| CTRI Number |
CTRI/2023/01/049046 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
2 modes of ventilation ie pressure controlled ventilation and volume controlled ventilation will be compared on patients undergoing gynaecological laparoscopic surgeries using I-gel ( a novel supraglottic airway device) |
|
Scientific Title of Study
|
A Prospective randomised study comparing pressure controlled ventilation and volume controlled ventilation using I-gel during gynaecological laparoscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Bhattacharyya |
| Designation |
Post graduate student( MD) |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Calcutta National Medical College and Hospital
Department of Anesthesiology
Emergency building,4th floor
Kolkata
WEST BENGAL
Kolkata 700014
India |
| Phone |
|
| Fax |
|
| Email |
ankbh1411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mausumi Niyogi |
| Designation |
Professor and Head of Department ( Department of Anaesthesiology) |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Calcutta National Medical College and Hospital
Department of Anesthesiology
Emergency building, 4th floor
Department of Anesthesiology
Kolkata
WEST BENGAL
Kolkata 700014
India |
| Phone |
|
| Fax |
|
| Email |
dr.mausumimitra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Bhattacharyya |
| Designation |
Post graduate student( MD) |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Calcutta National Medical College and Hospital
Department of Anesthesiology
Emergency building, 4th floor
Kolkata
WEST BENGAL
Kolkata 700014
India |
| Phone |
|
| Fax |
|
| Email |
ankbh1411@gmail.com |
|
|
Source of Monetary or Material Support
|
| Calcutta National Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Calcutta National Medical College and Hospital |
| Address |
32, Gorachand Road, Beniapukur, Kolkata, West Bengal 700014 |
| 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 Ankita Bhattacharyya |
Calcutta National Medical College and Hospital |
Gynaecology OT, 1st floor,
Gynaecology and obstetrics building
32, Gorachand Road, Beniapukur,Kolkata, West Bengal 700014
Kolkata
WEST BENGAL |
8910044232
ankbh1411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Calcutta National Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N839||Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pressure controlled ventilation |
The patient will be maintained in pressure controlled mode of ventilation after I-gel insertion in gynaecological laparoscopic surgeries of duration less than 90 minutes |
| Comparator Agent |
Volume controlled ventilation |
The patient will be maintained in volume controlled mode of ventilation after I-gel insertion in gynaecological laparoscopic surgeries of duration less than 90 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 and 2
Patient undergoing elective short duration ( less than 90 minutes) gynaecological laparoscopic surgeries |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)BMI> 30 kg/m2
3)ASA grades 3,4,5 and emergency
4) Patients with difficulty in mouth opening
5) Upper airway abnormalities
6)Macroglossia
7) Pregnancy and breast feeding mothers
8) Recent head and neck surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peak inspiratory pressure |
Just after insertion of I-gel, 5 minutes and 15 minutes after pneumonia-peritoneum, thereafter 15 minutes till extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lung mechanics
Hemodynamic response |
Just after insertion of I-gel and at 5 minutes and 15 minutes after pneumonia-peritoneum |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/01/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
80 female patients ( ASA 1 and 2), candidates for elective gynaecological surgeries of duration less than 90 minutes will be enrolled for this prospective randomised study after taking written consent from the patients.The participants will be randomly assigned to receive pressure controlled ventilation (PCV) or volume controlled ventilation (VCV) after insertion of I-gel by standard technique. In VCV group, ventilation will be done with tidal volume of 10ml/kg ideal body weight (IBW)and in PCV group, baseline ventilation will be done with a peak inspiratory pressure that provides a tidal volume of 10ml/kg IBW. Peak inspiratory pressure and other lung mechanics and hemodynamic response will be compared at 5 minutes after I-gel insertion, 5 and 15 minutes after pneumonia-peritoneum and thereafter 15 minutes till extubation. |