| CTRI Number |
CTRI/2023/11/060147 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
15/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
correlation study |
| Study Design |
Other |
|
Public Title of Study
|
A forward study to compare clinical parameters and ultrasonogram for throat examination |
|
Scientific Title of Study
|
A prospective correlation study between airway ultrasound and clinical parameters for the prediction of difficult laryngoscopy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramya R |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Center |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Center
Ariyur, Puducherry.
Sri Venkateshwaraa Medical College Hospital and Research Center
Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6382595078 |
| Fax |
|
| Email |
ramyaraju16.rr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arthi |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Center
Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
7895683205 |
| Fax |
|
| Email |
dr.arthimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramya R |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Center |
| Address |
D block premium hostel room no.15
Sri Venkateshwaraa Medical College Hospital and Research Center
Ariyur, Puducherry.
D block premium hostel room no.15
Sri Venkateshwaraa Medical College Hospital and Research Center
Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
6382595078 |
| Fax |
|
| Email |
ramyaraju16.rr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Sri Venkateshwaraa Medical college Hospital and Research Centre Ariyur Pondicherry 605102 |
|
|
Primary Sponsor
|
| Name |
Ramya R |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Cenre
Ariyur Pufucherry 605102 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ramya R |
Sri Venkateshwaraa Medical College Hospital and Research Cenre Ariyur, Puducherry-605 102 |
Department of Anaesthesiology
Room no .8, OT complex, Ariyur
Puducherry
Pondicherry
PONDICHERRY |
6382595078
ramyaraju16.rr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex with age limit 18 to 60 years
2.Patients belonging to American Society of Anaesthesiologist grade 1 and 2
3.Patients who give a valid informed consent |
|
| ExclusionCriteria |
| Details |
1.Maxillofacial anomalies
2.Restricted neck movents
3.Body mass index more than 35kg/m2
4.Limited mouth opening
5.Obstetric patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO determine the role of skin to hyoid,skin to thyrohyoid membrane & tongue thickness using ultrasound & routine clinical parameters for patients under going elective surgical procedure under general anaesthesia |
40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO determine difficult laryngoscopy by Cormack Lehane grading |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
28/11/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective correlation study between airway ultrasound and clinical parameters for the prediction of difficult laryngoscopy |