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CTRI Number  CTRI/2024/02/062195 [Registered on: 01/02/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   It is a Comparative study of sniffing position versus RAMP position for teaching and learning endotracheal intubation in new Anaesthesiology residents 
Scientific Title of Study   Comparative study of sniffing versus ramp position for teaching and learning endotracheal intubation in novice Anaesthesiology residents 
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 Hemlata Kamat 
Designation  Professor, Department Of Anaesthesiology 
Affiliation  Pramukh Swami Medical College, Karamsad. 
Address  Shree Krishna Hospital, Gokalnagar, Karamsad. Dist Anand

Anand
GUJARAT
388325
India 
Phone  9909929422  
Fax    
Email  hemlatavk@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Patel Hemaliben Kishorbhai 
Designation  PG RESIDENT 
Affiliation  PRAMUKH SWAMI MEDICAL COLLEGE, KARAMSAD 
Address  ROOM NO. 32 PG HOSTEL, THE HEALING TREE GATE, SHREE KRISHNA HOSPITAL, KARAMSAD DIST. ANAND
3 SANNIDHYA SHREE HARI LAXMI NARAYAN CO OP SOCIETY AANAND CINEMAX ROAD GAUHARBAUG BILIMORA
Anand
GUJARAT
388325
India 
Phone  9727465415  
Fax    
Email  hemali1511@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Patel Hemaliben Kishorbhai 
Designation  PG RESIDENT 
Affiliation  PRAMUKH SWAMI MEDICAL COLLEGE, KARAMSAD 
Address  ROOM NO. 32 PG HOSTEL, THE HEALING TREE GATE, SHREE KRISHNA HOSPITAL, KARAMSAD DIST. ANAND
3 SANNIDHYA SHREE HARI LAXMI NARAYAN CO OP SOCIETY AANAND CINEMAX ROAD GAUHARBAUG BILIMORA

GUJARAT
388325
India 
Phone  9727465415  
Fax    
Email  hemali1511@gmail.com  
 
Source of Monetary or Material Support  
Shree Krishna Hospital, Karamsad. 
 
Primary Sponsor  
Name  Shree Krishna Hospital Karamsad 
Address  Shree Krishna Hospital, Gokalnagar, Karamsad. Dist Anand 388325 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemali Patel  Shree Krishna Hospital, KARAMSAD  Department of Anaesthesiology, Shree Krishna Hospital, Gokalnagar, Karamsad,,DIST ANAND 388325
Anand
GUJARAT 
9727465415

hemali1511@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified, (2) ICD-10 Condition: 2||Placement, (3) ICD-10 Condition: 2||Placement, (4) ICD-10 Condition: 2||Placement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  A) age- 18 to 70 years
B)ASA Grade 1 to 3
C) Mallampatti grade 1 to 3
D) Elective surgeries.
E) use of portex cuffed endotracheal tube only
F) use of routine induction agents only.
 
 
ExclusionCriteria 
Details  A)Head and neck surgeries
B)BMI >35, morbid obese patient
C)Limited Neck extension on preoperative airway examination
D)Protruding incisora
E)Macro/micrognathia
F)Obstetric patients
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Laryngeal exposure –Achievement of Cormack Lehane grade I/II   30 SECONDS  
 
Secondary Outcome  
Outcome  TimePoints 
success at first attempt intubation.  60 seconds 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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 2 
Date of First Enrollment (India)   15/02/2024 
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="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 - NO
Brief Summary  

-  After obtaining ethics committee approval and written and informed consent, patients undergoing elective surgery under general anaesthesia (except obstetric patients) will be recruited for the study.

-   Participants (novice residents) will be classified into two random groups by ask them to pick a chit randomly. There will be two chits, one naming GROUP -S “SNIFF POSITION” and other naming GROUP -R “RAMP POSITION”.  Once the residents are allotted a particular group, he/she will continue to perform intubation in allotted position only.

-  The position for intubation will be given according to the group to which the resident belongs.

-  Pre anaesthetic check-up would be carried out for all the participants day prior to surgery.

-  On arrival to operating room, routine monitoring, that includes pulse oximetry, electrocardiography, non-invasive blood pressure measurement and manual blood pressure will be attached and base line parameters will be noted.

-  The position will be given according to the allotted category.

-  The sniffing position will be given by using gel head-ring under occiput.

-  The ramp position will be given by using gel bolster under the shoulder of the patient to get external auditory meatus and sternal notch in linear alignment and confirmed by using spirit level ruler.

-  All the participants will be pre medicated with inj glycopyrolate 0.005-0.01 mg/kg, inj. Midazolam 0.1-0.2 mg/kg iv, inj fentanyl 1-2 mcg/kg iv, inj lignocaine (2%, preservative free) 3cc iv

-  Pre oxygenation will be done with 100% oxygen for 3 minutes delivered via close circuit. The induction of anaesthesia will be done with propofol (2-2.5 mg/kg) and muscle relaxation achieved with inj succinylcholine (1- 1.5 mg/kg).

-  After achieving adequate muscle relaxation, laryngoscopy will be performed with Macintosh laryngoscope blade no 3 for female and blade no 4 male. Novice resident will be asked about the glottic view that has been obtained by him/her at first attempt by showing them the Cormack-Lehane Classification chart. They will be asked to indicate the Cormack-Lehane grade 1 or 2 on the charts of the diagram shown to them. If inability to achieve grade1 or 2 , external laryngeal manuver will be apllied and again glottic view will be reviewed ,endotracheal tube will only be inserted  after acheiving grade 1 or 2 otherwise senior will take over . Total time will be given of 30 seconds to the novice resident for placement of the endotracheal tube. after that, the senior resident will take over the procedure.

-  The time duration will be noted from insertion of the laryngoscope into the oral cavity till attainment of 5-7 successive square wave formation on capnograpghy.

 
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