FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087214 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   to compare changes of wind pipe opening in patients above 65 years,in their back elevated to 20 degrees and lying flat positions using camera. 
Scientific Title of Study   To compare the video laryngoscope Percentage of glottic opening view in supine and back elevated to 20 degree in patients above 65 years. 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  T R SUDHARSAN 
Designation  POST GRADUATE 
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORE 
Address  Department of Anesthesia Christian Medical college Vellore
Department of Anesthesia Christian Medical College Vellore
Vellore
TAMIL NADU
632004
India 
Phone  9659837577  
Fax    
Email  imsusa04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tony Thomson Chandy 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anesthesia Christian Medical College Vellore
Department of Anesthesia Christian Medical College Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162282105  
Fax    
Email  tonythomson@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Sudharsan 
Designation  Post graduate 
Affiliation  CHRISTIAN MEDICAL COLLEGE 
Address  Department of Anesthesia Christian Medical College Vellore
Department of Anesthesia Christian Medical College Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162282105  
Fax    
Email  imsusa04@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Christian Medical College Fluid Research Grant 
Address  Christian Medical College Thottapalayam Vellore 632004 
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 
T R SUDHARSAN  Operating Rooms  Department of Anesthesia Christian Medical College Vellore 632004
Vellore
TAMIL NADU 
9659837577

imsusa04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Review Board Ethics and Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C178||Malignant neoplasm of overlappingsites of small intestine, (2) ICD-10 Condition: K460||Unspecified abdominal hernia withobstruction, without gangrene, (3) ICD-10 Condition: L039||Cellulitis and acute lymphangitis,unspecified, (4) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age more than 65 years
Both Male and Female patients 
 
ExclusionCriteria 
Details  BMI more than 35
ASA 3 and 4
Cardiac surgery patients
Immobile cervical spine
Intra oral tumors
IID less than 2mm. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the difference in laryngoscopy view between supine and 20 degree back elevated position patients above 65 years  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the time for successful intubation in back up position  baseline 
To assess the attempts needed for successful endotracheal intubation  baseline 
To measure the decrease in oxygen saturation during intubation  baseline 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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="2"
Days="30" 
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  
Physiological and airway anatomical changes in the elderly challenges rapid securing the airway. Limited oxygen reserve, systemic and end organ comorbidities leads to increased morbidity and mortality during laryngoscopy and intubation in the elderly. Optimisation of the head and neck position improves laryngoscopic view and endotracheal intubation. The  sniffing position is forward flexion of cervical spine and head extension at the atlantooccipital joint aligns oropharyngeal and laryngeal axes. In the geriatric population, the glottis view is difficult due to restrictive changes at  atlantoaxial joint and cervical vertebrae mobility along with muscle tone and altered physiologic changes.  
Recent evidence suggests that positioning the patient prior to intubation with backup elevation compared to the classical sniffing position improves laryngeal inlet visualization. Therefore decreasing  time to intubation of the trachea thus preventing and minimizing the effects of hypoxia on the geriatric cerebral cognitive function along with prevention of myocardial ischemia. Similar studies has not explored the effectiveness of the backup position in the elderly population. This study proposes to compare the glottic opening views between supine and back up position in the same patient. 
 

 
Close