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CTRI Number  CTRI/2020/11/029379 [Registered on: 26/11/2020] Trial Registered Prospectively
Last Modified On: 05/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective observational 
Study Design  Other 
Public Title of Study   A study to evaluate if a bedside ultrasound can help in predicting difficult airway 
Scientific Title of Study   Can Point of care ultrasound predict the difficulty in intubation: A prospective observational 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 Roopali Phulli 
Designation  Academic Junior Resident in Department of Anaesthesia 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  4th Floor A-block OT Complex Department of Anaesthesia AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8850819472  
Fax    
Email  roopali2693@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samarjit Dey 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  4th Floor A-Block,OT-Complex Department of Anaesthesia,Critical Care and Pain Medicine AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8014910806  
Fax    
Email  drsamar0002@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Roopali Phulli 
Designation  Academic Junior Resident in Department of Anaesthesia 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  4th Floor OT Complex A-Block Department of Anesthesia, AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8850819472  
Fax    
Email  roopali2693@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur  
 
Primary Sponsor  
Name  AIIMS Raipur 
Address  Department of Anaesthesia, critical care and pain medicine 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roopali Phulli  All India Institute of Medical Sciences, Raipur  OT Complex, A-Block, 4th Floor
Raipur
CHHATTISGARH 
8850819472

roopali2693@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe, AIIMS Raipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R68||Other general symptoms and signs, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable, no drug is used in the study.  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  elective surgeries
ASA 1 and 2
BMI 18.5- 29.9 
 
ExclusionCriteria 
Details  patients refusal
ASA 3 and 4
interincisor gap <3cm
loose teeth edentulous
TMD<6 cm
history of previous difficult intubation
BMI>30
patients requiring RSI
uncooperative
pregnant patients
patients with altered level of conciousness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of various ultrasound measurements of upper airway in
predicting difficult laryngoscopy and intubation preoperatively


To observe whether correlation exist between different preoperative ultrasound
parameters and Intubation difficulty scale (IDS). 
The data obtained will be analysed once the study is over and a relation between the ability of ultrasound to predict a difficult intubation will be compared with actual difficult intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To observe whether correlation exist between different preoperative ultrasound
parameters and Intubation difficulty scale (IDS). 
After intubation is over 
 
Target Sample Size   Total Sample Size="190"
Sample Size from India="190" 
Final Enrollment numbers achieved (Total)= "190"
Final Enrollment numbers achieved (India)="190" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2020 
Date of Study Completion (India) 01/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/10/2021 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Unpredictable difficult airway remains a primary concern for anaesthesiologists. Inaccurate assessment may place the patient at risk of hypoxic events  and even death if complications occur and appropriate ventilation cannot be maintained. Therefore accurate airway assessment should be performed for proper
planning and management of unexpected difficult intubations .The incidence of difficult laryngoscopy and tracheal intubation still remains 1.5-13% due to poor reliability of traditional protocols, algorithms and combination of screening tools in identifying a potentially difficult airway.The commonly used screening tests like Modified Mallampatti Classification, interincisor gap, thyromental distance, neck extension, jaw protusion have shown low sensitivity and specificity with limited predictive value. 

Ultrasound, due to its portable, non invasive characteristics, is useful bedside tool for airway assessment and is now widely available in operating rooms, emergency departments and criticalcare units. As the role of ultrasound in anaesthesia related airway assessment is encouraging but poorly defined , we have planned to assess its efficacy in predicting unanticipated difficult airway. A scoring system that can reliably assess difficult intubation is Intubation Difficulty Scale, which is done by direct laryngoscopy. However, laryngoscopy being an invasive procedure is difficult to perform in an awake patient, and cannot be used to predict difficult intubation.To our knowledge no study has been done to find the co relation between different preoperative ultrasound parameters and Intubation difficultyscale (IDS), hence the proporsal for this study for consideration.
 
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