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CTRI Number  CTRI/2018/01/011333 [Registered on: 15/01/2018] Trial Registered Retrospectively
Last Modified On: 28/03/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective observational analytical study 
Study Design  Single Arm Study 
Public Title of Study   Airway assessment by ultrasound 
Scientific Title of Study   Ultrasonographic assessment of airway and its correlation with Cormack-Lehane grading - a prospective observational study 
Trial Acronym  No acronym 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VijayalakshmiSivapurapu 
Designation  Assistant Professor 
Affiliation  IndiraGandhiMedical college and Research Institute 
Address  Department of Anesthesiology Indira Gandhi Medical College & Research Institute Kadirkamam Pondicherry

Pondicherry
PONDICHERRY
605009
India 
Phone  09442176549  
Fax    
Email  prerana10@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  VijayalakshmiSivapurapu 
Designation  Assistant Professor 
Affiliation  IndiraGandhiMedical college and Research Institute 
Address  Department of Anesthesiology Indira Gandhi Medical College & Research Institute Kadirkamam Pondicherry

Pondicherry
PONDICHERRY
605009
India 
Phone  09442176549  
Fax    
Email  prerana10@yahoo.com  
 
Details of Contact Person
Public Query  
Name  VijayalakshmiSivapurapu 
Designation  Assistant Professor 
Affiliation  IndiraGandhiMedical college and Research Institute 
Address  Department of Anesthesiology Indira Gandhi Medical College & Research Institute Kadirkamam Pondicherry

Pondicherry
PONDICHERRY
605009
India 
Phone  09442176549  
Fax    
Email  prerana10@yahoo.com  
 
Source of Monetary or Material Support  
Indira Gandhi Medical College & Research Institute, Kathirkamam, Puducherry 605009 
 
Primary Sponsor  
Name  Indira Gandhi Medical College Research Institute 
Address  Kathirkamam, Pondicherry 605009 
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 
Vijayalakshmi Sivapurapu  Indira Gandhi Medical College & Research Institute  Department of Anesthesiology, Operation Theatre Complex, Kathirkamam, Pondicherry 605009
Pondicherry
PONDICHERRY 		 9442176549

prerana10@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, Indira Gandhi Medical College & Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All American Society of Anaesthesiologists grade I - III patients coming for endotracheal tube controlled general anaesthesia 
 
ExclusionCriteria 
Details  Pregnant patients, patients with cervical spine injuries, or maxillo-facial injuries or facial fractures, patients with oropharyngeal or laryngeal carcinoma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Correlation between preoperative ultrasound airway measurements and intraoperative laryngoscopic Cormack-Lehane Grade  At the time of intubation of airway at induction of anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
Final Enrollment numbers achieved (Total)= "396"
Final Enrollment numbers achieved (India)="396" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/02/2015 
Date of Study Completion (India) 01/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No publication as yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Ultrasonographic assessment of airway has a potential to identify and thereby help predict difficult airway with better accuracy than conventional assessment. The anaesthesiologist would be able to adequately plan and prepare for an expected difficult airway. 
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