| CTRI Number |
CTRI/2025/02/080597 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study aims to find out which of two ventilation methods (volume-controlled or pressure-controlled) is better for patients undergoing robotic surgery for lower abdominal cancer, while they are positioned in a slight head-down tilt (Trendelenburg position). |
|
Scientific Title of Study
|
Effect of volume and pressure controlled ventilation on arterial to end-tidal carbondioxide gradient P(a-ET)CO2 in patients undergoing robotic lower abdominal oncological surgery in the trendelenburg position :a randomised prospective comparative 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 |
Nishanthi M |
| Designation |
Post graduate |
| Affiliation |
Kidwai memorial Institute of oncology |
| Address |
Operation theatre complex 105,Department of Anesthesia and pain relief, Kidwai memorial Institute of oncology, Hombegowda nagar,Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
09942541380 |
| Fax |
|
| Email |
nishamadhesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARATHI BH |
| Designation |
Professor and HOD |
| Affiliation |
Kidwai memorial Institute of oncology |
| Address |
Operation theatre complex 105,Department of Anesthesia and pain relief, Kidwai memorial Institute of oncology, Hombegowda nagar,Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9845285207 |
| Fax |
|
| Email |
arathibh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ROOPA BO |
| Designation |
Assistant professor |
| Affiliation |
Kidwai memorial Institute of oncology |
| Address |
Operation theatre complex 105,Department of Anesthesia and pain relief, Kidwai memorial Institute of oncology, Hombegowda nagar
Bangalore
KARNATAKA
560029
India |
| Phone |
9538860297 |
| Fax |
|
| Email |
dr.roopa.onkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Operation theatre complex 105,Department of Anesthesia and pain relief, Kidwai memorial Institute of oncology, Hombegowda nagar,Bangalore,Karnataka(State)- 560029,
India |
|
|
Primary Sponsor
|
| Name |
DR NISHANTHI M |
| Address |
Room num 8, Post graduate women hostel , kidwai memorial Institute of oncology,dr.M.H.Marigowda road, Bangalore,Karnataka -560059 |
| 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 NISHANTHI M |
Kidwai memorial Institute of oncology |
Operation theatre complex 105,Department of Anesthesia and pain relief, Kidwai memorial Institute of oncology, Hombegowda nagar 560029
Bangalore
KARNATAKA |
9942541380
nishamadhesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C762||Malignant neoplasm of abdomen, (2) ICD-10 Condition: C763||Malignant neoplasm of pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pressure controlled ventilation |
Effect of pressure controlled ventilation on arterial to end tidal carbondioxide gradient |
| Comparator Agent |
Volume controlled ventilation |
Effect of volume controlled ventilation on arterial to end tidal carbondioxide gradient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade I & II
2.Patients with BMI between 18.5 AND 30kg/m2
3.Patients undergoing elective Robotic lower abdominal and pelvic surgery in the trendelenberg position |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.BMI more than35
3.Chronic smokers
4.Documented chronic obstructive pulmonary disease.
5.Increased Pulmonary artery pressure in Echocardiography
6.Poor cardiac reserve
7.Asthma or other chronic lung diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effects of two different ventilatory modes, PCV and VCV on Arterial to end tidal carbondioxide gradient P(a-ET) CO2 in patients undergoing elective robotic lower abdominal and pelvic oncological surgery |
10HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of VCV & PCV in Peak airway pressure (Paw),Dynamic compliance (Cdyn),Alveolar to arterial oxygen gradient (P(A-a)O2),Hemodynamics & to measure Alveolar dead space fraction (AVDSF) by modified Bohrs equation in elective robotic lower abdominal & pelvic oncological surgery |
10 HOURS |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
15/02/2025 |
| 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 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 IS RANDOMISED PROSPECTIVE COMPARATIVE STUDY COMPARING THE EFFECTS OF VOLUME CONTROLLED VENTILATION (VCV) AND PRESSURE CONTROLLED VENTILATION (PCV) ON ARTERIAL TO END TIDAL CARBONDIOXIDE GRADIENT IN PATIENTS UNDERGOING ROBOTIC LOWER ABDOMINAL ONCOLOGICAL SURGERY IN THE TRENDELENBERG POSITION . PATIENTS WILL BE RANDOMISED INTO EITHER GROUP PCV OR GROUP VCV AND FROM THE ARTERIAL BLOOD SAMPLE ARTERIAL BLOOD GAS ANALYSIS WILL BE DONE AND BASELINE VALUES WILL BE NOTED. PRIMARY OBJECTIVE IS TO ASSESS THE EFFECTS OF TWO DIFFERENT VENTILATORY MODES , PCV AND VCV ON ARTERIAL TO END TIDAL CARBONDIOXIDE GRADIENT IN THESE PATIENTS. SECONDARY OBJECTIVE IS TO COMPARE THE EFFECTS OF VCV AND PCV IN PEAK AIRWAY PRESSURE (Paw),DYNAMIC COMPLIANCE (Cdyn),ALVEOLAR TO ARTERIAL OXYGEN GRADIENT (P(A-a)O2),HEMODYNAMICS AND TO MEASURE ALVEOLAR DEAD SPACE FRACTION (AVDSF) BY MODIFIED BOHRS EQUATION IN ELECTIVE ROBOTIC LOWER ABDOMINAL AND PELVIC ONCOLOGICAL SURGERY. |