| CTRI Number |
CTRI/2024/04/065544 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to compare the laryngoscopic vision of vocal cords in two positions, ramp position and conventional sniffing position during endotracheal intubation. |
|
Scientific Title of Study
|
A prospective comparative study of laryngoscopic vision of vocal cords in ramp position and conventional sniffing position during endotracheal intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VAISHNAVI S S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS HOSPITAL, MYSORE, KARNATAKA.
Mysore KARNATAKA 570004 India |
| Phone |
8111829328 |
| Fax |
|
| Email |
ssvaishnavi95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr VYSHNAVI S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, JSS HOSPITAL, MYSORE, KARNATAKA.
Mysore KARNATAKA 570004 India |
| Phone |
9880110022 |
| Fax |
|
| Email |
vyshgiri@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr VYSHNAVI S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, JSS HOSPITAL, MYSORE, KARNATAKA.
Mysore KARNATAKA 570004 India |
| Phone |
9880110022 |
| Fax |
|
| Email |
vyshgiri@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
JSS MEDICAL COLLEGE AND HOSPITAL, MYSORE |
| 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 |
| VAISHNAVI S S |
JSS MEDICAL COLLEGE AND HOSPITAL |
Patients of ENT,ORTHOPEDICS, NEUROSURGERY,GENERAL SURGERY, GASTROSURGERY, posted for elective surgery under general anesthesia, OT complex, JSS HOSPITAL, MG road, AGRAHARA. Mysore KARNATAKA |
8111829328
ssvaishnavi95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Medical College, JSS Academy of Higher Education and Research, 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 |
| Comparator Agent |
Laryngoscopy in ramp position |
Modified Cormack Lehane grading will be noted during laryngoscopy during ramp position |
| Intervention |
Laryngoscopy in sniffing position |
Modified Cormack Lehane grading will be noted during laryngoscopy in sniffing position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years.
Either sex.
ASA status 1 and 2.
Patients undergoing surgery under general anesthesia which require oral intubation. |
|
| ExclusionCriteria |
| Details |
ASA status 3 and above.
Patients with unstable cervical spine and spine abnormalities.
Patients who require rapid sequence intubation aor awake intubations.
Gross facial abnormalities.
Orofacial injuries.
Nasal intubations. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the larngoscopic vision of vocal cord in ramp position and conventional sniffing position during endotracheal intubation by assessing Modified Cormack Lehane scale. |
Starting from patient positioning for endotracheal intubation till 5 minutes after completion of endotracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the ease of intubation by need for use of external laryngeal maneuvre & airway adjunct devices
To assess the association between Modified Cormack Lehane grading, Mallampatti score & neck circumference in deciding the difficulty in intubation. |
Starting from patient positioning for intubation till 5 minutes after completion of endotracheal intubation. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
15/04/2024 |
| 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="1" Months="2" 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 informed consent from the patients, those patients
included in ASA physical class I-II in the age group of 18-60 years of either
sex undergoing elective surgery under general anesthesia requiring endotracheal
intubation is selected for the study.
Pre anaesthetic evaluation of the patient
posted for surgery will be conducted on the day before surgery and
pre-anesthetic orders will be given. The patient’s BMI, Mallampati Score,
Thyromental distance and Neck circumference will be noted. The patients will be
divided into two groups, Group S and Group R.
On the day of the surgery, inside the
operation theatre, monitoring of Oxygen saturation, heart rate, non invasive
blood pressure will be done. A patent IV cannula will be provided and IV fluids
will be started for fluid management. Patient will be preoxygenated with 100%
oxygen for 3 minutes, premedicated with Inj MIDAZOLAM 0.01mg/kg, Inj
GLYCOPYRROLLATE 0.01 mg/kg and Inj FENTANYL 2mg/kg. Patient will be induced
with Inj PROPOFOL 2mg/kg and muscle relaxant Inj VECURONIUM 0.1mg/kg will be
given. For the first group (Group S), laryngoscopy will be done in “sniffing
position†first and Cormack Lehane grade will be noted, after which table
position will be changed to get a “ramp position†measuring 500+/-60
angle using protractor, the end point being the external auditory meatus and sternal notch
are in horizontal line. This will be confirmed by using the Scale Ampoule
Method where a transparent ampoule will be plastered to a long metallic scale and
held between EAM and sternal notch. The table elevation and head end
flattening, after the initial lift to 50 degree will be adjusted such that the
bubble in the ampoule comes to lie in the centre. Modified Cormack lehane grading will be noted in this
position again. For the next group (GroupR) , laryngoscopy will be done in RAMP
position first and in sniffing position later. The endotracheal tube of
appropriate size will be inserted and during the process the ease with which
tube is passed will be assessed, by assessing the need for any external
manuevres or use of adjunct devices like style or bougie. The position of the
ET tube will be confirmed with 5 point auscultation and capnography.
In case the intubation is difficult in
either of the positions, a switch will be made to the other position. If intubation
is still difficult after change in position, call for help and difficult irway
algorithm will be initiated assuming an
unanticipated difficult airway scenario. |