FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052532 [Registered on: 11/05/2023] Trial Registered Prospectively
Last Modified On: 29/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational 
Study Design  Other 
Public Title of Study   Comparison of two anatomical landmark techniques for predicting difficult airway in patients undergoing cancer surgeries 
Scientific Title of Study   A Prospective observational study to determine the role of Ratio of Height to Thyromental Distance(RHTMD) and Ratio of Height to Sternomental Distance(RHSMD) in predicting difficult airway in patients undergoing elective oncosurgeries under general anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepthi J Prabhu 
Designation  Associate professor 
Affiliation  Regional Cancer Centre 
Address  Department of Anaesthesiology Regional Cancer Centre Thiruvananthapuram

Thiruvananthapuram
KERALA
695019
India 
Phone  9895006045  
Fax    
Email  drdeepthiprabhu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepthi J Prabhu 
Designation  Associate professor 
Affiliation  Regional Cancer Centre 
Address  Department of Anaesthesiology Regional Cancer Centre Thiruvananthapuram


KERALA
695019
India 
Phone  9895006045  
Fax    
Email  drdeepthiprabhu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepthi J Prabhu 
Designation  Associate professor 
Affiliation  Regional Cancer Centre 
Address  Department of Anaesthesiology Regional Cancer Centre Thiruvananthapuram


KERALA
695019
India 
Phone  9895006045  
Fax    
Email  drdeepthiprabhu@gmail.com  
 
Source of Monetary or Material Support  
REGIONAL CANCER CENTRE,TRIVANDRUM 
 
Primary Sponsor  
Name  Nil 
Address  Not applicable 
Type of Sponsor  Other [] 
 
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 Deepthi J Prabhu  Regional Cancer Centre  Department of Anaesthesiology,Regional Cancer Centre Medical college kumarapuram road,Medical college campus,chalakkuzhi,695011
Thiruvananthapuram
KERALA 
9895006045

drdeepthiprabhu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status 1,2
undergoing elective oncosugeries under general anaesthesia 
 
ExclusionCriteria 
Details  Restricted neck mobility
Major airway abnormalities
Tumors or mass in the neck or airway
Post burn neck contractures
Pregnancy
Kyphoscoliosis
Obesity(BMI >30) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Predicts difficult airway, can avoid intraop unanticipated difficult airway related complications  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Predicts difficult airway  6 months 
 
Target Sample Size   Total Sample Size="193"
Sample Size from India="193" 
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)   15/05/2023 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

On  the preoperative day, patient’s airway will be assessed, which includes Mallampatti grading, Thyromental Distance, Sternomental Distance, height,weight, neck mobility. Ratio of  height to thyromental distance ( RHTMD)and ratio of height to sternomental distance (RHSMD)will be calculated. In the operation theatre, the baseline vitals of the patient like spo2,PR, BP,ECG will be recorded.Then patients will receive premedication with midazolam and Glycopyrrolate followed by preoxygenation with 100% oxygen.Anesthesia will be induced with propofol 1- 2mg/kg and muscle relaxation with vecuronium 0.1mg/kg as done routinely. Intubation will be carried out by an anesthesiologist with more than 5 years experience and who is blinded to the study.The glottis exposure on direct laryngoscopy will be graded as per routine. Intubation will be considered difficult if view on laryngoscopy is Cormack Lehane 3 or 4, >3 attempts at intubation, duration > 10min,or if stylets,bougie, video laryngoscopy or fibreoptic bronchoscope used.The preoperative airway assessment data and findings during intubation will be assessed and correlated to establish the incidence of difficult intubation. The ability of RHTMD and RHSMD to predict difficult airway preoperatively in patients actually     found to have difficult laryngoscopy and intubation will also be studied.


 
Close