| CTRI Number |
CTRI/2024/06/068350 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
New mask ventilation technique in obese patients for general anaesthesia |
|
Scientific Title of Study
|
Efficacy of novel EP technique of mask ventilation versus standard CE technique in obese patients for general anaesthesia |
| 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 Murshida U C |
| Designation |
Junior resident doctor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital and medical college |
| Address |
4th floor,Department of Anaesthesiology,College building,Lokmanya Tilak Municipal Medical COollege,Sion,Mumbai 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9096978277 |
| Fax |
|
| Email |
murshidauc121@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Urvi H Desai |
| Designation |
Associate Professor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital and medical college |
| Address |
4th floor,Department of Anaesthesiology,college building,Lokmanya Tilak municipal medical college,Sion,Mumbai 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9821598190 |
| Fax |
|
| Email |
urvi_desai@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Murshida U C |
| Designation |
Junior resident doctor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital and medical college |
| Address |
4th floor,Department of Anaesthesiology,college building,Lokmanya Tilak Municipal medical college,Sion,Mumbai 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9096978277 |
| Fax |
|
| Email |
murshidauc121@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal General Hospital and Medical College,Sion,Mumbai 400022 |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal General Hospital and Medical CollegeSionMumbai |
| Address |
Lokmanya Tilak Municipal General Hospital and Medical College,Sion west,Mumbai 400022 |
| 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 Murshida U C |
Lokmanya Tilak Municipal General Hospital and Medical College |
4th floor,Department of Anaesthesiology,college building,Lokmanya Tilak Municipal General Hospital and Medical College,Sion west,Mumbai 400022 Mumbai MAHARASHTRA |
9096978277
murshidauc121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research,Lokmanya Tilak Municipal Medical College and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of more than 18 years whose BMI is more than 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Emergency surgery requiring RSI
2.Pregnant women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the effectiveness of EP
technique in obese adult population of mask ventilation in elective
and emergency surgeries as compared to standard CE technique
by evaluating the following parameters
1.Chest expansion(yes/no)
2.Capnography in numbers(35-40)
3.Inhaled and Exhaled Tidal Volume in ml
4.Peak airway pressure in mmhg |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the failure rate of mask Ventilation for general anaesthesia by CE & EP technique |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
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)
|
21/06/2024 |
| 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="0" 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 primary technique of ventilation before intubation or insertion of any airway devices during general anaesthesia.It is also a rescue technique for ventilation during unsuccessful attempts at intubation and difficult airway situations. There can be several factors contributing to inadequate mask ventilation that can be classified as patient related (such as beard, edentulous, thick neck),equipment related (inappropriate size mask ,non cushioned rim of the masks) or operator related factors (inexperience ,improper technique). Airway management is more challenging in obese patients. They have impaired respiratory mechanics, decreased FRC and vital capacity ,increased airway resistance and reduced oxygen reserve. Maintaining airway patency may be difficult in obese patients due to high collapsibility of upper airway structures and technical difficulty in applying the mask. Sustained effective mask ventilation becomes difficult in obese patient due to strain because of the heavy jaw and large neck circumference causing fatigue to the operator. In order to tackle these difficulties we are studying an alternative novel technique which is a variant of VE technique named as EP technique. This technique provides a better seal and is an easy and strain free method than the standard CE technique that we use in mask ventilation .The CE technique applies the mask by forming a C shape with each thumb and index finger over each side of the mask while the third ,fourth and fifth fingers of both hands lift the mandible towards the mask in a three fingered E shape .In contrast, the EP technique uses each thumb over the mask which pushes the mask down to provide a better seal, while the second to fourth digits are along the mandible like an E that pull it upwards and the little finger behind the pinna for a better grip ,support and stability .This will not only improve the quality of ventilation ,ie, oxygenation and outcomes but also makes the operator fatigue free |