| CTRI Number |
CTRI/2025/11/097707 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check which position is better between sniffing and ramp position during intubation done by second or third year resident in non obese patients |
|
Scientific Title of Study
|
A COMPARISON OF RAMP POSITION AND
SNIFFING POSITION DURING
ENDOTRACHEAL INTUBATION BY JUNIOR
RESIDENT (SECOND or THIRD YEAR) IN NON
OBESE ADULTS UNDER GENERAL
ANAESTHESIA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Gupta |
| Designation |
Resident doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Ananesthesia Department, General Ot Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, GUJARAT
Vadodara GUJARAT 391760 India |
| Phone |
8095946481 |
| Fax |
|
| Email |
aditig16295@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tejash Sharma |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Ananesthesia Department, General Ot Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, GUJARAT
Vadodara GUJARAT 391760 India |
| Phone |
9427332100 |
| Fax |
|
| Email |
drtejashs.sbks@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Tejash Sharma |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Ananesthesia Department, General Ot Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, GUJARAT
Vadodara GUJARAT 391760 India |
| Phone |
9427332100 |
| Fax |
|
| Email |
drtejashs.sbks@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Pipariya, Vadodara, Gujarat, India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodia, Pipariya, Vadodara, Gujarat, India Pincode- 391760 |
| Type of Sponsor |
Private 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 Tejash H Sharma |
Sumandeeep Vidyapeeth |
2nd floor OT complex, New Building, department of anaesthesia, Dhiraj Hospital, Shrimati Bhikiben Kanjibhai Shah Medical College and Research Centre, Sumandeep Vidyapeeth, Waghodia, Pipariya, Vadodara, Gujarat 391760, India Vadodara GUJARAT |
9427332100
drtejashs.sbks@sumandeepvidyapeethdu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical 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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Ramp position |
patient kept in ramp position during intubation (a pillow was kept under shoulders and head of the patient) |
| Comparator Agent |
Sniffing position |
Patient kept in sniffing position during intubation (a pillow of size 7 to 8 cms was kept under the head of the patient) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign written and informed consent.
Male or Female patients between 18 to 65 years of age.
Patients belonging to American Society of Anaesthesiologists physical status I and II.
Patients posted for elective surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in study.
Patients with Body Mass Index more than 30 Kg per metre square.
Patients with unstable cervical spine.
Patient with limited neck extension and flexion.
Patient with large neck masses.
Patients having arrythmias.
Patients having heart rate less than 60 beats per minute.
Psychiatric patients.
Pregnancy and lactating women.
Patients belonging to the American Society of Anaesthesiologists III and above. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the time for endotracheal tube insertion and
time of vocal cord visualisation. Number of intubation attempts made.
The laryngoscopic view will be graded according to the Cormack Lehane scale with and without cricoid
pressure.
Auxiliary methods used (change of laryngoscopist, bougie, change of device, stylet). |
To compare the time for endotracheal tube insertion and
time of vocal cord visualisation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe pain score during the postoperative phase in the post-intubation area. |
after extubation |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
29/11/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aditig16295@gmail.com].
- For how long will this data be available start date provided 10-11-2025 and end date provided 25-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Comparison of sniffing position and ramp position for endotracheal intubation in adults posted for elective surgery by second or third year resident under general anaesthesia. Objective is to compare the time for endotracheal tube insertion and time of vocal cord visualisation, the number of intubation attempts made, the laryngoscopic view will be graded according to the Cormack Lehane scale with and without cricoid pressure, any auxiliary methods used (change of laryngoscopist, bougie, change of device, stylet) and to observe pain score during the postoperative phase in the post-intubation area.
Inclusion criteria Patients willing to sign written and informed consent, male or female patients between 18 to 65 years of age, patients belonging to American Society of Anaesthesiologists(ASA) physical status I and II, patients posted for elective surgeries under general anaesthesia.
Exclusion criteria Patients unwilling to participate in study, patients with Body Mass Index more than 30 Kg per metre square, patients with unstable cervical spine, Patient with limited neck extension and flexion, Patient with large neck masses, Patients having arrythmias, Patients having heart rate less than 60 beats per minute, Psychiatric patients, Pregnancy and lactating women, Patients belonging to the American Society of Anaesthesiologists (ASA) III and above.
The study will be conducted on adults aged between 18-65 years of either gender, belonging to ASA grade I & II, who will undergo elective surgeries under general anaesthesia. Patients will be divided into 2 equal groups with computer generated block randomisation i.e. Group S will be in sniffing position during induction of anaesthesia. Group R will be in a Ramping position during induction of anaesthesia. After positioning laryngoscopy is performed and following things are to be observed and noted : Time of vocal cord visualisation (seconds), Time for endotracheal tube insertion (seconds), Number of intubation attempts made, Number of intubation attempts made, Cormack Lehane grade I or II a or II b or III or IV, Auxiliary method used (Bougie or Change of laryngoscopist either third year Resident or consultant or change of laryngoscope or Video laryngoscope or TAScope), Intubation done by Second year Resident or Third year Resident or Consultant. Postoperatively observe pain score in the post-intubation area.
Site of Study: Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and research Centre, Piparia, Waghodia, Vadodara.
Study Design: Prospective, comparative, observational.
Study Duration: The study will be initiated after obtaining permission from institutional ethics committee till the achievement of sample size or by 6 months whichever is earlier.
Statistics: Data will be collected & tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student-t test and/or ANNOVA will be used wherever appropriate for between-groups comparisons, while for categorical variables; chi-square test will be used. P value <0.05 will be considered statistically significant.
Likely outcome: This comparative study will help us to differentiate between sniffing and ramping position by junior resident (second/third year) in non-obese adults under general anaesthesia and will enable us to know which among the two positions for intubation is most beneficial in providing better stability to the patient. |