| CTRI Number |
CTRI/2024/06/069295 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound Airway Assesment vs El Ganzouri index |
|
Scientific Title of Study
|
Preoperative Airway assessment using EL Ganzouri Index vs Ultrasound |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandini Bhandari |
| Designation |
DNB(3 year course) post graduate Redsident |
| Affiliation |
NH MMI Superspecialty Hospital RAIPUR |
| Address |
OT complex , Department of Anaesthesiology ,2nd floor, MMI Narayana superspecialty Hospital , Dhamtari Road, Lalpur, Raipur
Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
09713773401 |
| Fax |
|
| Email |
nandu20bhandari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Andappan |
| Designation |
Senior Consultant |
| Affiliation |
NH MMI RAIPUR Superspecialty Hospital |
| Address |
OT complex , Department of Anaesthesiology , 2nd floor , MMI Narayana superspecialty Hospital , Dhamtari Road, Lalpur, Raipur,
Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9584411011 |
| Fax |
|
| Email |
arunandappan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Andappan |
| Designation |
Senior Consultant |
| Affiliation |
NH MMI RAIPUR Superspecialty Hospital |
| Address |
OT complex, Department of Anesthesiology, 2nd floor, NH MMI Superspecialty Hospital, Dhamtari Road, Lalpur, Raipur ,Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
9584411011 |
| Fax |
|
| Email |
arunandappan@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMI Narayana Superspecialty Hospital, Near Dhamtari Road , Lalpur, Raipur ,Chhattisgarh, pincode- 492001, India |
|
|
Primary Sponsor
|
| Name |
MMI Narayana superspecialty Hospital |
| Address |
new Dhamtari road, Pachpedi naka ,Lalpur, Raipur, Chhattisgarh , India , PIN - 492001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrNandini Bhandari |
NH MMI Superspecialty Hospital |
Department of anesthesia,OTC 2nd floor near Pachpedi Naka ,Lalpur Raipur
Raipur
CHHATTISGARH |
09713773401
nandu20bhandari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe,AIIMS,Raipur(CG) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z409||Encounter for prophylactic surgery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL due to Observational trail |
| Comparator Agent |
NIL |
NIL due to Observational Trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I or II |
|
| ExclusionCriteria |
| Details |
Patients with obvious abnormalities of the airway who should be scheduled for
awake intubation (e.g. facial fractures, tumors, etc.).
Cervical spine fractures
Tracheostomy tube.
Unable to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-To compare preoperative assessment using El Ganzouri vs Ultrasonographic
assessment of the airway and subsequent view of laryngoscopy at endotracheal
intubation |
outcome will be assessed within 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare parameters of Ultrasonographic assessment in prediction of difficult
intubation at laryngoscopy |
within12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Thesis topic- Preoperative airway assessment using El Ganzouri index versus Ultrasonography
Airway Management is a critical skill in the practice of several medical specialities including anaesthesia, emergency medicine, and intensive care settings. Various clinical criteria are used to evaluate patient’s airway. Ultrasonography (USG) of the upper airway is capable of providing detailed anatomic information .The use of point of care ultrasonography for the prediction of difficult laryngoscopy and intubation has shown some promises in small studies but its overall value has yet to be established. El ganzouri index scoring system involves various criteria like Modified Mallampati classification,mouth opening,ability to prognath,neck extension,history of difficult intubation,body weight,thyromental distance. |