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
|
|
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
|
|
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. |