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
|
|
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
|
|
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 POSITIONâ€. 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. |