| CTRI Number |
CTRI/2020/08/027330 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
16/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study post intubation sore throat and associated risk factors in patients undergoing spine surgeries. |
|
Scientific Title of Study
|
Post intubation sore throat and associated risk factors in patients undergoing spine surgeries;an observational study at SMS Medical College, Jaipur during (2019 –2021 ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kashmira sharma |
| Designation |
Junior resident |
| Affiliation |
SMS MEDICAL COLLEGE JAIPUR |
| Address |
department of anaesthesiology room no 21 second floor dhanvantari opd SMS hospital jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9785483171 |
| Fax |
|
| Email |
kashmirasharma90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
mamta sharma |
| Designation |
Associate professor |
| Affiliation |
sms medical college jaipur |
| Address |
Department of neuroanaesthesia room no 01 first floor bangar divison of SMS hospital jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
mamta sharma |
| Designation |
Associate professor |
| Affiliation |
sms medical college jaipur |
| Address |
Department of neuroanaesthia room no 01 first floor bangar divison of SMS hospital jaipur
Jaipur
RAJASTHAN
3020o4
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
|
Source of Monetary or Material Support
|
| SMS medical college and attached hospital Jaipur |
|
|
Primary Sponsor
|
| Name |
KASHMIRA SHARMA |
| Address |
ROOM NO 401 PG & FAMILY GIRLS HOSTEL NEAR JK LOAN SMS MEDICAL COLLEGE JAIPUR RAJSTHAN 302004 |
| Type of Sponsor |
Other [SELF SPONSERED] |
|
|
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 |
| kashmira sharma |
SMS medical college and attached hospital |
JLN marg adarsh nagar gangawal park jaipur 302004
Jaipur
RAJASTHAN |
9785483171
kashmirasharma90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sms medical college and attached hospital jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M483||Traumatic spondylopathy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group– 18 to 75 yrs.
2 ASA grade I, II
3 Patients willing to give consent for surgery
|
|
| ExclusionCriteria |
| Details |
1 Emergency surgery
2 Patient with anticipated difficult intubation
3 Loose teeth
4 Current upper respiratory tract infections, pre-existing sore throat hoarseness
5 Patients requiring nasogastric tube insertion
6 Patient with psychiatric disorders hindering proper evaluation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Percentage of cases
who develop sore
throat.
|
1,6,24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prediction of post intubation sore throat on the basis of age, sex, body mass index (BMI) of patient, ASA physical status, smoking ,endotracheal cuff pressure, coughing during emergence ,duration of surgery, patient position during surgery and intubation factors including; technique, attempt and size of endotracheal tube, cormac-lehane grade, need for external pressure during intubation. |
1,6,24 hrs |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
27/08/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this is observatioal study to estimate the risk of postoperative sore throat within 24 hrs and various associated risk factors such as age,sex,body mass index ASA status,smoking,endotracheal cuff pressure,coughing during emergence,duration of surgery,patient position during surgery and intubation technique ,attempt,size of ET tube,cormac-lehane grade,need for external pressure during intubation,that will be conducted over 400 pts during 6 month period in sms medical college in india. the primary outcome measures will be all cause sore throat with grading at 1,6,24 hrs . |