| CTRI Number |
CTRI/2024/10/075717 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparasion study of an App for Difficult Airway Prediction using Clinical and Ultrasound Parameters Versus Conventional Methods for Prediction of difficult Airway.
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Scientific Title of Study
|
Comparative study of Prediction of difficult airway by an Application using Clinical and Ultrasound Parameters Versus Conventional Methods - A Randomized control trail |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKaberi behera |
| Designation |
Post graduate (junior resident) |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital.Room No 2(two), 2nd floor(division) , Department of Anaesthesia ,
Chennai
TAMIL NADU
602105
India |
| Phone |
7358213566 |
| Fax |
|
| Email |
Kaberibehera127@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKaberi behera |
| Designation |
Post graduate (junior resident) |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital,Room No 2(two) ,2nd floor(division), department of Anaesthesia
Chennai
TAMIL NADU
602105
India |
| Phone |
7358213566 |
| Fax |
|
| Email |
Kaberibehera127@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGunasekaran |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesia, Saveetha medical college and hospital
Chennai
TAMIL NADU
602105
India |
| Phone |
9566137571 |
| Fax |
|
| Email |
guna.kali@yahoo.com |
|
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Source of Monetary or Material Support
|
| saveetha medical college and hospital,Tamil Nadu, chennai - 602105,India |
|
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Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesiology,Saveetha medical college and hospital,tamilnadu, chennai - 602105,India |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gunasekaran |
Saveetha medical college and hospital |
2nd floor ,Room No 1 ,Department of Anaesthesia
Chennai
TAMIL NADU |
7358213566
Kaberibehera127@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional ethics committee |
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, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Difficult airway Prediction and management option using Conventional Methods |
Duration of intervention- 1 year (365 days ) |
| Intervention |
Difficult airway Prediction and management option using Difficult Airway application |
Intervention duration - 1 year (365 days ) |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA PHYSICAL STATUS 1 and 2,patient undergoing elective General anesthesia |
|
| ExclusionCriteria |
| Details |
Uncooperative patients |
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
To Predict Difficult Airway In Adults Using Clinical And Ultrasound Parameter
|
We will assess the time taken for intubation, 3mins - Difficult intubation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the predictive ability of Airway application based airway assessment as predictors of difficult laryngoscopy & intubation using Cormack-lehane (CL), & intubation difficulty scale (IDS). |
No of attempts taken (more 3 time - difficult intubation) .
Requirements of specialized equipments or techniques
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Target Sample Size
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Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
22/11/2024 |
| 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="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Preoperative Airway assessment- Assessment will be done by using airway application (clinical and ultrasound parameter) or Conventional Methods (clinical parameter) which will provide prediction of difficult airway and management option for the same . The difficult airway is a complex interaction of patient anatomy, clinical circumstances, and clinician skills of physicians managing the airway. A difficult airway remains a significant factor contributing to mortality and morbitiy in anesthetized patients. Its consequences range from transient hemodynamic changes to hypoxic brain injury and cardiac arrest. .Airway assessment is recommended to anticipate and prepare for a difficult airway before starting airway management. Ultrasonography is a useful adjunct to conventional clinical airway assessment tools, as it can be used for visualizing the relevant anatomy and critical structure of the airway. It is a Novel, noninvasive tool. Our primary objective of this study is to Compare the predictive ability of difficult laryngoscopy and intubation by an Airway Application with conventional assessment method. The secondary objective is to determine the predictive ability of Airway application based airway assessment as predictors of difficult laryngoscopy and intubation using Cormack-lehane (CL), and intubation difficulty scale (IDS).
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