| CTRI Number |
CTRI/2024/11/076562 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of positioning and putting air into the abdomen on output of the heart measured using a non traumatic heart monitor during keyhole surgeries |
|
Scientific Title of Study
|
Effect of positioning and pneumoperitoneum on Cardiac Index measured using noninvasive cardiac output monitor (USCOM) during laparoscopic procedures in Trendelenburg and Reverse Trendelenburg position Academic trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dadichiluka Venkata Gayathri Smitha |
| Designation |
Junior resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Operation theatre,
Department of Anaesthesiology,
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522002
India |
| Phone |
8008660075 |
| Fax |
|
| Email |
dvgs2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSunit Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Operation Theatre,
Department of Anaesthesiology
AIIMS Mangalagiri
Andhra Pradesh
Guntur
ANDHRA PRADESH
522002
India |
| Phone |
9878984295 |
| Fax |
|
| Email |
sunit1410@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrEeswar M V |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Operation theatre,
Department of Anaesthesiology
AIIMS Mangalagiri
Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9878984295 |
| Fax |
|
| Email |
dreeshwarmv@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,AIIMS Mangalagiri,Guntur,522002,Andhra Pradesh ,India |
|
|
Primary Sponsor
|
| Name |
DVGayathri Smitha |
| Address |
House number 50,Kamakshinagar,near collectorate,Vizianagaram |
| 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 |
| DVGayathri Smitha |
AIIMS Mangalagiri |
Operation theatre,
Department of Anaesthesiology,
Guntur
ANDHRA PRADESH |
8008660075
dvgs2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PS1 and 2
2. Age: 18-65 years
3. Both sexes
4. Patients undergoing all laparoscopic surgeries which includes Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic cystectomy, laparoscopic hysterectomy
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Age less than 18year of age and more than 65 years age
3. ASA PS 3 and above
4. Pregnant patients
5. Patient with post burn contractures at the suprasternal notch
6. BMI more than 30 Kg/m2
7. Surgery more than 2hrs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure changes in cardiac index on CO2 insufflation |
T1
Pre-induction baseline value
T2
After general anesthesia and intubation
T3
5 mins after CO2 insufflation with standard intraabdominal pressure of 14 mmHg
T4
5 mins after Reverse Trendelenburg position at 10 degrees angle
T5
5 mins after Trendelenburg position at 10 degrees angle
T6
5 mins after CO2 deflation
T7
2hrs after CO2 deflation in post operative area
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure changes in Stroke volume
Cardiac output
Mean arterial pressure
Stroke volume variability and
Systemic vascular resistance
|
T1
Pre-induction baseline value
T2
After general anesthesia and intubation
T3
5 mins after CO2 insufflation with standard intraabdominal pressure of 14 mmHg
T4
5 mins after Reverse Trendelenburg position at 10 degrees angle
T5
5 mins after Trendelenburg position at 10 degrees angle
T6
5 mins after CO2 deflation
T7
2hrs after CO2 deflation in post operative area
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/12/2024 |
| 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="0"
Months="11"
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
|
Effect of positioning and pneumoperitoneum on Cardiac Index measured using non-invasive cardiac output monitor (USCOM) during laparoscopic procedures in Trendelenburg and reverse Trendelenburg positionUltrasonic cardiac output monitoring is a feasible, continuous-wave (CW) doppler-based method that measures CO quickly and economically noninvasively. A non-invasive ultrasound probe, temporarily placed in the suprasternal notch, measures Doppler flow at the aortic valve and determines the flow over a cardiac cycle (the velocity time integral (VTI). Hence we decided to use USCOM in our study to measure changes in the cardiac index in laparoscopic surgeries after placing the patients at Trendelenburg and reverse Trendelenburg positions for 5 mins Changes in cardiac index will be noted in various positions in the same patient so the effect of positioning will be noted. |