| CTRI Number |
CTRI/2020/06/026158 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
25/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare two techniques of mask ventilation |
|
Scientific Title of Study
|
Comparison of the Effectiveness of Two-handed Mask Ventilation Techniques (C-E Versus V-E) in Obese patients requiring General Anaesthesia: A Randomised,
Interventional Study at SMS Medical College, Jaipur during 2019-2021 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
SMS MEDICAL COLLEGE |
| Address |
Dept of Anaesthesiology, 2nd floor, Dhanvanthri complex,SMS Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
SMS MEDICAL COLLEGE |
| Address |
Dept of Anaesthesiology, 2nd floor, Dhanvanthri complex,SMS Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghana S Bharadwaj |
| Designation |
Junior resident |
| Affiliation |
SMS MEDICAL COLLEGE |
| Address |
412, SMS PG GIRLS HOSTEL,
behind Charak Bhavan,gate no 6, JLN Marg,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8073059832 |
| Fax |
|
| Email |
meghanasb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
SMS Hospital |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIOLOGY |
| Address |
SMS Hospital
Department of Anaesthesia, 2nd floor,dhanvanthri opd complex,Sawai man singh road, Jaipur,Rajasthan 302004 |
| 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 Mamta Sharma |
SMS HOSPITAL |
OT-2(General surgery OT), 2nd floor, Department of Anaesthesia
Jaipur
RAJASTHAN |
9829566077
drmamtasharma@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committee, SMS Medical College and Attached Hospitals,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mask ventilation V-E technique |
36 obese subjects undergo ventilation by V-E technique after induction for the first ten breaths effectively delivered by the ventilator |
| Intervention |
Mask ventilation-C-E technique |
36 obese subjects undergo ventilation by C-E technique after induction for the first ten breaths effectively delivered by the ventilator |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI> 25- 35 kg/M-2
2. Undergoing elective surgery under GA
3. ASA I,II,III
|
|
| ExclusionCriteria |
| Details |
1.Acute and chronic respiratory disorders including COPD and asthma
2.Emergency surgery
3.Induction requiring rapid sequence for intubation
4.Pregnant women
5.Patients requiring awake intubation
6.Presence of beard, temporo-mandibular jaw abnormalities, adentulous patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in mean expired tidal volume (VTe) between the two mask ventilation techniques(C-E Vs V-E) after induction of general anaesthesia |
The parameters will be recorded for first ten breaths delivered by the ventilator for the first ten minutes after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)To compare the difference in peak airway pressure between the two groups
b)To compare VTe/actual weight, VTe/predicted body weight between the two groups
c)To determine the difference in percentage of cases requiring oropharyngeal airway due to failure of ventilation between the two groups
d)To determine the failure rates of mask ventilation
|
The parameters will be recorded for the first ten breaths delivered by the ventilator for the first ten minutes after induction |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
30/06/2020 |
| 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="5"
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)?
|
|
Brief Summary
|
In this study we aim to compare the effectiveness of two
mask ventilation techniques in obese patients, Mask ventilation being an
important step in anaesthesia, it is imperative to determine the outcome.
|