| CTRI Number |
CTRI/2024/02/063217 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of ultrasound in assessment of difficult airway |
|
Scientific Title of Study
|
Role of ultrasound in identifying patients at risk for difficult mask ventilation and intubation based on tongue thickness: a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seetepalli Venkata Naga Sai Krishna |
| Designation |
junior resident |
| Affiliation |
Kasturba medical college- Manipal |
| Address |
Department of Anesthesiology, Kasturba medical college and Hospital, Manipal-576104, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
09701457950 |
| Fax |
|
| Email |
seethepalli.sai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rama Rani K |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college- Manipal |
| Address |
Department of Anesthesiology, Kasturba medical college and Hospital, Manipal-576104, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9902938044 |
| Fax |
|
| Email |
rama.rani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rama Rani K |
| Designation |
Associate professor |
| Affiliation |
Kasturba medical college- Manipal |
| Address |
Department of Anesthesiology, Kasturba medical college and Hospital, Manipal-576104, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9902938044 |
| Fax |
|
| Email |
rama.rani@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba hospital and medical college, Manipal-576104, Karnataka. |
|
|
Primary Sponsor
|
| Name |
seetepalli venkata naga sai krishna |
| Address |
Department of Anesthesiology, Kasturba medical college and Hospital, Manipal-576104, Karnataka. |
| 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 Seetepalli venkata naga sai krishna |
KASTURBA HOSPITAL AND MEDICAL COLLEGE |
Department of Anesthesiology, Kasturba medical college and Hospital, Manipal-576104, Karnataka.
Udupi
KARNATAKA |
09701457950
seethepalli.sai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional ethics committee-2 (student research) |
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 |
70.00 Year(s) |
| Gender |
Both |
| Details |
all patients undergoing elective surgery under general anesthesia with asa physical score 3 or less with BMI less than 30 are included |
|
| ExclusionCriteria |
| Details |
patients with identified difficult airway and with risk of aspiration are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| use of ultrasound measured tongue thickness as predictor of difficult mask ventilation |
Tongue Thickness is measured using ultrasound preoperatively and compared with difficulty in mask ventilation immediately after induction with general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of ultrasound measured tongue thickness with difficult intubation |
Tongue thickness is measured preoperatively using ultrasound & compared with intubation difficulty immediately after induction with general anaesthesia & after mask ventilation |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
Final Enrollment numbers achieved (Total)= "125"
Final Enrollment numbers achieved (India)="125" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
04/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 significant challenge for an
anaesthesiologist and inability to establish a secured airway can lead to morbidity and
mortality. There are many clinical parameters described to identify difficult mask ventilation
and intubation which includes obesity, elderly patients, abnormality of teeth, presence of
beard, Mallampati score, thyromental distance, mouth opening. However, the ability of these
parameters to accurately predict difficult airway is still poor. In recent times, seeking a more
accurate method for predicting difficult airway management has become necessary, and
ultrasound has emerged as a promising option due to its non-invasive nature, costeffectiveness, and ease of handling. The role of ultrasound measured tongue thickness in
predicting difficult mask ventilation and intubation has been studied infrequently. |