| CTRI Number |
CTRI/2024/05/067981 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Changes in blood flow of brain after surgery |
|
Scientific Title of Study
|
Cerebrodynamic Changes Following Cranioplasty Using a
Point-of-care Ultrasound: A Prospective Observational
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 |
Kiran Jangra |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute Of Medical Education And Research |
| Address |
Dept of Anaesthesia and Intensive Care 4th Floor Nehru Hospital Chandigarh CHANDIGARH 160012 India |
| Phone |
9914844330 |
| Fax |
|
| Email |
drkiransharma0117@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nivedita RK |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute Of Medical Education And Research |
| Address |
Dept of Anaesthesia and Intensive Care 4th Floor Nehru Hospital Chandigarh CHANDIGARH 160012 India |
| Phone |
7708355354 |
| Fax |
|
| Email |
rknivy26@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kiran Jangra |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute Of Medical Education And Research |
| Address |
Dept of Anaesthesia and Intensive Care 4th Floor Nehru Hospital Chandigarh CHANDIGARH 160012 India |
| Phone |
9914844330 |
| Fax |
|
| Email |
drkiransharma0117@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medcal Education and Research, Sector 12, Chandigarh, India. PIN: 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Reseach |
| Address |
department of Anaesthesia, 4th floor, B Block, Nehru Hospital, Chandigarh, 160012 |
| 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 |
| Kiran Jangra |
PGIMER Chandigarh |
Dept of Anaesthesia and Intensive Care
4th Floor Nehru Hospital
PGIMER Chandigarh CHANDIGARH |
9914844330
drkiransharma0117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients with craniectomy defects
2. Posted for cranioplasty in the age group between
18-65 years will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
Patient refusal
• Lumbar drain / CSF drainage before during study period
• Sepsis
12
• Known cardiac illness
• Poor window
• Known case of arteritis and major cerebral vasculature stenosis
• Patients with the history of ischemic stroke or transient ischemic attacks |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the changes in ICP of ipsilateral Middle cerebral artery using Pulsatility
index (PI) before and one hour post cranioplasty |
one-hour post cranioplasty. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the changes in anterior, middle, and posterior cerebral artery flow
velocities before and after cranioplasty. |
one-hour post cranioplasty. |
| To compare the pulsatility index (PI) on both sides before and after cranioplasty. |
one-hour post cranioplasty. |
To evaluate the neurological outcome post cranioplasty using Modified Rankin scale at
discharge and GOS-E at 3 months. |
3 months. |
| To observe the changes in the preoperative symptoms after cranioplasty. |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
10/06/2024 |
| 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="1" 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
|
Decompressive craniectomy (DC) is the third most common neurosurgical procedure for treating TBI in India. Cranioplasty is one of the common neurosurgical procedures usually performed post decompressive craniectomy, to protect the underlying cerebral structures. The purpose of cranioplasty is not only to improve cosmesis but also to prevent neurological deterioration. Post-DC patients with large cranial defects are prone to develop the “syndrome of Trephined†also known as the “Sinking skin flap syndrome†which is manifested as dizziness, headache, seizures, motor deficits and language disturbances. The aim of this prospective, observational study is to compare the changes in ICP (derived by Pulsatility Index of ipsilateral MCA) before and after cranioplasty using transcranial ultrasound. TCCD examinations will be performed before induction using a phased array 1-5 MHz probe (GE LOGIQ machine) through the transtemporal window. The transducer probe will be placed over the temporal area just above the zygomatic arch in front of the tragus of the ear with the pointer facing medially. Before the examination, TCD will be performed under the same physiological conditions including the heart rate, blood pressure, temperature, and hematocrit pre- (before induction) and post-cranioplasty (1 hour after surgery). The Doppler spectrum of all the cerebral arteries will be obtained by 0 0-degree angle of insonation. |