| CTRI Number |
CTRI/2024/10/075201 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of laryngosopic view of glottis in elective surgery patient using sellicks & BURP maneuver in sniffing position with Macintosh & Hugemed Videolaryngoscopes under general anaesthesia. |
|
Scientific Title of Study
|
COMPARISON OF LARYNGOSOPIC VIEW OF GLOTTIS USING SELLICKS AND BURP MANEUVERS IN SNIFFING POSITION USING MACINTOSH AND HUGEMED VIDEO LARYNGOSCOPE |
| 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 Surinder Singh |
| Designation |
Head of department of anesthesia |
| Affiliation |
Indira gandhi medical college,Shimla |
| Address |
Department of anesthesia, Indira gandhi medical college, Shimla (h.p)
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418077565 |
| Fax |
|
| Email |
ss.igmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder Singh |
| Designation |
Head of department of anesthesia |
| Affiliation |
Indira gandhi medical college,Shimla |
| Address |
Department of anesthesia, Indira gandhi medical college, Shimla (h.p)
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418077565 |
| Fax |
|
| Email |
ss.igmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surinder Singh |
| Designation |
Head of department of anesthesia |
| Affiliation |
Indira gandhi medical college,Shimla |
| Address |
Department of anesthesia, Indira gandhi medical college, Shimla (h.p)
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418077565 |
| Fax |
|
| Email |
ss.igmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira gandhi medical college ,department of anesthesia, Shimla, Himachal pradesh
171001 |
|
|
Primary Sponsor
|
| Name |
Dr AKANKSHA SHARMA |
| Address |
Department of anesthesia, Indira gandhi medical college, Shimla |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ankita Chandel |
Indira gandhi medical college, department of anesthesia Shimla |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr AKANKSHA |
Indira gandhi medical college |
Department of anesthesia,Shimla,H.p
171001,
Sirmaur
HIMACHAL PRADESH |
9805109188
anku0534@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira gandhi medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laryngoscopic view without manuvers |
Comparison of laryngosopic view with out Sellicks and BURP maneuvers along with documentation of baseline Cl grade and POGO score. |
| Comparator Agent |
Laryngosopic view with maneuvers |
Comparison of laryngosopic view with Sellicks and BURP maneuvers along with documentation of Cl grade and POGO score. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
BMI less than 30
Mouth opening more than three |
|
| ExclusionCriteria |
| Details |
Unwilling patient
MPS three and four
TMD less then six
Pregnant patient
Patient with upper airway pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine safer intubation study in elective surgical procedures |
Baseline,1mint,5mint,10mint |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of safety & tolerability of intervention |
24hours postoperative |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
24/10/2024 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
We are comparing percentage of glottic opening and Cormack lehane grading using various video/macintosh laryngoscope in pt having elective surgical procedures in general anaesthesia. Outcome of this study shall aid in determining safer intubation practice in elective surgical procedures . |