| CTRI Number |
CTRI/2025/09/094813 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISION OF INTUBATION CHARACTERISTICS IN TWO DIFFERENT POSITIONS - RAMPED VERSUS SNIFFING USING VIDEO
LARYNGOSCOPE IN OBESE PATIENTS |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE STUDY OF RAMPED VERSUS SNIFFING POSITION IN TERMS OF INTUBATION CHARACTERSTICS DURING VIDEO LARYNGOSCOPY GUIDED INTUBATION IN OBESE PATIENTS AT SAWAI MAN SINGH MEDICAL COLLEGE JAIPUR. |
| 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 Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital |
| Address |
Department of Anaesthesia,Second Floor,OT Complex,Dhanvantri building,Sawai Man Singh Medical College and Attached Hospital,Jaipur,Rajasthan,302004,India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital |
| Address |
Department of Anaesthesia,Second Floor,OT Complex,Dhanvantri building,Sawai Man Singh Medical College and Attached Hospital,Jaipur,Rajasthan,302004,India
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paras Gupta |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital |
| Address |
Department of Anaesthesia,Second Floor,OT Complex,Dhanvantri Building,Sawai Man Singh Medical College and Attached Hospital,Jaipur,Rajasthan,302004,India
Jaipur
RAJASTHAN
302004
India |
| Phone |
7014295019 |
| Fax |
|
| Email |
theparasgupta245@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur, Pin code-302004,Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur |
| Address |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur, Pin code-302004,Rajasthan,India |
| 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 Mamta Sharma |
SMS Hospital Jaipur |
ENT OT, GENERAL SURGERY OY (OT2),
Department of Anaesthesia,Second floor,Dhanwantri building,
Sawai Man Singh Medical College and Attached Group of Hospitals,
Jaipur,
302004
Rajasthan
Jaipur
RAJASTHAN |
09829566077
drmamtasharma@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE ETHICS COMMITTEE, SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS, JAIPUR |
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 |
| Intervention |
Intubation in ramped versus sniffing position. |
We will intubate the patient in ramped versus sniffing position. |
| Comparator Agent |
Video laryngoscopy guided intubation. |
We will intubate the patient in ramped versus sniffing position with the help of video laryngoscope after which we will compare primary and secondary objectives. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Obese patients [BMI25- 30 kg/m² (according to WHO for Asian population) undergoing elective surgeries under General Anesthesia requiring endotracheal intubation.
Patients willing to participate and giving informed written consent.
Age more than 18 years.
ASA I & II. |
|
| ExclusionCriteria |
| Details |
Any patient with history of difficult intubation. Patient taking part in any other study.
Previous head and neck surgery or cervical spine defect.
The need for awake oral or nasal intubation.
Patient with acute respiratory infections.
Mallampatti Grade Class 4, Restricted mouth opening less than 2 fingers, Presence of any growth or tumor in oral cavity or pharynx. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the intubation time between ramped versus sniffing
2. To assess and compare IDS( Indubation Difficulty Scale) score between the two groups
|
Assessment will start at baseline from insertion of the video laryngoscope between teeth until successful intubation is confirmed by detecting end tidal carbondioxide. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare difficulty in mask ventilation using warters scale between the two groups.
2.To assess and compare the airway relayed complications in both groups. |
From inducing patient till successful tracheal intubation using videolaryngoscope |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 in obese patients presents unique challenges due to Anatomical and Physiological factors associated with obesity.
Various strategies including patient positioning and use of advanced laryngoscopy devices have been explored to enhance success rate in this population.
The traditional sniffing position has been widely used. However various studies suggest that ramped position where the patient upper body and head elevated to align the external auditory meatus with sternal notch may offer better visualisation of glottis and facilitate easier intubation.
Video laryngoscope has been shown to improve glottic view and increase success rate of intubation in obese patients when compare to traditional methods.
Unlike direct laryngoscopy video laryngoscopy does not require eye alignment with the three axis of intubation to visualize glottis.
However it remains unclear whether the use of Ramp position confers any benefit to video laryngoscopy guided intubation in obese patients.
There are fewer studies which have compared ramped position with sniffing position during video laryngoscopy guided intubation in obese patients.
Therefore this study is planned to compare the intubation characteristics in ramped vs sniffing position using video laryngoscopy in obese patients undergoing surgery in general Anesthesia. |