| CTRI Number |
CTRI/2025/07/090692 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Sniffing versus RAMP position for tracheal
intubation using direct laryngoscopy in
anticipated difficult airway: a comparative
randomized prospective study |
|
Scientific Title of Study
|
Sniffing versus RAMP position for tracheal
intubation using direct laryngoscopy in
anticipated difficult airway :
A comparative,randomized ,prospective study
|
| 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 Vikramji Jashuji Thakor |
| Designation |
Resident doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College Baroda |
| Address |
Resident doctor Department of Anesthesia, Government Medical College, Baroda
Vadodara GUJARAT
Vadodara
GUJARAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9725889809 |
| Fax |
|
| Email |
vkthakor1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Afroza N. Syed |
| Designation |
Associate Professor (HG) |
| Affiliation |
Government Medical College, Baroda Vadodara GUJARAT |
| Address |
Department of Anaesthesiology, Goverment Medical College,SSG Hospital
BARODA
Vadodara
GUJARAT
390001
India |
| Phone |
9825359856 |
| Fax |
|
| Email |
afroza7887@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikramji Jashuji Thakor |
| Designation |
Resident doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College, Baroda Vadodara GUJARAT |
| Address |
Resident doctor Department of Anesthesia, Government Medical College, Baroda
Vadodara GUJARAT
Vadodara
GUJARAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9725889809 |
| Fax |
|
| Email |
vkthakor1989@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medical college baroda |
| Address |
Medical College Baroda Vinoda Bhave Road Anandpura Vadodara Pin code
390001 |
| 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 vikramji jashuji Thakor |
Government Medical College, Baroda Vadodara GUJARAT |
Department of Anesthesia, Government Medical College Baroda Vadodara GUJARAT Vadodara GUJARAT 390001 India
Vadodara
GUJARAT
390001
India
Vadodara
GUJARAT |
9725889809
vkthakor1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical& health research, government medical college barod |
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 |
RAMP position |
RAMP up position will be achieved by non-compressible 7 cm pillow kept under the head and shoulder of the patient as shown so that to make Sternal notch and external auditory meatus of the patient lie in horizontal line , which will be determined objectively by the Spirit ampoule Scale assembly.
Total duration of this intervention will be within 5 to 10 minute.
|
| Intervention |
Sniffing position |
Sniffing Position will be achieved by placing a standard 7 cm height non- compressible pillow under the patient’s head to achieve flexion of the neck and extension at the atlanto occipital joint .Total duration of this intervention will be within 5 to 10 minute. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged 20-65 years of either gender who will be admitted in SSG hospital for surgery under general anesthesia requiring orotracheal intubation .
Able to understand study procedure and give consent .
Mild to moderate difficult airway as per SARI score . |
|
| ExclusionCriteria |
| Details |
Refusal by patient to participate in study
Body mask index more than 35
Pregnant female
Facial trauma or polytrauma or cervical spine pathology
airway obstruction or oro nasal pathology
Mouth opening less than 1.5 finger
Active Respiratory illness
ASA grade ASA IV and ASA V |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses intubation time |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 ) Cormack lehane grading system
2 ) Repositioning of the patient & external larryngeal manipulation or burp maneuver
3 ) Alternative technique used or not |
In base line time |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/08/2025 |
| 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="0"
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
|
The primary objective of our study to asses the intubation time and to asses cormck lehane grading system and reposition of the patient or external laryngeal manipulation or BURP maneuver or alternative technique using including an excluding criteria . We will randomise patient according to compurer generated number We will give both sniffing position and RAMP position . in sniffing position we will place 7 cm non comprecible pillow under patient head and in RAMP position we will kept 7 cm non comprecible pillow under patient shoulder so that patient sternal notch and exter auditory meatus lie in horizontal plane . proposed advantage of this study is RAMP position can be better than sniffing position to improve the intubation time in difficult airway patient using direct laryngoscope with macintosh blade |