Puneet Khanna |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
5th floor, Department of Anaesthesia, Teaching Block,
AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Khanna |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
5th floor, Department of Anaesthesia, Teaching Block,
AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
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Source of Monetary or Material Support
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Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI-110029 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| puneet khanna |
AIIMS, New Delhi |
Department of Anaesthesia and Department Of ENT, AIIMS
New Delhi
South West
DELHI |
9873106516
k.punit@yahoo.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
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Intervention / Comparator Agent
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Inclusion Criteria
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| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
pediatric recurrent tonsillitis patients with or without OSA (obstructive sleep apnoea) undergoing tonsillectomy alone
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| ExclusionCriteria |
| Details |
1) Subjects aged more than 14
2) Subjects undergoing adenoidectomy along with tonsillectomy
3) Subjects not willing for surgery
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| Ultrasound assisted tonsillar measurement and its correlation with STUBR (Snoring, trouble breathing, un-Refreshed) Score to predict post-operative respiratory complications in pediatric patients undergoing tonsillectomy |
up to 12 hours after surgery |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| To assess role of ultrasound in reducing postoperative respiratory complications in pediatric patients undergoing tonsillectomy |
up to 12 hours after surgery |
| To study and compare ultrasound assisted tonsillar measurement with actual tonsillar size in children undergoing tonsillectomy. |
once tonsil specimen is available during surgery |
|
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Target Sample Size
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Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
01/05/2020 |
| 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 |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Tonsillectomy is one of the commonest surgical procedures performed in pediatric population. Indication of tonsillectomy ranges from recurrent tonsillitis to obstructive sleep apnoea. Management of such patients is often challenging for the anaesthetists, especially in children with obstructive sleep apnoea. The children undergoing tonsillectomy are at increased risk of postoperative respiratory complications. Therefore, It becomes imperative to predict anticipated complications in advance to improve post-operartve outcome. Ultrasound, an easily accessible, non-invasive tool, can be used to measure tonsillar volume in children undergoing tonsillectomy. so, we aim to measure tonsillar volume with ultrasound and correlate it with STUBR ( snoring, trouble-breathing, unrefreshed) score to predict post-operative respiratory complications.
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