| 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
|
|
|
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
|
|
|
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. |