FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/05/019065 [Registered on: 13/05/2019] Trial Registered Prospectively
Last Modified On: 10/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To compare two different positions of head and neck in view of easy visibility of vocal cords and ease of intubation in patients requiring general anaesthesia for elective surgeries . 
Scientific Title of Study   Evaluation of intubating conditions during direct laryngoscopy using sniffing position and simple head extension. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrGURPREET SINGH 
Designation  Professor,Department of Anaesthesiology 
Affiliation  GGS Medical College and Hospital,FARIDKOT 
Address  Department of Anaesthesiology,Guru Gobind Singh Medical College and Hospital,Faridkot,Punjab

Faridkot
PUNJAB
151203
India 
Phone  9216419871  
Fax    
Email  drgurpreetsinghggsmch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrGURPREET SINGH 
Designation  Professor,Department of Anaesthesiology 
Affiliation  GGS Medical College and Hospital,FARIDKOT 
Address  Department of Anaesthesiology,Guru Gobind Singh Medical College and Hospital,Faridkot,Punjab


PUNJAB
151203
India 
Phone  9216419871  
Fax    
Email  drgurpreetsinghggsmch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr RUPINDER KAUR 
Designation  PG student,Department of Anaesthesiology 
Affiliation  GGS Medical College and Hospital,FARIDKOT 
Address  Department of Anaesthesiology,Guru Gobind Singh Medical College and Hospital,Faridkot,Punjab

Faridkot
PUNJAB
151203
India 
Phone  8557048234  
Fax    
Email  rupybaidwan@yahoo.com  
 
Source of Monetary or Material Support  
Guru Gobind Singh Medical College and Hospital,Faridkot,Punjab 151203 
 
Primary Sponsor  
Name  Guru Gobind Singh Medical College and Hospital Faridkot 
Address  Guru Gobind Singh Medical College and Hospital ,Faridkot,Punjab 151203 
Type of Sponsor  Government 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 
Dr Gurpreet Singh  GGS Medical College and Hospital,Faridkot  Department of Anaesthesiology,Second floor,main operation theatre .
Faridkot
PUNJAB 
9216419871

drgurpreetsinghggsmch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Guru Gobind Singh Medical College, Faridkot, Punjab  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: C50||Malignant neoplasm of breast, (3) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Simple Head extension   to evaluate the ease of intubation and glottic visualization during direct laryngoscopy using simple head extension 
Intervention  Sniffing Position   To evaluate the ease of intubation and glottic visualization during direct laryngoscopy using sniffing position  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Age group between 20-50 years.
2)ASA grade I and II.
3)Patients scheduled to undergo surgery under general anaesthesia
 
 
ExclusionCriteria 
Details  1)Patients with body mass index more than 30 kg/m2
2)Restricted neck movements.
3)Bucked teeth
4)Thyromental distance less than 65mm.
5)Limitation of anterior and posterior movement of mandible.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate and compare glottic visualization using sniffing position and simple head extension during direct laryngoscopy.
2.To evaluate and compare ease of intubation using sniffing position and simple head extension during direct laryngoscopy.

 
Modified Cormack And Lehane Classification for glottic visualization
Grade 1: Full view of glottis seen.
Grade 2a: Partial view of glottis seen.
Grade 2b: Only the posterior extremity of the glottis seen.
Grade 3: Only epiglottis seen.
Grade 4: Neither glottis nor epiglottis seen.

To assess difficulty in intubation, Intubation Difficulty Scale consisting of seven parameters will be used:
Intubation difficulty Scale (IDS)




 
 
Secondary Outcome  
Outcome  TimePoints 
To compare sympathetic response in sniffing position and simple head extension during direct laryngoscopy.
 
 
Sympathetic stimulation in terms of heart rate and mean arterial blood pressure will be noted
1)5 minutes before induction 2)at the time of laryngoscopy 3)5 minutes after laryngoscopy
4) 10 minutes after laryngoscopy.

 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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 1 
Date of First Enrollment (India)   13/05/2019 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

EVALUATION OF INTUBATING CONDITIONS DURING DIRECT LARYNGOSCOPY USING SNIFFING POSITION AND SIMPLE HEAD EXTENSION


Introduction: Tracheal intubation remains one of the commonest means of establishing an airway and the ability to maintain a good glottic visualization during direct laryngoscopy is the major determinant of ease of intubation. Sniffing position and simple head extension are the two positions used in direct laryngoscopy done for tracheal intubation in patients requiring general anaesthesia.

 

Aims and Objectives:1)To evaluate and compare glottic visualization using sniffing position and simple head extension during direct laryngoscopy.2)To evaluate and compare ease of intubation using sniffing position and simple head extension during direct laryngoscopy .3)To compare sympathetic response in sniffing position and simple head extension during direct laryngoscopy.

 

Material and Methods: The study will be conducted in Department of Anaesthesiology, GGS Medical College, Faridkot. Inclusion Criteria:1.Age group between 20-50 years. 2. ASA Grade I and II.3. Patients scheduled to undergo surgery under general anaesthesia. Exclusion Criteria: 1. Patients with body mass index more than 30 kg/m22.Restricted neck movements.3.Bucked teeth 4.Thyromental distance less than 65mm. 5.Limitation of anterior and posterior movement of mandible. Written informed consent will be obtained from each patient. 220 patients scheduled for elective surgeries under general anaesthesia at department of anaesthesia, GGSMCH, Faridkot will be randomly assigned to one of two groups. In Group I patients, laryngoscopy will be done in sniffing position and in Group II patients, laryngoscopy will be done in simple head extension. Glottic visualization will be assessed by Modified Cormack and Lehane classification and ease of tracheal intubation will be assessed by Intubation Difficulty Scale. Also laryngoscopic sympathetic response will be assessed by means of heart rate and mean arterial blood pressure.

 
Close