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CTRI Number  CTRI/2025/05/087303 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To Know effectiveness of Physical Examination of Oral cavity , Neck and Ultrasound Examination of Neck to Predict Difficulty of placing Tube into Trachea for Giving General Anesthesia  
Scientific Title of Study   Difficult airway prediction using Clinical and Ultrasound airway assessment parameters:A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thamizhanban D 
Designation  Post Graduate Registrar 
Affiliation  Christrian Medical College 
Address  Department of Anesthesia Paul Brand Building (new) Christian Medical College hospital -Town campus Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8870463057  
Fax    
Email  thamsblack@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smitha Elizabeth George 
Designation  Professor 
Affiliation  Christrian Medical College 
Address  Department of Anesthesia Paul Brand Building (new) Christian Medical College hospital -Town campus Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9655820582  
Fax    
Email  smitha.lizgeorge@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Thamizhanban D 
Designation  Post Graduate Registrar 
Affiliation  Christrian Medical College 
Address  Department of Anesthesia Paul Brand Building (new) Christian Medical College hospital -Town campus Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8870463057  
Fax    
Email  thamsblack@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Research Office, Christrian Medical College, Bagayam, Vellore, Tamil Nadu, 632002 
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 Smitha Elizabeth George  Christian Medical college, Hospital  Christian Medical college, Hospital, ida Scuddar Road,Thottapalayam
Vellore
TAMIL NADU 
9655820582

smitha.lizgeorge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Research Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H701||Chronic mastoiditis, (2) ICD-10 Condition: K432||Incisional hernia without obstruction or gangrene, (3) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (4) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (5) ICD-10 Condition: C20||Malignant neoplasm of rectum, (6) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (7) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adults above 18yrs of age , classified as ASA1 and ASA 2 undergoing Elective Surgeries- Plastics Surgeries, Gynaecology Surgeries, Urology Surgeries, General Surgeries, Ortho Surgeries, ENT surgeries under General Anaesthesia in CMC Town Campus and Ranipet Campus requiring intubation for surgeries. 
 
ExclusionCriteria 
Details  Anticipated Difficult Airway-Pregnant women,Patients with known airway-Oral, pharyngeal, Laryngeal pathologies, Cervical Vertebral diseases, Large Thyroid and Parathyroid Swelling, Submandibular Salivary Gland Pathology, Healed Post Tracheostomy scar, Post Burn Contractures of Neck, or any scar over the neck and patients posted for Oro-Pharyngeo-Laryngeal procedures , Emergency surgeries,Mentally Challenged, Superspeciality Surgery – Neuro Surgery, Cardiothoracic Surgery are excluded from this study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Predictive Value of Ultrasound Airway Assessment in Difficult Airway   At time of Induction 
 
Secondary Outcome  
Outcome  TimePoints 
Predictive Value of Clinical Airway Assessment in Difficult Airway   At time of Intubation 
Comparison of Predictive Value of ultrasound Airway assessment with Clinical Airway Assessment for Difficult Airway Prediction  NIL 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
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)   02/06/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Difficult Airway Prediction is an important part of pre anaesthesia assessment as it facilitates planning and preparing to manage a difficult airway. This in turn will enable a smooth perioperative course and reduced perioperative morbidity. Conventional physical assessment for difficult airway can sometimes fail to identify a difficult airway. This has made Point of Care Ultrasonography (POCUS) as an evolving tool for airway assessment.

In this study, both Male and Female Patients above 18yrs of Age, Classified as per American Society of Anaesthesiologist as ASA1,ASA 2, posted for Elective Surgeries planned under General Anaesthesia using endotracheal intubation are included. Pregnant women, Patients with known airway (Oral, pharyngeal, Laryngeal) pathologies, Cervical Vertebral diseases, Large Thyroid and Parathyroid Swelling, Submandibular Salivary Gland Pathology, Healed Post Tracheostomy scar, Post Burn Contractures of Neck, or any scar over the neck and patients posted for Oro-Pharyngeo-Laryngeal procedures and Emergency surgeries are excluded from this study.

In this study, after consent for the study, the airway physical assessment using SARI scoring is evaluated preoperatively. Preoperatively (before Intubation) On the day of Surgery, in the operating room, the primary investigator or  co-investigator shall measure Distance from Skin to Epiglottis (DSE)and Hyomental Distance (HMD)  with neck neutral, extended and in ramped positions ,and tongue thickness (TT) using ultrasound, thus completing the tests in the DARES protocol. It is planned that 15% of Sample size  done by the Primary Investigator shall be validated by Radiologist – Co Investigator. . If the Primary investigator’s assessment is not comparable to Radiologist - Co Investigator, then patients assessed by Primary investigator prior shall be dropped and the Primary Investigator shall be undergoing further training with the co – investigator. Post Training Primary Investigator will continue the study.

The Senior Anaesthesiologist posted on the elective list who is not aware of  the recorded SARI score and DARES protocol measurements will intubate the patient and record the IDS score obtained.

POCUS predictive value in Difficult Airway Assessment using the DARES protocol, will be calculated and compared with conventional physical airway assessment using the SARI score The difficulty of  airway management will be calculated based on the IDS score.

 
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