| CTRI Number |
CTRI/2023/05/052171 [Registered on: 01/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of pneumoperitoneum and head low position on respiratory parameters during robotic pelvic surgery |
|
Scientific Title of Study
|
To study the effect of pneumoperitoneum and trendelenberg position on respiratory mechanics during robotic pelvic surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PRIYA GUPTA |
| Designation |
DNB student |
| Affiliation |
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESHTHESIA
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE, FOUR BUNGLOWS , ANDHERI WEST
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8850393148 |
| Fax |
|
| Email |
pg170191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHARMILA RANADE |
| Designation |
DA DNB |
| Affiliation |
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESHTHESIA
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE, FOUR BUNGLOWS , ANDHERI WEST
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8850393148 |
| Fax |
|
| Email |
sharmilaranade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRIYA GUPTA |
| Designation |
DNB student |
| Affiliation |
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESHTHESIA
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE, FOUR BUNGLOWS , ANDHERI WEST
DEPARTMENT OF ANAESHTHESIA
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE, FOUR BUNGLOWS , ANDHERI WEST
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8850393148 |
| Fax |
|
| Email |
pg170191@gmail.com |
|
|
Source of Monetary or Material Support
|
| KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE.
ACHUTRAO PATWARDHAN MARG,
FOUR BUNGALOWS, ANDHERI WEST, MUMBAI, 400053. |
|
|
Primary Sponsor
|
| Name |
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESHTHESIA
KOKILABEN DHIRUBHAI AMBANI HOSPITAL MEDICAL AND RESEARCH INSTITUTE, FOUR BUNGLOWS , ANDHERI WEST |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KOKILABEN DHIRUBHAI AMBANI HOSPITAL AND MEDICAL RESEARCH INSTITUTE |
FOUR BUNGLOWS ANDHERI WEST400053 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PRIYA GUPTA |
KOKILABEN DHIRUBHAI AMBANI HOSPITAL AND MEDICAL RESEARCH INSTITUTE |
DEPARTMENT OF ANAESTHESIA, OPERATION THEATRE COMPLEX,5TH FLOOR.
Mumbai
MAHARASHTRA |
8850393148
pg170191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N428||Other specified disorders of prostate, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
|
|
| ExclusionCriteria |
| Details |
H/O SMOKING
BMI> 30 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study intraoperative changes of Peak Inspiratory pressure,plateau pressure and dynamic compliance of lungs due to pneumoperitoneum and trendelenberg position |
4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study hemodynamic effects of pneumoperitoneum and trendelenberg position
to study postoperative complications |
4 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
06/05/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PRIMARY OBJECTIVE - To study intraoperative changes of Peak inspiratory pressure, plateau pressure and dynamic compliance of lungs due to pneumoperitoneum and trendelenberg position SECONDARY OBJECTIVE- To study hemodynamic effects of pneumoperitoneum an trendelenberg position -To study postoperative complications |