| CTRI Number |
CTRI/2024/04/066459 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the ventilator mechanics during laparoscopic gynaecological surgeries |
|
Scientific Title of Study
|
Comparison of pressure controlled ventilation with volume controlled ventilation mode in patients undergoing laparoscopic gynaecologic surgery - A randomized control study |
| 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 Kathiravan K |
| Designation |
Post graduate in anaesthesiology |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of anaesthesiology,
Operation theatre complex - 105,
Sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8072345115 |
| Fax |
|
| Email |
kathirsiva994.tdk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasath C |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of anaesthesiology,
Operation theatre complex - 102,
Sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9787740890 |
| Fax |
|
| Email |
drpathin2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kathiravan K |
| Designation |
Post graduate in anaesthesiology |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of anaesthesiology,
Operation theatre complex - 104,
Sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8072345115 |
| Fax |
|
| Email |
kathirsiva994.tdk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Kathiravan K |
| Address |
Room no 45, Medical boys hostel , Sri manakula vinayagar medical college and hospital , Puducherry 605107 |
| 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 Kathiravan K |
Sri manakula vinayagar medical college and hospital |
OT Complex - 105
Department of anaesthesiology
Pondicherry
PONDICHERRY |
8072345115
kathirsiva994.tdk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To assess ventilator parameters in pressure controlled ventilation mode |
T1- 5 mins after induction
T2- 5 mins after lithotomy
T3- 5 mins after trendelenburg position
T4- 5 mins after pneumoperitoneum
T5- 5 mins before extubation |
| Comparator Agent |
To assess ventilator parameters in volume controlled ventilation mode |
T1- 5 mins after induction
T2- 5 mins after lithotomy
T3- 5 mins after trendelenburg position
T4- 5 mins after pneumoperitoneum
T5- 5 mins before extubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA PS 1 and ASA PS 2 patients
2.Patient posted for elective laparoscopic gynaecological surgery under general anaesthesia of duration more than 60 minutes |
|
| ExclusionCriteria |
| Details |
1.ASA PS 3
2.Smoker
3.Patient who are obese
4.Patient with difficult airway
5.Patient with chronic respiratory illness
6.Patient who are not fit for laparoscopic surgeries |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Respiratory mechanics - Mean airway pressure, peak airway pressure, plateau pressure, dynamic compliance , static compliance |
T1- 5 mins after induction
T2- 5 mins after lithotomy
T3- 5 mins after trendelenburg position
T4- 5 mins after pneumoperitoneum
T5- 5 mins before extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate, spo2, systolic blood pressure, diastolic blood pressure, MAP |
5 min
10 min
15 min
20 min
25 min
30 min
45 min
60 min
75 min
90 min
|
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
08/05/2024 |
| 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="6"
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
|
- This study is randomized single blinded parallel group study which compares the effects of volume controlled ventilation with pressure controlled ventilation in patients undergoing laparoscopic gynaecologic surgeries.
Laparoscopy has evolved
from a limited procedure to a versatile surgical tool for various gynecologic
and non-gynecologic indications. However, it can impact respiratory function
due to decreased functional residual capacity and increased airway pressure.
Modern respirators enable mechanical ventilation in various modes, including
pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV).
PCV offers faster tidal volume delivery and diffused gas distribution,
potentially resulting in lower peak airway pressure and reduced risk of
barotrauma. Despite these advantages, PCV is rarely used in laparoscopic
gynecologic surgery, and the choice between VCV and PCV is often based on
personal preference rather than clear guidelines. This study aims to compare
the effects of these ventilation modes on respiratory mechanics and hemodynamic
parameters in patients undergoing laparoscopic procedures and will be helpful
in determining the optimal mode of ventilation in patients undergoing
laparoscopic gynaecologic surgeries. |