| CTRI Number |
CTRI/2022/03/041159 [Registered on: 16/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
In adult patients undergoing surgery under General Anaesthesia, we will co-relate the findings of ultrasound guided and conventional methods of airway assessment with the extent of visibility of vocal cords during endotracheal intubation. |
|
Scientific Title of Study
|
A study about correlation between ultrasonography guided method and the conventional methods for assessment of airway and Cormack-Lehane grading in adult patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swapnil Keshav |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences, Patna |
| Address |
Department Of Anaesthesiology And Critical Care Medicine, I.G.I.M.S, Patna
Patna
BIHAR
800014
India |
| Phone |
9576515377 |
| Fax |
|
| Email |
swapnilkeshav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swapnil Keshav |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Department Of Anaesthesiology And Critical Care Medicine, I.G.I.M.S, Patna
Patna
BIHAR
800014
India |
| Phone |
9576515377 |
| Fax |
|
| Email |
swapnilkeshav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinod Kumar Verma |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Department Of Anaesthesiology And Critical Care Medicine, I.G.I.M.S, Patna
Patna
BIHAR
800014
India |
| Phone |
9473191825 |
| Fax |
|
| Email |
drvvinodv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
Sheikhpura, Patna, 800014 |
| 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 |
| Swapnil Keshav |
Indira Gandhi Institute of Medical Sciences, Patna |
Department of Anaesthesiology And Critical Care Medicine, 1st Floor, Ward block,I.G.I.M.S,Sheikhpura, Patna
Patna
BIHAR |
9576515377
swapnilkeshav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, I.G.I.M.S, PATNA |
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 |
Conventional methods of airway assessment |
The study will evaluate the correlation between ultrasonography guided and conventional methods of airway assessment. |
| Intervention |
Use of Ultrasound as a precise tool for airway assessment. |
This study compares the Ultrasonography guided and conventional methods of airway assessment and will evaluate the usefulness of Ultrasound for better assessment of airway. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA physical status Ι to Ш.
2.Patients posted for elective surgery under general anaesthesia.
3.Patients willing to participate. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patients with BMI over 40 kg/m2.
3.Patients with pre-existing airway malformation/pathology.
4.Patients with facial or cervical fracture.
5.Patients with large goitre or cervical tumour.
6.Patients with previous history of difficult intubation.
7.Pregnant females
8.Patients with restricted mouth opening or neck movement.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| US-DSE values for all the patients and the number of intubations |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of difficult intubations predicted by the conventional methods |
time of intubation |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
31/03/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
plan to publish on completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to correlate ultrasonography guided method and the conventional methods for assessment of airway and Cormack-Lehane grading in adult patients undergoing elective surgeries under general anaesthesia ,to predict the ease or difficulty in endotracheal intubation . |