| CTRI Number |
CTRI/2021/03/031613 [Registered on: 01/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Eye nerve diameter measurement with USG after prolonged abdominal surgery |
|
Scientific Title of Study
|
Ultrasonic measurement of optic nerve sheath diameter in prolonged abdominal surgery (UMONDStudy). |
| Trial Acronym |
UMOND |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arunangshu Chakraborty |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, kolkata |
| Address |
Dr. Arunangshu Chakraborty
Dept of Anaesthesia, Critical Care and Pain,
Tata Medical center, Kolkata
14, MAR(EW), Newtown, Kolkata 700156
Rajarhat, Newtown, 700156
Kolkata
WEST BENGAL
700135
India |
| Phone |
8910324933 |
| Fax |
|
| Email |
dr.arunangshu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunangshu Chakraborty |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, kolkata |
| Address |
Department of Anaesthesia, Critical Care and Pain,
Tata Medical center,
14, MAR(EW), AA-3, Newtown, Kolkata 700156
Rajarhat, Newtown, 700156
Kolkata
WEST BENGAL
700156
India |
| Phone |
8910324933 |
| Fax |
|
| Email |
dr.arunangshu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunangshu Chakraborty |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, kolkata |
| Address |
Department of Anaesthesia, Critical Care and Pain,
Tata Medical center,
14, MAR(EW), AA-3, Newtown, Kolkata 700156
Rajarhat, Newtown, 700156
Kolkata
WEST BENGAL
700156
India |
| Phone |
8910324933 |
| Fax |
|
| Email |
dr.arunangshu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Critical Care and Pain,
Tata Medical center,
14, MAR(EW), AA-3, Newtown, Kolkata 700156 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Critical Care and Pain |
| Address |
Department of Anaesthesia, Critical Care and Pain,
Tata Medical center,
14, MAR(EW), AA-3, Newtown, Kolkata 700156 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Arunangshu Chakraborty |
Tata Medical Center |
Department of Anaesthesia, Critical Care and Pain,
Tata Medical center,
14, MAR(EW), AA-3, Newtown, Kolkata 700156
North Twentyfour Parganas
WEST BENGAL |
8910324933
dr.arunangshu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center IRB |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Abdominal surgery lasting for more than 4 hours |
|
| ExclusionCriteria |
| Details |
Known retinal disease
Known optic disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative variation of optic nerve sheath diameter |
Measurement of optic nerve sheath diameter preoperatively and postoperatively before extubation/ in ICU in case if Patient is shifted intubated to icu |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conjunctival edema associated? yes/ no |
before and at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/03/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
•Prolonged abdominal surgery incurs large amount of blood loss, rapid fluid replacement and fluid shifts across physiological barriers causing tissue edema and raised ICP. •Added conditions such as- pneumoperitonium, trendelenberg position increase ICP further. •Raised ICP is reflected in Optic nerve sheath diameter (ONSD) as the ON is surrounded by dural sheath and increased CSF pressure causes the sheath to swell. ONSD measured at 3 mm below the optic disc using a high frequency linear ultrasound transducer (UST) is •Safe, reliable, >90% accuracy •Can be performed by any anaesthesiologist with some training in point of care ultrasound (POCUS). The primary objective of the study is to develop a model which can predict the change in ONSD after surgery based on various clinical and intraoperative parameters. We will model the difference in OND using a linear regression model with prespecified parameters, mainly- 1.Prolonged duration 2.Trendelenberg position (head down) 3.Pneumoperitonium (laparoscopy) |