| CTRI Number |
CTRI/2023/01/048922 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
07/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasonography of the anterior neck to predict difficult airway by measuring depth at various levels. |
|
Scientific Title of Study
|
Measurement of anterior neck thickness by ultrasonography at various levels for prediction of difficult laryngoscopy.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sapna Tekkatte Sudeendra Kumar |
| Designation |
Senior resident |
| Affiliation |
Sanjay Gandhi Institute of Trauma and Orthopedics |
| Address |
Sanjay Gandhi Institute of Trauma and Orthopedics, Byrasandra, behind Nimhans Hospital, 1st block, Jaya nagar east, Bengaluru
Byrasandra Bangalore
Bangalore
KARNATAKA
560011
India |
| Phone |
9481529918 |
| Fax |
|
| Email |
dr.sapnats@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lokesh Kumar K S |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Institute of Trauma and Orthopedics |
| Address |
Sanjay Gandhi Institute of Trauma and Orthopedics, Byrasandra, behind Nimhans Hospital, 1st block, Jaya nagar east, Bengaluru
Byrasandra Bangalore
Bangalore
KARNATAKA
560011
India |
| Phone |
9481529918 |
| Fax |
|
| Email |
dr.lokesh123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Tekkatte Sudeendra Kumar |
| Designation |
Senior resident |
| Affiliation |
Sanjay Gandhi Institute of Trauma and Orthopedics |
| Address |
Sanjay Gandhi Institute of Trauma and Orthopedics, Byrasandra, behind Nimhans Hospital, 1st block, Jaya nagar east, Bengaluru
Byrasandra Bangalore
Bangalore
KARNATAKA
560011
India |
| Phone |
9481529918 |
| Fax |
|
| Email |
dr.sapnats@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Institute of Trauma and orthopedics, Bangalore |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi institute of trauma and orthopedics |
| Address |
Byrasandra, behind Nimhans hospital, bangalore |
| Type of Sponsor |
Government medical college |
|
|
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 Sapna Tekkatte Sudeendra Kumar |
Sanjay Gandhi Institute of Trauma and orthopedics |
Major O T complex, Sanjay Gandhi Institute of Trauma and Orthopedics, Byrasandra, behind Nimhans Hospital, 1st block, Jaya nagar east, Bengaluru
560011
Bangalore
KARNATAKA |
9481529918
dr.sapnats@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjay Gandhi institute of trauma and orthopedics ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists I ,II or III
Scheduled for elective surgery and requiring general anesthesia with direct laryngoscopy.
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Edentuolus patients
Patients in whom the interincisor gap was less than 3 cm
Patients with head and neck pathologies
Parturients
Rapid sequence intubation
Pre-existing limitation or pain with cervical spine movement.
Radiotherapy at the cervical level.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prediction of difficult airway by Cormack Lehane scale |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts at intubation, Need for alternative Difficult intubation approaches, Inability to secure the airway |
6 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/01/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Unpredictable difficult laryngoscopy remains a challenge for anesthesiologists. Assessment of airway preoperatively is an essential part of predicting difficulty in airway management. The established clinical predictors of difficult airway have limitations in routine practice.
Ultrasound evaluation of the airway is a modality which is increasingly being used as a powerful adjunct in airway assessment and management. Yet, there are no well-defined sonographic criteria that can predict the possibility of encountering a difficult airway.
This study will assess feasibility to predict difficult airway based on anterior neck thickness at various levels.
|