| CTRI Number |
CTRI/2024/03/063699 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usage of ultrasonographic airway parameters in predicting difficult mask ventilation in patients undergoing general anesthesia |
|
Scientific Title of Study
|
UTILITY OF ULTRASONOGRAPHIC AIRWAY PARAMETERS IN PREDICTING
DIFFICULT MASK VENTILATION
A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ganeshamoorthy B |
| Designation |
postgraduate |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology
sri ramachandra institute of higher education and research,
Ramachandra Nagar, Porur, Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9092129443 |
| Fax |
|
| Email |
drganeshamoorthybaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soma Ganesh Raja |
| Designation |
Associate Professor |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology
sri ramachandra institute of higher education and research,
Ramachandra Nagar, Porur, Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9894162665 |
| Fax |
|
| Email |
drsoms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soma Ganesh Raja |
| Designation |
Associate Professor |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology
sri ramachandra institute of higher education and research,
Ramachandra Nagar, Porur, Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9894162665 |
| Fax |
|
| Email |
drsoms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Dr Ganeshamoorthy B |
| Address |
A6, Department of Anaesthesiology and Pain Medicine
Sri Ramachandra institute of higher education and research, Porur , Chennai 600116 |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 Ganeshamoorthy B |
Sri Ramachandra institute of higher education and research |
Room no A6, 6th floor , Department of Anaesthesiology and Pain Medicine
Sri Ramachandra institute of higher education and research, Porur, Chennai 600116
Chennai
TAMIL NADU |
9092129443
drganeshamoorthybaskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra institute of higher education and research, Porur, Chennai 600116 |
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
|
| Type |
Name |
Details |
| Intervention |
nill |
nill |
| Comparator Agent |
nill |
nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Requiring elective surgery under general Anesthesia Requiring mask ventilation |
|
| ExclusionCriteria |
| Details |
Expected difficult Laryngoscopy
Indication to Awake Fiberoptic intubation
Facial abnormality
Previous wound or oro maxillofacial Surgeries
Parturient
Need for Rapid Sequence induction
Patient Refusal
Inability to give consent for study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the predictive validity of upper airway ultrasound measurements (DLA,
LPT, TT) in predicting difficult mask ventilation among adults during general anaesthesia |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the differences in predictive validity between the pre & post induction
ultrasonographic measurements (DLA, LPT, TT) in predicting difficult mask ventilation
among adults during general anaesthesia |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
Final Enrollment numbers achieved (Total)= "264"
Final Enrollment numbers achieved (India)="264" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
07/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Unanticipated difficult airway is a potentially life-threatening event during elective or emergency surgery. Airway assessment using point of care ultrasound has recently been proposed as a useful, simple, and non-invasive bedside method as an adjunct to clinical evaluation which can detect morphologic changes in upper airway. Our study aims to evaluate the changes of upper airway after anaesthesia induction and using pre-anaesthetic ultrasound measurements of distance between lingual arteries (DLA), Tongue thickness (TT), Lateral pharyngeal wall thickness (LPT) in predicting difficult mask ventilation. |