| CTRI Number |
CTRI/2024/02/063143 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utility Of Airway Ultrasound For Prediction Of Difficult Laryngoscopic View In Patients Posted For Elective Surgeries Under General Anaesthesia |
|
Scientific Title of Study
|
Utility of airway ultrasound for prediction of difficult laryngoscopic view in patients posted for elective surgeries under general anaesthesia |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharti Maravi |
| Designation |
Post graduate student |
| Affiliation |
VIMSAR, Burla |
| Address |
Department Of Anaesthesiology ,VIMSAR Burla, Sambalpur, Orissa, 768017,India
Sambalpur
ORISSA
768017
India |
| Phone |
9685458738 |
| Fax |
|
| Email |
bhartimaravi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharti Maravi |
| Designation |
Post graduate student |
| Affiliation |
VIMSAR Burla |
| Address |
Department Of Anaesthesiology ,VIMSAR Burla, Sambalpur, Orissa,768017,India
Sambalpur
ORISSA
768017
India |
| Phone |
9685458738 |
| Fax |
|
| Email |
bhartimaravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharti Maravi |
| Designation |
Post graduate student |
| Affiliation |
Vimsar Burla |
| Address |
Department Of Anaesthesiology, VIMSAR Burla, Sambalpur, Orissa, 768017,India
Sambalpur
ORISSA
768017
India |
| Phone |
9685458738 |
| Fax |
|
| Email |
bhartimaravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| VIMSAR Burla, Dist.Sambalpur
State-Odisha,PIN 768017 |
|
|
Primary Sponsor
|
| Name |
Bharti Maravi |
| Address |
VIMSAR Burla, Sambalpur Odisha
PIN 768017,India |
| 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 |
| DrMahendra Ekka |
Surgery OT,VIMSAR Burla |
VIMSAR Burla, Sambalpur, Orissa
Sambalpur
ORISSA |
9861115524
mekka15071976@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIREC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K810||Acute cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMI less than 30 kg per meter 2
ASA physical status one and two |
|
| ExclusionCriteria |
| Details |
Patient refusal
Pregnant woman
Maxillofacial injury, Cervical spine injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Predict difficult laryngoscopic view in terms of distance from skin to epiglottis and distance from skin to vocal cord |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| For Prediction of difficult laryngoscopic view distance from skin to epiglottis is better than distance from skin to vocal cord |
20 minutes |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
10/03/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
18 -65 yr age either sex ,undergoing elective surgeries under general anaesthesia was preoperative assess modified mallampati score, TMD,SMD Neck circumference and airway ultrasound was done preoperative after that on day of surgeries airway ultrasound was done to predict difficult laryngoscopic view and correlate with cormack-lehane grade |