| CTRI Number |
CTRI/2024/04/065212 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
To compare the two types of mask holding technique for providing oxygen in obese patient for general anaesthesia before starting the surgery at SMS medical college Jaipur. |
|
Scientific Title of Study
|
A randomised study to compare the effectiveness of conventional thenar eminence versus modified thenar eminence mask ventilation technique in obese patient after induction of general anaesthesia at SMS medical college Jaipur. |
| 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 Sunita Meena |
| Designation |
Professor |
| Affiliation |
SMS Medical College and attached Hospitals,Jaipur |
| Address |
Department of Anaesthesiology,SMS Medical college and attached Hospitals, Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461290011 |
| Fax |
|
| Email |
sunitameena98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Meena |
| Designation |
Professor |
| Affiliation |
SMS Medical College and attached Hospitals,Jaipur |
| Address |
Department of Anaesthesiology,SMS Medical college and attached Hospitals, Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461290011 |
| Fax |
|
| Email |
sunitameena98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShivaraj M Ganiger |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and attached Hospitals,Jaipur |
| Address |
Department of Anaesthesiology,SMS Medical college and attached Hospitals, Adarsh Nagar,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8792563990 |
| Fax |
|
| Email |
sganiger96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,SMS Medical college and attached Hospitals, Jaipur. |
|
|
Primary Sponsor
|
| Name |
Sawai Mansingh Medical College and Hospital |
| Address |
Dept. of Anaesthesiology, Second Floor, Dhanvantri OPD Block, SMS Hospital 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 |
| DrShivaraj M Ganiger |
OT-2 SMS Medical College and attached Hospitals,Jaipur |
OT-2, II Floor, Dhanvantri Building, SMS Main Hospital Jaipur
Jaipur
RAJASTHAN |
8792563990
sganiger96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Offices 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 |
| Comparator Agent |
Comparsion of Two types of face mask ventilation in obese patient after induction of general anaesthesia. |
comparsion in terms of tidal volume delivered to the patient after starting of ventilation. |
| Intervention |
Group A- Face mask ventilation using conventional thenar eminence technique. |
After induction of general anaesthesia patient will be ventilated by this technique in which downward pressure is applied with thenar eminences of both hands and four fingers of each hand will be used to pull the jaw towards the mask. There will be increased chances of airway obstruction at oropharynx, in this technique as jaw is pulled upward towards the mask, leading to closure of mouth. It can be overcome by using appropriately sized oro-pharyngeal airway. |
| Intervention |
Group B- Face mask ventilation using modified thenar eminence technique. |
After induction of general anaesthesia patient will be ventilated by this technique in which downward pressure is
applied with thenar eminences of both hand and downward and upward force is given by the thumb at the chin to facilitate mouth opening apart from the jaw thrust. The chin left is avoided in this technique leading to adequate mouth opening and improving ventilation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to consent.
2.Patient posted for elective surgery.
3.Age between 18-60 years of either sex.
4.BMI 25-35kg/m2
5.ASA Class I,II,III |
|
| ExclusionCriteria |
| Details |
1.Patient part of other study group.
2.non-co-operative patient.
3.Anticipated difficult airway or difficult intubation.
4.Patients having maxilla-mandibular deformities.
5.Emergency surgeries.
6.Pregnancy
7.Patient with acute and chronic respiratory disorders
8.Presence of airway mass or tumor
9.patient requiring rapid sequence induction or awake intubation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.comparing the difference in mean expired tidal volume between both study group. |
for 12 breaths |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.difference in mean peak airway pressure between both study group.
2.difference in ETCO2 between both study group.
3.Ease of ventilation score between both study group.
4.VTE/AW,VTE/PBW ratio between both study group.
5.Proportion of cases requiring oropharyngeal airway due to failed mask ventilation in initial 3 breaths. |
for 12 breaths |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/04/2024 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Mask ventilation is
the most basic, yet the most essential skill in airway management. It is
primary technique of ventilation before tracheal intubation or insertion of any
airway devices. Maintainance of airway patency and oxygenation are the major
goals of mask ventilation in both elective and emergency conditions. It remains
an important bridge to a definitive airway in cases of difficult intubation. Obesity is
one of the predictor of Difficult mask ventilation. Obesity can be calculated
based on Body mass index. Body mass index is given by the formula BMI=Body
weight(kg)/Height(cm2).To achieve adequate
mask ventilation during anaesthesia we are using different techniques of mask
ventilation. There are multiple ways for hand positioning during mask
ventilation, one of them is one- handed technique and other one is two handed
technique. Two handed techniques are generally used in difficult mask
ventilation since they provide a better mask-to-face seal and greater tidal
volume. One such two handed thenar eminence technique are conventional and
modified. |