| CTRI Number |
CTRI/2021/11/038297 [Registered on: 26/11/2021] Trial Registered Prospectively |
| Last Modified On: |
23/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of expired carbon-dioxide and blood carbon dioxide in robotic surgeries |
|
Scientific Title of Study
|
Correlation of end-tidal carbon dioxide and arterial carbon dioxide during robotic surgeries requiring pneumoperitoneum |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jibina Susan Issac |
| Designation |
MD Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences,Edapally, Ponnekara PO,
Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
9048331317 |
| Fax |
|
| Email |
jibsusis@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shyam Sundar P |
| Designation |
professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences,Edapally, Ponnekara PO,
Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
9895093011 |
| Fax |
|
| Email |
drshyamsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jibina Susan Issac |
| Designation |
MD Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences,Edapally, Ponnekara PO,
Ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
9048331317 |
| Fax |
|
| Email |
jibsusis@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| department fund, Amrita institute of Medical Scienes, department of Anesthesiology and critical care |
|
|
Primary Sponsor
|
| Name |
Amrita Hospital |
| Address |
Amrita Istitute of Medical Scienec, Ponekkara, Kochi, 682041 |
| 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 |
| jibina susan issac |
Amrita Institute of Medical Scienes |
Department of Anesthesiology and critical care, Amrita Istitute of Medical Scienes, Ponekkara PO, Kochi, 682041
Ernakulam
KERALA |
9048331317
jibsusis@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy hepatic donors |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients above 18-60 years of age undergoing robotic donor hepatectomy |
|
| ExclusionCriteria |
| Details |
1) if the surgery id converted to open procedure.
2) If the patient has COPD |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation of end tidal carbon dioxide (ETCO2) and arterial carbon dioxide (PaCO2) in patients undergoing robotic donor hepatectomy under general anaethesia. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess correlation of MAP and SBP with pneumoperitoneum at different time points. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/12/2021 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Robotic donor hepatectomy is a relatively new procedure which takes more than 5 hours. Monitoring of PaCO2 is important for long duration surgeries where capnoperitoneum is created. ETCO2 is a continuous, non invasive surrogate of PaCO2. Continuous ETCO2 monitoring will give an approximate value of the corresponding PaCO2. So, if the correlation between the two are good we can reduce the number of blood gas sampling during long duration robotic surgeries requiring pneumoperitoneum.
|