| CTRI Number |
CTRI/2020/08/027487 [Registered on: 31/08/2020] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
how to know the difficulty of putting a tube in your throat during operation by using ultrasound |
|
Scientific Title of Study
|
Evaluation of airway ultrasound parameters in predicting difficult airway: A Prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/AIIMS BBSR/PG THESIS/2020-21/42 |
Protocol Number |
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparajita panda |
| Designation |
Associate professor,Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Academic block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9438884118 |
| Fax |
|
| Email |
anaes_aparajita@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aparajita panda |
| Designation |
Associate professor,Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Academic block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar
ORISSA 751019 India |
| Phone |
9438884118 |
| Fax |
|
| Email |
anaes_aparajita@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Sambit Nandi |
| Designation |
Junior Resident, Academic,Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
PG-3 hostel, Aiims residential campus, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
7809425800 |
| Fax |
|
| Email |
nandi.sambit@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Dr Aparajita Panda |
| Address |
Academic Block, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, PIN 751019 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aparajita Panda |
Department of Anaesthesiology, All India Institute of Medical Sciences, Bhubaneswar |
Sijua, Patrapada, Bhubaneswar, PIN 751019 Khordha ORISSA |
9438884118
anaes_aparajita@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: B||Imaging, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65 years who require tracheal intubation for elective surgery under general anaesthesia
2.ASA grade 1,2 and 3
|
|
| ExclusionCriteria |
| Details |
1.Refusal to consent
2.Patients planned for fiberoptic intubation
3.Patients in whom USG neck is not feasible
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Co-relation between the sonographic measurements of anterior cervical soft tissue thickness, tongue height to oral height ratio and Cormack-Lehane grade at direct laryngoscopy view in patients |
Preoperatively and intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine a cut off value for the above measurements
2.To determine the ease of obtaining USG parameters
|
preoperatively and intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| Date of Study Completion (India) |
30/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2022 |
|
Estimated Duration of Trial
|
Years="1" Months="10" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Airway assessment plays a key role during pre-anaesthetic assessment. Identifying difficult airway beforehand can help us in adequate preparation, selection of equipments , and participation of skilled persons during intubation. Airway assessment is usually done using different clinical parameters such as Body Mass Index (BMI), circumference of neck , Mallampati score, interincisior gap, sternomental distance, thyromental distance and neck mobility. These parameters are often used in combination so as to overcome their low sensitivity in predicting difficult airway. Incidence of unanticipated difficult airway stands at 1%-8% in spite of using multiple screening tools. Moreover, in case of unconscious and uncooperative patients, clinical tools have limited use. To overcome the above limitations of clinical airway assessment tools, there is a need to develop an accurate airway assessment tool. Ultrasonography, being simple, portable, bed-side, non-invasive and non-ionizing tool, has been proposed recently as an aid for airway assessment and predicting difficult laryngoscopy. Various ultrasonographic measurements i.e. distance between skin and hyoid bone, distance from skin to thyrohyoid membrane, skin to epiglottis distance , distance from skin to vocal cord have been used for this purpose. To the best of our knowledge the data from previous studies are inconclusive, also the data from Indian population is not so robust. Therefore, we are planning to conduct the current study while including a novel ultrasonographic parameter i.e. tongue thickness to oral height ratio in assessing difficult airway. |