| CTRI Number |
CTRI/2024/02/062316 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Prediction of Difficult airway using a Obesity Score . |
|
Scientific Title of Study
|
Evaluation of STOP-BANG SCORE as a screening tool to predict the difficult airway . |
| 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 Kiranpreet Kaur |
| Designation |
Professor |
| Affiliation |
Pt. B.D.Sharma PGIMS , Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D.Sharma,PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992249436 |
| Fax |
|
| Email |
kiranpreet72@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paramjeet |
| Designation |
Junior Resident |
| Affiliation |
Pt. B.D.Sharma PGIMS , Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D.Sharma,PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7988384197 |
| Fax |
|
| Email |
paramjeetps1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paramjeet |
| Designation |
Junior Resident |
| Affiliation |
Pt. B.D.Sharma PGIMS , Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B.D.Sharma,PGIMS,Rohtak
HARYANA
124001
India |
| Phone |
7988384197 |
| Fax |
|
| Email |
paramjeetps1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.B.D.Sharma university of Health Sciences PGIMS , Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma University of Health Sciences PGIMS,Rohtak |
| Address |
Pt.B.D.Sharma University of Health Sciences PGIMS,Rohtak |
| 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 Paramjeet |
Pt.B.D.Sharma PGIMS Rohtak |
Department of Anaesthesiology and Critical Care , PGIMS, Rohtak
Rohtak
HARYANA |
7988384197
paramjeetps1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethic committee pt. BD Sharma PGIMS/UHS Rohtak |
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
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Two hundred and forty patients of either sex aged 25-65 years
belonging to American Society of Anaesthesiologists (ASA) physical status I, II and III
scheduled for elective surgery under general anaesthesia requiring endotracheal
intubation will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients having respiratory or pharyngeal pathology, mouth opening <2.5cms, pregnancy, full stomach, unconscious state, anticipated difficult airway and any patient who refuses to participate in the study will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Is to find an association between STOP-Bang score and difficult mask ventilation,difficult laryngoscopy and intubation |
Before induction see,
Presence of snoring
Tiredness
Observed breathing cessation while sleeping
Blood pressure
BMI
Age
Neck circumference
Gender |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
is to find
• Mask ventilation grade
• Cormack- Lehane Grade
• Intubation difficulty score
• Post-operative complications |
STOP-BANG SCORE
Mask ventilation Grading
Difficulty of Laryngeal Blade Insertion
Cormack-Lehane Grading
Intubation Difficulty Score
Post Operative Compliactions |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
25/02/2024 |
| 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="1"
Months="1"
Days="0" |
|
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
|
This is an observational study being done to predict the relation between the STOP-BANG Score and Difficult intubation .The various Parameters included in STOP-BANG score are snoring, tiredness, observed breathing cessation while sleeping ,Blood Pressure,Body Mass Index, age, neck circumference, and gender. After enrollment , Study subjects will be randomly allocated in two subgroups depending on the STOP-BANG score . Mask ventilation Grading , diffilculty of laryngeal blade insertion, CL grading , Intubation difficulty score , Post operative complications are also included in this study .
|