| CTRI Number |
CTRI/2024/07/070316 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Choosing the best breathing method: How different ventilation modes affect breathing during laparoscopic surgeries in head down position |
|
Scientific Title of Study
|
Comparison between volume-controlled and pressure-controlled modes of ventilation on respiratory mechanics during laparoscopic surgeries requiring trendelenburg position |
| 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 Ratnala Swetha |
| Designation |
Junior Resident |
| Affiliation |
Department of Anesthesiology, Kasturba medical college and hospital, Manipal |
| Address |
NIH hostel,Eswar Nagar, Manipal,Udupi district, karnataka pin 576104, India
Udupi
KARNATAKA
576104
India |
| Phone |
8179100254 |
| Fax |
|
| Email |
palasaswetha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna HM |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical college |
| Address |
Department of Anesthesiology
Kasturba Medical college and hospital
Udupi
KARNATAKA
576104
India |
| Phone |
9845425862 |
| Fax |
|
| Email |
hm.krishna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna HM |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical college |
| Address |
Department of Anesthesiology
Kasturba Medical college and hospital
Udupi
KARNATAKA
576104
India |
| Phone |
9845425862 |
| Fax |
|
| Email |
hm.krishna@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Kasturba Medical College, Manipal, Udupi district, Karnataka, India
Pin code 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Anesthesiology, Kasturba Medical college and hospital, Manipal, Udupi district, Karnataka, India
Pin code 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ratnala Swetha |
Kasturba Medical College,Manipal |
Department of Anesthesiology, Kasturba Medical college, manipal
Udupi
KARNATAKA |
8179100254
palasaswetha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing laparoscopic surgeries requiring trendelenburg position under general anesthesia, American Society of Anesthesiologists classification I and II |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the tidal volume delivered with its corresponding peak pressure in volume controlled ventilation against the tidal volume delivered at the same set pressure in pressure controlled ventilation. Whether changing the mode of ventilation to PCV during laparoscopic surgeries will result in delivery of desired tidal volume at lower peak airway pressure |
T1:After intubation
T2: Immediately after creation of pneumoperitoneum in supine position
T3:After 10 minutes of creation of pneumoperitoneum with the patient in surgical position (30-degree head-low)
T4:20 minutes after creation of pneumoperitoneum in surgical position
T5: After desufflation in supine and neutral position |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare other respiratory parameters like compliance, mean airway pressures in both modes of ventilation |
Time point 1: After intubation
Time Point 2: Immediately after creation of pneumoperitoneum in supine position
Time point 3: After 10 minutes of creation of pneumoperitoneum with the patient in surgical position (30 degree head low position)
Time point 4: 20 mins after creation of pneumoperitoneum (30 degree head low position)
Time point 5: After desufflation in supine & neutral position |
|
|
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)
|
19/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Laparoscopic surgeries in trendelenburg position are known to have certain consequences on respiratory mechanics due to an increase in intra-abdominal pressure during creation of pneumoperitoneum and the subsequent trendelenburg position. One of the most frequently used modes of ventilation in general anaesthesia is Volume Controlled ventilation in which tidal volume is set which may result in high airway pressure. In Pressure controlled ventilation, the inspiratory pressure is set, and the tidal volumes could vary. The decelerating flow pattern in PCV could result in better tidal volume for a set inspiratory pressure, but the same has not been proven. |