| CTRI Number |
CTRI/2021/10/037171 [Registered on: 07/10/2021] Trial Registered Prospectively |
| Last Modified On: |
29/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
An observational study of the occurence and reasons for difficult mask ventillation in adult surgical patients. |
|
Scientific Title of Study
|
An observational study of incidence and predictors of difficult mask ventilation in adult surgical patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anija A |
| Designation |
Junior Resident |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Department of Anesthesiology Vijayanagar Institute of Medical Sciences Vijayanagar Cantonment Ballari 583104
Department of Anesthesiology Vijayanagar Institute of Medical Sciences Vijayanagar Cantonment Ballari 583104
Bellary
KARNATAKA
583104
India |
| Phone |
8547325383 |
| Fax |
|
| Email |
anijaanilkumar2409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anija A |
| Designation |
Junior Resident |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Department of Anesthesiology Vijayanagar Institute of Medical Sciences Vijayanagar Cantonment Ballari 583104
Department of Anesthesiology Vijayanagar Institute of Medical Sciences Vijayanagar Cantonment Ballari 583104
Bellary
KARNATAKA
583104
India |
| Phone |
8547325383 |
| Fax |
|
| Email |
anijaanilkumar2409@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBDevanand |
| Designation |
Professor and HOD |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Department of Anesthesiology Vijayanagar Institute of Medical Sciences Vijayanagar Cantonment Ballari 583104
Department of Anesthesiology Vijayanagar Institute of Medical Sciences Vijayanagar Cantonment Ballari 583104
Bellary
KARNATAKA
583104
India |
| Phone |
9845233239 |
| Fax |
|
| Email |
dr.devanand.b@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Vijayanagar Institute of Medical Sciences Ballari |
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Sciences |
| Address |
Vijayanagar Cantonment
Ballari 583104 |
| 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 |
| Anija A |
Vijayanagar Institute of Medical Sciences |
Major OT complex,Vijayanagar Institute of Medical Sciences Vijayanagar Cantonment Ballari 583104
Bellary
KARNATAKA |
8547325382
anijaanilkumar2409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vijayanagar Institute of Medical Sciences Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 18-60 years of age,of either sex,posted for elective surgeries under general anesthesia
Patients allotted to ASA 1-3 |
|
| ExclusionCriteria |
| Details |
Refusal by patients for the procedure
Patient with obvious malformations of airway ( Trauma or burns or tumors or mass in neck or airway)
Patients requiring Rapid Sequence Intubation with cricoid pressure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The overall incidence of difficult mask ventilation |
After induction, before intubation,ie,9 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The different grades of mask ventilation
The various predictors of difficult mask ventilation and their correlation with the different grades of mask ventilation |
After induction, before intubation,ie,9 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/10/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in patients in the age group of 18-60 years of age,scheduled for elective surgeries under general anesthesia.The study will be conducted in the department of Anesthesiology,VIMS Ballari for the period of one year.Patients with obvious malformations of airway and patients requiring Rapid Sequence Intubation with cricoid pressure are excluded from the study.Data will be collected during the pre operative period.Clinical and ultrasound predictors of difficult mask ventilation will be noted.After taking informed and written consent, premedication will be given and evaluation of mask ventilation will be assessed by the one hand technique after induction of anesthesia.Signs of inadequate ventilation such as no perceptible chest movement,oxygen desaturation on pulse oximetry and perception of severe gas flow leak around the mask will be recorded and mask ventilation will be graded. |