| CTRI Number |
CTRI/2024/10/075624 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of ultrasonography to predict difficult airway by using airway parameters measurement |
|
Scientific Title of Study
|
Ultrasonographic measurement of three domain of airway to predict 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 |
DR SUSHMA H |
| Designation |
SENIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE,MANIPAL |
| Address |
OR Office,Department of Anesthesiology ,1st floor, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9483305224 |
| Fax |
|
| Email |
sushmahaithal237@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUSHMA H |
| Designation |
SENIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE,MANIPAL |
| Address |
OR Office,Department of Anesthesiology ,1st floor, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9483305224 |
| Fax |
|
| Email |
sushmahaithal237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUSHMA H |
| Designation |
SENIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE,MANIPAL |
| Address |
OR Office, Department of Anesthesiology ,1st floor, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9483305224 |
| Fax |
|
| Email |
sushmahaithal237@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE MANIPAL,UDUPI DISTRICT,KARNATAKA STATE,INDIA 576104 |
|
|
Primary Sponsor
|
| Name |
DR SUSHMA H |
| Address |
C-1304,ROYAL EMBASSY,VIDYARATNA NAGAR,MANIPAL,UDUPI DISTRICT,KARNATAKA STATE,INDIA 576104 |
| 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 Sushma H |
KASTURBA MEDICAL COLLEGE,MANIPAL |
OR Office,Department of Anesthesiology ,1st floor, Kasturba Hospital, Manipal,Udupi district,Karnataka state,India 576104
Udupi
KARNATAKA |
9483305224
sushmahaithal237@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 |
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 |
a.Patients scheduled for elective procedures under General anaesthesia.
b.Age 18-70years
c.American Society of Anaesthesiologists -physical status( ASA-PS) class 1 and 2 patients
|
|
| ExclusionCriteria |
| Details |
a. Patients with facial trauma
b. Patients with facial tumors
c. Patients with cervical trauma
d. Patients with upper airway anatomical abnormality
e. Patients with history of difficult airway in previous surgery
f. Patients who are pregnant
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonographic measurement of paramteres of airway will be helpful in identifying difficult airway |
in the preoperative period before shifting inside theatre |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The efficacy of ultrasonography in predicting difficult airway can be compared with clinical parameters to predict difficult airway. |
In the preoperative period |
|
|
Target Sample Size
|
Total Sample Size="149"
Sample Size from India="149"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="149" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
14/02/2025 |
| 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)
|
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
|
Aim of the study is to predict difficult laryngoscopy with ultrasonography using the measurement of three domains in airway-Oral space domain (tongue thickness),Anterior neck soft tissue thickness domain (ANS-VC) and anatomic position domain (HMDR)Inspite of multiple clinical parameters for assessment of difficult airway,incidence of unanticipated difficult laryngoscopy is (1-8%).Clinical assessment can not be done in uncooperative and unconscious patients.Hence USG airway is helpful in overcoming the above said troubles.Hence this study will be helpful in identifying difficult airway.After obtaining clearance from the institutional ethics committee and registering in CTRI,informed consent will be taken from the patient on the day before the surgery.Patient selection will be based on the inclusion and exclusion criteria posted for elective surgery under general anaesthesia.In the preanaesthetic evaluation,airway assessment like Modified Mallampatti Classification,Thyromental distance,Sternomental distance and interincisor gap distance and neck circumference will be measured using a scale in cms. On the day of the surgery,enrolled patients will undergo USG examination of airway using sonosite in the preoperative room by a skilled investigator.ANS-VC measurement is done by keeping a linear probe (10-13MHz frequency) in transverse plane,with the patient lying in supine position and head kept in neutral position.ANS-VC will be measured from skin to anterior commissure of true VC by keeping the probe at the level of vocal cords,depth measurement is done in the central axis of neck in cm.HMDR mearurement is done using a curvilinear probe(4-10MHz frequency).Probe is kept in sagittal plane in suprahyoid region and HMD is calculated by measuring distance from hyoid bone and mentum in neutral position and extended position.HMDR is calculated by dividing HMD in neutral to HMD in extended position.Tongue thickness is measured by stretching the neck and placing probe under the chin in median sagittal plane using a curvilinear probe.Maximal vertical dimension from tongue to submental skin is measured.After induction of patient using standard method,grades of laryngoscopy is noted and compared that with the ultrasonographic parameters |