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CTRI Number  CTRI/2024/09/074198 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 16/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Interventional]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparative study between different head positions to assess the difficulty in intubation  
Scientific Title of Study   A Randomized Comparative Study of the Sniffing Position with Simple Head Extension for Visualization of Glottis and Difficulty in Intubation during Direct Laryngoscopy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meghana P 
Designation  Post Graduate 
Affiliation  Rajarajeshwari Medical College and Hospital  
Address  Department of Anaesthesiology,Rajarajeswari Medical college and Hospital,Mysore Road,Kambipura,Bangalore Bangalore KARNATAKA 560074 India Bangalore KARNATAKA 560074 India

Bangalore
KARNATAKA
560074
India 
Phone  9945228822  
Fax    
Email  meghana948@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sowmya M Jois  
Designation  Associate Professor  
Affiliation  Rajarajeswari Medical college and Hospital 
Address  Department of Anaesthesiology,Rajarajeswari Medical college and Hospital,Mysore Road,Kambipura,Bangalore Bangalore KARNATAKA 560074 India Bangalore KARNATAKA 560074 India

Bangalore
KARNATAKA
560074
India 
Phone  9980891082  
Fax    
Email  Drsowmyasharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sowmya M Jois  
Designation  Associate Professor  
Affiliation  Rajarajeswari Medical college and Hospital 
Address  Department of Anaesthesiology,Rajarajeswari Medical college and Hospital,Mysore Road,Kambipura,Bangalore Bangalore KARNATAKA 560074 India Bangalore KARNATAKA 560074 India

Bangalore
KARNATAKA
560074
India 
Phone  9980891082  
Fax    
Email  Drsowmyasharma@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,Rajarajeswari Medical college and Hospital,Mysore Road,Kambipura,Bangalore Bangalore KARNATAKA 560074  
 
Primary Sponsor  
Name  Rajarajeshwari Medical College and Hospital  
Address  202, Mysore Road, Kengeri Satellite Town, Kambipura, Karnataka 560074 
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 
Dr Meghana P  Rajarajeswari Medical college and Hospital  2nd floor hospital building, Department of Anaesthesiology,Rajarajeswari Medical college and Hospital,Mysore Road, Kambipura,Bangalore KARNATAKA 560074 India
Bangalore
KARNATAKA 
9945228822

meghana948@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional 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  Group SHE, Patients intubated with simple head extension  In the simple head extension group, no headrest will be placed under the head; however, maximal head extension will given at the time of laryngoscopy 
Intervention  Group SP, Patients intubated with sniffing position  In Sniffing position group, an incompressible head ring will be placed under the head to raise its height by 7 cm from the neutral plane followed by maximal extension of the head 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.ASA I and II patients of either sex.
2.Patients aged between 18 to 50 years.
3.Patients undergoing elective surgeries under general anesthesia with endotracheal intubation.
4.Patients willing to participate in this study. 
 
ExclusionCriteria 
Details  1.Patients not willing to participate in this study
2.Patients with ASA grades III or IV
3.Patients undergoing emergency surgeries
4.Patients undergoing Rapid sequence induction
5.Anomalies of face, nose , mouth and temporomandibular joint
pathology, burns and contracture short neck, beard or cervical spondylosis
6.Interincisor gap was less than 3cm on mouth opening
7.Body mass index in more than 30 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary aim of this study is to compare the sniffing position with simple head extension for visualisation of glottis and difficulty in intubation during direct laryngoscopy  0 seconds , 15 seconds  
 
Secondary Outcome  
Outcome  TimePoints 
Compare both groups also with regard to the incidence of difficult mask ventilation & difficult laryngoscopy, difficult intubation, & variables of the IDS, time taken to intubate & the stance adopted by the anaesthesiologist performing laryngoscopy & tracheal intubation  0 seconds, 15 seconds  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/10/2024 
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="6"
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  

Tracheal intubation remains one of the commonest means of establishing an airway. Alignment of laryngeal axis, pharyngeal axis, and oral axis during direct laryngoscopy causes line of vision for better visualization of glottis which is usually achieved in sniffing position. Simple head extension is also considered superior to sniffing position where significant number of patients intubated in the Sniffing position required more than one operator, external laryngeal manipulation, and use of increased force during laryngoscopy compared to those intubated through simple head extension. In this study we will determine the differences between the sniffing position and the simple head extension position with regard to the incidence of difficult mask ventilation and difficult laryngoscopy, difficult intubation, and variables of the IDS, time taken to intubate and the stance adopted by the anaesthesiologist performing laryngoscopy and tracheal intubation in adult patients undergoing elective surgery under general anaesthesia with muscle paralysis.

 
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