| CTRI Number |
CTRI/2025/07/091681 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
A study assessing the spinal cord catheter placement for patients coming for csf leak repair surgery |
|
Scientific Title of Study
|
A prospective observational study on CSF lumbar drain placement for endoscopic CSF leak repair in patients diagnosed with spontaneous CSF leak |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahavi R |
| Designation |
Assistant professor |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology
Christian medical college and hospital
Vellore
Department of Anaesthesiology
Christian medical college and hospital, Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9442763053 |
| Fax |
|
| Email |
rahavirajendran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naveen Kumar S |
| Designation |
Assistant professor |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Cardiac Anaesthesia
Christian Medical College and Hospital,
Thottapalayam
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9885520970 |
| Fax |
|
| Email |
suda.naveen@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Naveen Kumar S |
| Designation |
Assistant professor |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Cardiac Anaesthesia
Christian Medical College and Hospital
Thottapalayam
VELLORE
Vellore
TAMIL NADU
632004
India |
| Phone |
9885520970 |
| Fax |
|
| Email |
suda.naveen@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| christian medical college and hospital
thottapalayam
vellore
PIN :632004 |
|
|
Primary Sponsor
|
| Name |
christian medical college and hospital |
| Address |
Christian medical college and Hospital , Vellore. |
| 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 |
| Rahavi R |
Christian medical college and hospital |
ENT Operating theatres -22,23,24 and 25 , ENT RECOVERY ROOM and ENT ward
Vellore
TAMIL NADU |
9442763053
rahavirajendran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G988||Other disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II and III
Patients between 18-75 years of age
Elective CSF LEAK REPAIR surgery |
|
| ExclusionCriteria |
| Details |
ASA 4 and above
emergency surgery
patient refusal
age more than 80 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The time taken for placement of the LSAD with the two different techniques
being used ( USG and landmark based techniques).
|
Intra-operative and the post-operative periods. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts required for LSAD placement using two different techniques (USG or
landmark based technique)
Any complications such as bloody tap and PDPH associated with the LSAD placement |
intraoperative and postoperative period |
|
|
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)
|
25/07/2025 |
| 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 Yet Recruiting |
| 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
|
Measurement and monitoring of intracranial pressure play vital roles in diagnostic and
therapeutic procedures. Different methods of measuring intracranial pressure involve both
invasive and noninvasive techniques. Both invasive and non-invasive techniques of
intracranial pressure monitoring have their advantages and disadvantages. Out of all the
techniques of measurement of intracranial pressure, measurement of ICP via lumbar
puncture/ drain is one of the less invasive techniques. But lumbar puncture / lumbar
catheter placement needs expertise, and it is time consuming.The purpose of our study is to formulate a protocol / guide in performing a lumbar
puncture/ lumbar drain placement procedure. One of the major priorities will be in
reducing the time requirement while performing the procedure. There are different
techniques of placement of lumbar drain catheter. We would like to observe and formulate
a protocol which suggests the technique with minimal duration, decreasing the number of
attempts of placement. We would also like to observe the technique with minimal
hemodynamic changes.Patients posted for Spontaneous CSF leak repair and patients requiring
preoperative lumbar drain placement between age groups 18- 75 years of age, in the ASA
classification I TO III will be approached for informed consent by the principal investigator
on the evening prior to surgery and recruited.Preoperatively patient’s demographics, diagnosis, the proposed
surgery, the indication for lumbar drain placement, comorbidities of the patient,
examination of the patient and the baseline investigations will be assessed and documented
by the principal investigator.
Standard fasting guidelines will be followed by and premedication if indicated will be given
with tablet lorazepam/tablet diazepam. In the operating theatre, a peripheral line which is
a part of the routine anesthetic procedure will be started.In the operating room IV access will be established under local anaesthesia and ASA
(American Society of Anaesthesiologists) standard monitoring will be established with
SpO2, ECG, NIBP and EtCO2. The baseline vitals (heart rate, blood pressure, skin
temperature, consciousness level) will be recorded. Vital signs will be monitored during the
procedure (every 5 minutes) for the complete duration of the surgery and the monitoring
will be continued in the recovery room, till the time the patient is ready for discharge from
the post anaesthesia care unit. The CSF pressure during the lumbar drain placement will be
recorded and documented. Continuous temperature recording will be done.We will also record the technique of lumbar drain placement, the position of the patient,
procedure done under either local anaesthesia/ general anaesthesia, the type and gauge of
the needle used for the catheter placement, the number of attempts of placement, any
complications during the procedure. The total duration of the procedure, the amount of CSF
drained every hour (intra-operatively), the intraoperative blood loss during the surgery.
Postoperatively if the patient is stable, they will be shifted to the post-anesthesia care unit
(PACU) or recovery room for immediate post-operative monitoring. If the patient requires
continued hemodynamic and ventilatory care, ICU admission will be mandated. This will be
documented.
Post-operative parameters:
In the post-operative period, we will follow up on the patient till the day the lumbar drain
catheter is removed. We will observe, assess and document the following postoperative
details such as the total volume of CSF drained, any complications such as kinking, occlusion
of the catheter, blood-tinged CSF in the catheter and the number of postoperative days that
the catheter is kept in situ.
|