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CTRI Number  CTRI/2024/04/065544 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A clinical trial to compare the laryngoscopic vision of vocal cords in two positions, ramp position and conventional sniffing position during endotracheal intubation. 
Scientific Title of Study   A prospective comparative study of laryngoscopic vision of vocal cords in ramp position and conventional sniffing position during endotracheal intubation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VAISHNAVI S S 
Designation  JUNIOR RESIDENT 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS HOSPITAL, MYSORE, KARNATAKA.

Mysore
KARNATAKA
570004
India 
Phone  8111829328  
Fax    
Email  ssvaishnavi95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr VYSHNAVI S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANESTHESIOLOGY, JSS HOSPITAL, MYSORE, KARNATAKA.

Mysore
KARNATAKA
570004
India 
Phone  9880110022  
Fax    
Email  vyshgiri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr VYSHNAVI S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANESTHESIOLOGY, JSS HOSPITAL, MYSORE, KARNATAKA.

Mysore
KARNATAKA
570004
India 
Phone  9880110022  
Fax    
Email  vyshgiri@gmail.com  
 
Source of Monetary or Material Support  
JSS MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  JSS MEDICAL COLLEGE AND HOSPITAL, MYSORE 
Type of Sponsor  Private medical college 
 
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 
VAISHNAVI S S  JSS MEDICAL COLLEGE AND HOSPITAL  Patients of ENT,ORTHOPEDICS, NEUROSURGERY,GENERAL SURGERY, GASTROSURGERY, posted for elective surgery under general anesthesia, OT complex, JSS HOSPITAL, MG road, AGRAHARA.
Mysore
KARNATAKA 
8111829328

ssvaishnavi95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Medical College, JSS Academy of Higher Education and Research, Institutional Ethical 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  Laryngoscopy in ramp position  Modified Cormack Lehane grading will be noted during laryngoscopy during ramp position 
Intervention  Laryngoscopy in sniffing position  Modified Cormack Lehane grading will be noted during laryngoscopy in sniffing position 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18-60 years.
Either sex.
ASA status 1 and 2.
Patients undergoing surgery under general anesthesia which require oral intubation. 
 
ExclusionCriteria 
Details  ASA status 3 and above.
Patients with unstable cervical spine and spine abnormalities.
Patients who require rapid sequence intubation aor awake intubations.
Gross facial abnormalities.
Orofacial injuries.
Nasal intubations. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the larngoscopic vision of vocal cord in ramp position and conventional sniffing position during endotracheal intubation by assessing Modified Cormack Lehane scale.  Starting from patient positioning for endotracheal intubation till 5 minutes after completion of endotracheal intubation.  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the ease of intubation by need for use of external laryngeal maneuvre & airway adjunct devices
To assess the association between Modified Cormack Lehane grading, Mallampatti score & neck circumference in deciding the difficulty in intubation.  
Starting from patient positioning for intubation till 5 minutes after completion of endotracheal intubation. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/04/2024 
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="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  

After obtaining Ethics Committee approval and written informed consent from the patients, those patients included in ASA physical class I-II in the age group of 18-60 years of either sex undergoing elective surgery under general anesthesia requiring endotracheal intubation is selected for the study.

 Pre anaesthetic evaluation of the patient posted for surgery will be conducted on the day before surgery and pre-anesthetic orders will be given. The patient’s BMI, Mallampati Score, Thyromental distance and Neck circumference will be noted. The patients will be divided into two groups, Group S and Group R.

 On the day of the surgery, inside the operation theatre, monitoring of Oxygen saturation, heart rate, non invasive blood pressure will be done. A patent IV cannula will be provided and IV fluids will be started for fluid management. Patient will be preoxygenated with 100% oxygen for 3 minutes, premedicated with Inj MIDAZOLAM 0.01mg/kg, Inj GLYCOPYRROLLATE 0.01 mg/kg and Inj FENTANYL 2mg/kg. Patient will be induced with Inj PROPOFOL 2mg/kg and muscle relaxant Inj VECURONIUM 0.1mg/kg will be given. For the first group (Group S), laryngoscopy will be done in “sniffing position” first and Cormack Lehane grade will be noted, after which table position will be changed to get a “ramp position” measuring 500+/-60 angle using protractor, the end point being  the external auditory meatus and sternal notch are in horizontal line. This will be confirmed by using the Scale Ampoule Method where a transparent ampoule will be plastered to a long metallic scale and held between EAM and sternal notch. The table elevation and head end flattening, after the initial lift to 50 degree will be adjusted such that the bubble in the ampoule comes to lie in the centre. Modified  Cormack lehane grading will be noted in this position again. For the next group (GroupR) , laryngoscopy will be done in RAMP position first and in sniffing position later. The endotracheal tube of appropriate size will be inserted and during the process the ease with which tube is passed will be assessed, by assessing the need for any external manuevres or use of adjunct devices like style or bougie. The position of the ET tube will be confirmed with 5 point auscultation and capnography.

In case the intubation is difficult in either of the positions, a switch will be made to the other position. If intubation is still difficult after change in position, call for help and difficult irway algorithm will be initiated assuming  an unanticipated difficult airway scenario.

 
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