| CTRI Number |
CTRI/2021/11/038051 [Registered on: 15/11/2021] Trial Registered Prospectively |
| Last Modified On: |
14/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Surgical Position related Changes of Intraabdominal pressure in neurosurgery |
|
Scientific Title of Study
|
Surgical Position Associated Intra-abdominal Pressure (IAP) changes in Neurosurgery : The SPAIN study |
| Trial Acronym |
SPAIN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Debbarman |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department Of Neuroanaesthesia and critical care 6th floor CN centre AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
7005978936 |
| Fax |
|
| Email |
sagar4848@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surya Kumar Dube |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department Of Neuroanaesthesia and critical care 6th floor CN centre AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9013172155 |
| Fax |
|
| Email |
drskdube@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surya Kumar Dube |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department Of Neuroanaesthesia and critical care 6th floor CN centre AIIMS New Delhi
DELHI
110029
India |
| Phone |
9013172155 |
| Fax |
|
| Email |
drskdube@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES ( AIIMS) NEW DELHI, ANSARI NAGAR , NEW DELHI 110030 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Ansari Nagar east New Delhi Delhi 110029 |
| Type of Sponsor |
Government 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 |
| Dr Sagar Debbarman |
AIIMS New Delhi |
Department of Neuroanaesthesia and critical care, 6th floor CN Centre , AIIMS New Delhi
South
DELHI |
7005978936
sagar4848@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients of ASA I & II category (18 to 60 years of age) scheduled to undergo craniotomy for elective neurosurgical procedures |
|
| ExclusionCriteria |
| Details |
1 Emergency neurosurgical cases.
2 Patients with active abdominal pathology (eg: Liver disease and kidney disease, abdominal trauma etc) and/or preoperative hepatic or renal impairment.
3 Contraindication to bladder catheterisation (eg: bladder surgery, injury, urethral strictures etc)
4 Preoperative haemodynamic instability.
5 Pregnancy, Morbid obesity. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the change of Intraabdominal pressure (IAP) from the baseline in different neurosurgical positions intraoperatively |
O day and upto 3rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the impact of intra-operative IAP changes with post-operative hepatic and renal function. |
From the day of surgery to 3 post operative days . |
| To study the impact of intra-operative IAP changes with ICU stay, hospital stay and the neurological outcome. |
From the day of surgery till hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/11/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective single center observational study , where Intra abdominal pressure changes will be ,monitored in different neurosurgical positions , like supine , prone, lateral and sitting . Secondary outcome will be to the impact of intraoperative IAP changes in post operative hepatic and renal function & on duration of ICU stay, hospital stay and neurological outcome ( using GOS ) . IAP will be measured using intravesical catheter technique Intraoperatively , and post operatively for 24 hour. Post operatively LFT and KFT will be done daily for 72 hours and renal injury status will be accessed using AKIN criteria. |