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CTRI Number  CTRI/2014/09/004960 [Registered on: 02/09/2014] Trial Registered Retrospectively
Last Modified On: 14/07/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to determine which is the better posture the patient should be lying in to get the better view in the laryngoscope (an instrument for inserting tube in the larynx or voice box) 
Scientific Title of Study   PROSPECTIVE RANDOMIZED CROSSOVER COMPARATIVE STUDY OF DIRECT LARYNGOSCOPIC VIEW IN SNIFFING AND 25 DEGREES BACKUP POSITION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajashree Agaskar 
Designation  Consultant Anesthesiologist  
Affiliation  Jaslok Hospital and Research Centre 
Address  Department of Anesthesiology Jaslok Hospital and Research Centre 15 Dr. G. Deshmukh Marg Mumbai

Mumbai
MAHARASHTRA
400026
India 
Phone  9820143148  
Fax    
Email  rdagaskar@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sadhana Srivastava 
Designation  Primary DNB trainee 
Affiliation  Jaslok Hospital and Research Centre 
Address  Department of Anesthesiology Jaslok Hospital and Research Centre 15 Dr. G. Deshmukh Marg Mumbai

Mumbai
MAHARASHTRA
400026
India 
Phone  9833620861  
Fax    
Email  sadhana.srivastava@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajashree Agaskar 
Designation  Consultant Anesthesiologist  
Affiliation  Jaslok Hospital and Research Centre 
Address  Department of Anesthesiology Jaslok Hospital and Research Centre 15 Dr. G. Deshmukh Marg Mumbai

Mumbai
MAHARASHTRA
400026
India 
Phone  9820143148  
Fax    
Email  rdagaskar@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anesthesia, Jaslok Hospital and Research Centre Mumbai. 
 
Primary Sponsor  
Name  Jaslok Hospital and Research Centre 
Address  15 Dr.G. Deshmukh Marg Mumbai 400026 
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 Rajashree Agaskar  Jaslok Hospital and Research Centre  department of anaesthesia, O.T. complex, 18th floor, jaslok hospital and research centre, 15 Dr. G. Deshmukh Marg Mumbai
Mumbai
MAHARASHTRA 
9820143148

rdagaskar@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Jaslok Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  direct laryngoscopic view and ease of intubation under general anaesthesia.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  25 Degrees Back Up Position  Direct laryngoscopy will be done in 25 Degrees Back Up Position and evaluation of modified Cormack Lehane grade. 
Comparator Agent  Sniffing Position  Direct laryngoscopy wil be done in Sniffing Position and evaluation of modified Cormack Lehane grade. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients scheduled to receive General Anaesthesia with endotracheal intubation.
2. ASA Grade I, II and III
3. Malampatti Classification I, II, III
4. Body Mass Index ( BMI) < 35 Kg/m2
5. Patients giving informed consent
 
 
ExclusionCriteria 
Details  1. Patients refusal
2. ASA Grade IV.
3. Malampatti Classification IV
4. Anticipated difficult airway.
5. Patients with loose teeth
6. Body mass index more than 35 Kg/m2
7. Patients with cervical spine disease
8. Condition requiring rapid sequence intubation.
9. Patients with severe cardiovascular disease.
10. Coagulopathy or patient on anticoagulant therapy.
11. Raised intracranial tension.
12. Pregnant females
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
laryngeal view (Modified Cormack Lehane Grade) during direct larngoscopy (L1 and L2) in sniffing and 25 degrees back up position  at the end of laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
Pillow height required to achieve optimal sniffing (external auditory meatus to sternal notch) position.
 
at the end of giving sniffing position
 
Intubation Difficulty Scale  after intubation 
 
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)   04/03/2014 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

With this study we want to evaluate whether laryngoscopic view is better in 25 degrees back up position as compared to sniffing position?  B. J. Lee et al in 2007 have shown that during laryngoscopy, the laryngeal view, as assessed by Percentage of glottis opening (POGO) scores, improves significantly in the 25 degrees back-up position when compared with the flat supine position. However 25 degrees back-up position has not been compared with the sniffing position which is standard of care for direct laryngoscopy. The aim of this study is to evaluate the effect of 25 degree back up position on laryngeal view compared with the sniffing position during direct laryngoscopy. The primary objective is to compare the laryngeal view in both positions by by modified Cormack – Lehane grading.  Secondary Objectives are to compare the laryngeal view in both positions after applying external laryngeal  pressure if necessary, to compare the difficulty in intubation with the help of Intubation Difficulty Scale(IDS)  and to find out the mode value of pillow height required to achieve optimal sniffing ( external auditory meatus to sternal notch ) position. 100 adult patients ASA I, II and III physical status posted for surgery under general anaesthesia with endotracheal intubation will be studied. A detailed preanaesthetic evaluation of airway will be performed which includes BMI, thyromental distance, interincisor gap and modified Mallampatti grading, and adequacy of neck movement. Patients will be randomized as Group S where intubation will be done in sniffing position and Group B where intubation will be done in 25 degrees backup position. Laryngoscopy will be performed in both positions in each patient followed by endotracheal intubation. Glottic visualization will be assessed by modified Cormack Lehane classification. Intubation Difficulty Scale (IDS) will assess the intubation difficulty.

 
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