| CTRI Number |
CTRI/2023/09/057473 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison between three modes of mask ventilation under general anaesthesia for laparoscopic surgeries |
|
Scientific Title of Study
|
Comparison between three modes of mask ventilation in Laparoscopic surgeries under 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 |
Divya Priya Mani |
| Designation |
Junior resident |
| Affiliation |
KS Hegde medical Academy |
| Address |
Department of Anaesthesiology
K S Hegde Medical Academy
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9901484411 |
| Fax |
|
| Email |
divyapriya065@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siri Kandavar |
| Designation |
Associate Professor |
| Affiliation |
KS Hegde medical Academy |
| Address |
Department of Anaesthesiology
K S Hegde Medical Academy
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9739868002 |
| Fax |
|
| Email |
sirikandavar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Priya Mani |
| Designation |
Junior resident |
| Affiliation |
KS Hegde medical Academy |
| Address |
Department of Anaesthesiology
K S Hegde Medical Academy
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9901484411 |
| Fax |
|
| Email |
divyapriya065@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.S. Hegde medical academy hospital
Nithyananda nagar
Mangaluru-575018 |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy hospital |
| Address |
Department of Anaesthesiology
K S Hegde Medical Academy
Deralakatte
Mangalore |
| Type of Sponsor |
Private 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 Divya Priya Mani |
K.S. Hegde medical academy |
Department of Anaesthesiology
K S Hegde Medical Academy
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA |
9901484411
divyapriya065@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , K S Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K829||Disease of gallbladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Different modes of mask ventilation |
pressure control mode |
| Comparator Agent |
mask ventilation |
manual ventilation mode - 3minutes |
| Comparator Agent |
masking ventilation |
volume control mode |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2
Posted for laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
patient refusal, diabetes mellitus , pregnancy , BMI >30, anticipated difficult mask ventilation and intubation, risk of upper airway obstruction, including large tonsils and history of obstructive sleep apnea, conditions with risk of aspiration. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gastric insufflation is least with pressure control mode |
3 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
inspiratory tidal volume in PCV & MCV mode
peak inspiratory pressure in MCV and VCV mode
expiratory volume in MCV,VCV and PCV mode |
3 minutes |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/09/2023 |
| 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="3"
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 required to sustain arterial oxygenation and alveolar ventilation. Adequate and effective mask ventilation is required to prevent high intra abdominal pressure thereby preventing aspiration. This study involves in finding the best method that causes least gastric insufflation during mask ventilation after induction of anaesthesia. Three types of mask ventilation are being compared which include manual controlled ventilation, volume controlled ventilation and pressure controlled ventilation. |