| CTRI Number |
CTRI/2022/06/042954 [Registered on: 01/06/2022] Trial Registered Prospectively |
| Last Modified On: |
27/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A observational study to compare laryngeal view in two different positions for intubation |
|
Scientific Title of Study
|
A comparative observational study of laryngeal views in two laryngoscopic positions- conventional 7cm head raise versus horizontal alignment of external auditory meatus and sternal notch line in patients undergoing elective surgeries under general anaesthesia requiring endotracheal intubation at SMS Medical College, Jaipur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
S.M.S Medical College |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Building, Sawai Mansingh Medical College and Attached Hospitals, Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchan Chauhan |
| Designation |
Professor |
| Affiliation |
S.M.S Medical College |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Building, Sawai Mansingh Medical College and Attached Hospitals, Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amirdath Prakash R |
| Designation |
Junior Resident |
| Affiliation |
S.M.S Medical College |
| Address |
Department of Anaesthesiology, Second Floor, Dhanwantari Building, Sawai Mansingh Medical College and Attached Hospitals, Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9444517870 |
| Fax |
|
| Email |
dramirdath92@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.M.S. Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Second Floor, Dhanwantari Building, Sawai Mansingh Medical College and Attached Hospitals, Adarsh Nagar,Jaipur |
| 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 Kanchan Chauhan |
SMS Medical College Hospital |
Operation theatre 2(OT2), 3rd floor, dhanwantari building, SMS hospital, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN |
8107872222
kanchan2371@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office Of The Ethics Committee, S.M.S Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K261||Acute duodenal ulcer with perforation, (2) ICD-10 Condition: N200||Calculus of kidney, (3) ICD-10 Condition: G930||Cerebral cysts, (4) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (5) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe, (6) ICD-10 Condition: M843||Stress fracture, (7) ICD-10 Condition: E052||Thyrotoxicosis with toxic multinodular goiter, (8) ICD-10 Condition: K710||Toxic liver disease with cholestasis, (9) ICD-10 Condition: K420||Umbilical hernia with obstruction,without gangrene, (10) ICD-10 Condition: N630||Unspecified lump in unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil since its an observational study |
| Intervention |
Nil |
Nil . Since its an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex scheduled to undergo elective surgical procedures requiring endotracheal intubation under general anaesthesia
2.Ages 18-65
3.Patients with ASA grade 1 and 2
4.MPG I to III |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patient with BMI > 30
3.Edentulous patients
4.Patients with cervical spine injuries
5.Patients with inability to open mouth (Mouth Opening < 3Fingers)
6.Patient with upper airway or neck pathologies
7.Pregnant patients
8.Patients requiring rapid sequence intubation |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportional Difference in Cormack Lehane grading in two laryngoscopy positions- sniffing position (SP) versus position attained by horizontal alignment of external auditory meatus- sternal notch line (AM-S) |
5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine difference in mean intubation time taken while performing laryngoscopy in SP position versus position attained by alignment of AM-S |
Within 5 minutes of testing position |
| Determine difference in Intubation Difficulty Scale (IDS) between two positions |
Within 5 minutes from achieving testing position |
| Determine mean pillow height required for alignment of AM-S position |
15 minutes after achieving AM-S position |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
02/06/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Plan to conduct the present study to compare the ease of intubation between the two different laryngoscopy positions and to find the optimal laryngoscopic plane to avoid difficult intuibating conditions. Intubation is an art that is practiced by all but perfected by anaesthetists and by doing this research we can avoid on table difficult airway scenarios which is a challenge to all anaesthetists. By finding out the optimal intubating position , the anaesthetist can pre operatively assess and place the patient in the optimal position and therby minimising the risk of difficult to ventilate and difficult to intubate situations. |