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CTRI Number  CTRI/2024/03/064929 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The study is based on the glottis view in different positions like sniffing position and 25 degree backup position, during intubation in patient undergoing general anaesthesia.  
Scientific Title of Study   A Comparative Study of Glottic Visualisation and ease of intubation between sniffing position and 25 degree backup position in adult patients undergoing General Anaesthesia  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhirami G 
Designation  Post graduate student  
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology, Bangalore medical college and research institute, K R Market , Bangalore .

Bangalore
KARNATAKA
560002
India 
Phone  8904215031  
Fax    
Email  Abhiramighyr13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramachandraiah R 
Designation  Professor  
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology, Bangalore medical college and research institute, K R Market , Bangalore .

Bangalore
KARNATAKA
560002
India 
Phone  8904215031  
Fax    
Email  ramachandraiah090@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ramachandraiah R 
Designation  Professor  
Affiliation  Bangalore Medical College and Research Institute  
Address  Department of Anaesthesiology, Bangalore medical college and research institute, K R Market , Bangalore .

Bangalore
KARNATAKA
560002
India 
Phone  8904215031  
Fax    
Email  ramachandraiah090@gmail.com  
 
Source of Monetary or Material Support  
Bangalore medical college and research institute  
 
Primary Sponsor  
Name  Abhirami G 
Address  Post graduate, Department of Anaesthesiology, Bangalore medical college and research institute, K R Market, Bangalore 560002 
Type of Sponsor  Other [Self] 
 
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 Abhirami G  Bangalore Medical College and Research Institute   Major operation theatre , 3rd floor , MPB building, Victoria hospital, Bangalore, Karnataka
Bangalore
KARNATAKA 
8904215031

Abhiramighyr13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee BMCRI  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 
Intervention  Comparing the Glottic view and ease of intubation between sniffing and 25 degree backup position inducing intubation in adult patients undergoing general anaesthesia   Sniffing position being the stand position used during intubation which is compared with 25 degree backup position for glottis view and ease of intubation  
Comparator Agent  Comparing the Glottic view and ease of intubation between sniffing position and 25 degree backup position   Study group divided into two groups , group 1 intubated in sniffing position and group 2 intubated in 25 degree backup position, the glottis view and ease of intubation compared as per Cormack Lahane grading and intubation difficult scale respectively . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients who are giving consent for participating in the study undergoing general Anaesthesia  
 
ExclusionCriteria 
Details  Anticipated difficult airway like bucked teeth , restricted neck movements, inter incisor gap less than 35mm , limited mandibukar movement, risk of aspiration, pregnant women, obese patients  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Glottis view as per Cormack Lahane grading   During direct laryngoscopy  
 
Secondary Outcome  
Outcome  TimePoints 
Ease of intubation as per Intubation Difficult Scale   During Intubation  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 4 
Date of First Enrollment (India)   07/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="3" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 approval and clearance from the institutional ethics committee,  the patients fulfilling the inclusion criteria will be enrolled for the study, after  obtaining informed consent will be included in the study and divided  into two groups using computer generated randomization sequence. 

1.Group I = Sniffing position  

 2.Group II = 25â—¦ backup position  

All patients evaluated thoroughly in preoperative period for Mallampati grading, thyromental distance, Inter-incisor gap, Neck movements, Mandibular movement,  Pharyngeal pathology. All patients kept nil per oral overnight and premedicated with  alprazolam 0.5mg the previous night of surgery. After arriving at pre operative room  IV line secured and fluids connected. In operation theater Non-invasive blood pressure, Plethysmography, Electrocardiography connected. Before induction in Group  I (sniffing position) patients 8cm head ring placed under head in supine position. All  patients will be premedicated, preoxygenated, induced as per institutional protocol. At  time of Direct laryngoscopy using size 3 Macintosh blade, in Group I patients head  will be extended at atlanto-occipital joint maximally, in Group II patients 25-degree backup position will be given at torso at level of hip. Glottic visualization during  laryngoscopy assessed by Cormack and Lehane grading and Ease of intubation will be assessed by Intubation Difficulty Scale (IDS)

 
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