| CTRI Number |
CTRI/2021/07/034820 [Registered on: 13/07/2021] Trial Registered Prospectively |
| Last Modified On: |
22/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing airway ultrasound parameters with clinical parameters for prediction of Difficult Airway in adult patients |
|
Scientific Title of Study
|
Upper airway ultrasound versus Wilsons score for prediction of Difficult Airway in adult patients- An Observational Prospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti Petkar |
| Designation |
Associate Professor , Anaesthesiology |
| Affiliation |
Rajarajeshwari Medical College and Hospital, Bangalore, state- Karnataka |
| Address |
Department of Anaesthesiology,
Rajarajeshwari Medical College and Hospital
#202, Kambipura, Mysore Road,
Bengaluru
Department of Anaesthesiology,
Rajarajeshwari Medicalk College and Hospital
#202, Kambipura, Mysore Road,
Bengaluru- 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
07726899533 |
| Fax |
08028437393 |
| Email |
jokiran2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Petkar |
| Designation |
Associate Professor , Anaesthesiology |
| Affiliation |
Rajarajeshwari Medical College and Hospital, Bangalore, state- Karnataka |
| Address |
Department of Anaesthesiology
Rajarajeshwari Medical College and Hospital
#202, Kambipura, Mysore Road,
Bengaluru-560074
State- Karnataka
Bangalore
KARNATAKA
560100
India |
| Phone |
07726899533 |
| Fax |
|
| Email |
jokiran2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Petkar |
| Designation |
Associate Professor , Anaesthesiology |
| Affiliation |
Rajarajeshwari Medical College and Hospital, Bangalore, state- Karnataka |
| Address |
Department of Anaesthesiology
Rajarajeshwari Medical College and Hospital
#202, Kambipura, Mysore Road, Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
07726899533 |
| Fax |
|
| Email |
jokiran2009@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajarajeshwari Medical College and Hospital |
| Address |
#202, Kambipura, Mysore Road, Bengaluru-560074 |
| Type of Sponsor |
Private 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 Jyoti Petkar |
RRMCH Bengaluru |
Department of Anaestheia,RRMCH
#202, Kambipura, Mysore Road, Bengaluru
Bangalore
KARNATAKA |
7726899533
jokiran2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeshwari Medical College and Hospital Bengaluru |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Elective surgery
2.Age group 18 to 65 years
3.ASA grade I -III
4.BMI < 40 kg/m2
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Unable to give consent
3.Pre-existing airway malformations or pathology
like facial or cervical fractures
4.Maxillofacial abnormality
5.Patients with tracheostomy tubes
6.Pregnant patients
7.BMI > 40 kg/ m2
8.Emergency surgery
9.Nasal intubation
10.Intubation with fiberoptic scope or
glidescope
11.Awake intubation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the utility of ultrasound guided DSE-TM in distinguishing easy and difficult laryngoscopy as assessed by CL grading. |
Ultrasound guided airway assessment is done in pre-op holding area and difficult airway grading was done in operation theatre after intubation assessed by Cormack Lahane Grading may be 1 or 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare between US-DSE and Wilsons score for prediction of difficult laryngoscopy |
To compare between US-DSE and Wilsons score for prediction of difficult laryngoscopy in 1 day.
Clinical assessment of airway is done on previous day , Ultrasound guided airway assessment is done onday of surgery in pre-op holding area and difficult airway assessed after laryngoscopy using Cormack Lahane grading and comparison done after intubation .So time point will be 1 day |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
20/07/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Previously clinical parameters were used to predict difficult airway. Now we have quick and handy tool like ultrasound, which can be used to predict difficult laryngosvcopy. Certain parameters can be measured by ultrasonography of the airway which will help us to predict difficult airway in adult patients. Wilsons score is a group indice which predicts difficult airway using clinical parameters. We will be comparing Wilsons score and ultrasound parameters for predicting difficult airway in adult patients. |