| CTRI Number |
CTRI/2025/03/081801 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Incentive Spirometry] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Breathing exercise in patients after surgery for bleeding on the surface of the brain. |
|
Scientific Title of Study
|
Role of Incentive Spirometry after Burr Hole Evacuation of Chronic Subdural Hematomas: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAHUL SAIKIA |
| Designation |
DrNB Neurosurgery Resident, Institute of Neurosciences, Kolkata |
| Affiliation |
Institute of Neurosciences, Kolkata |
| Address |
Department of Neurosurgery, Institute of Neurosciences Kolkata. 185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata. PIN-700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
8638782018 |
| Fax |
|
| Email |
rahuldbrt1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PARTHA GHOSH |
| Designation |
Consultant Neurosurgeon, Institute of Neurosciences, Kolkata |
| Affiliation |
Institute of Neurosciences, Kolkata |
| Address |
Department of Neurosurgery, Institute of Neurosciences, Kolkata. 185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata. PIN-700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
9007750929 |
| Fax |
|
| Email |
ghoshparthanrs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PARTHA GHOSH |
| Designation |
Consultant Neurosurgeon, Institute of Neurosciences, Kolkata |
| Affiliation |
Institute of Neurosciences, Kolkata |
| Address |
Department of Neurosurgery, Institute of Neurosciences, Kolkata. 185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata. PIN-700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
9007750929 |
| Fax |
|
| Email |
ghoshparthanrs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences Kolkata.
185, Acharya Jagadish Chandra Bose Road, Elgin Kolkata, West Bengal, India, PIN-700017. |
|
|
Primary Sponsor
|
| Name |
RAHUL SAIKIA |
| Address |
Department of Neurosurgery, Institute of Neurosciences Kolkata, 185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata, West Bengal, India, PIN-700017. |
| Type of Sponsor |
Other [Self] |
|
|
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 PARTHA GHOSH |
Institute of Neurosciences, Kolkata |
Department of Neurosurgery (Neurosurgery Unit 2 and Neurosurgery Unit 3). 185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata, PIN-700017
Kolkata
WEST BENGAL |
9007750929
ghoshparthanrs@gmail.com |
|
|
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 |
| Patients |
(1) ICD-10 Condition: I620||Nontraumatic subdural hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Incentive Spirometry |
Incentive spirometer is a hand-held breathing device that consists of 3 chambers in a row, with a ball inside each row. On holding the device upright the patient will be advised to breathe in through the mouth-piece which will raise the balls depending on the volume of air inspired. The device will then be turned upside-down and then the patient will again be advised to breath out through the mouth-piece which will again raise the balls depending on the volume of air expired. Incentive Spirometry will be started in the Intervention group (spirometry group) after burr hole evacuation of chronic SDH during the post-operative period as well as after discharge. Patients will be advised for doing both the inspiratory and expiratory phases of spirometry for about 10-15 times a day, with each time consisting of 5 inspiratory and 5 expiratory phases. Patients will be followed up after 1 and 3 month with CT brain. Depending on the residual subdural space on CT they will be regarded as resolution or recurrence. |
| Comparator Agent |
Non Spirometry |
Patients in the comparator group after burr hole evacuation of chronic SDH will be routinely discharged and not be given incentive spirometry exercise. They will be followed up at 1 and 3 months with CT brain. Depending on the residual subdural space on CT they will be regarded as resolution or recurrence. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with CT scans suggestive of chronic subdural hematoma undergoing burr hole evacuation.
2.Patients with GCS more than 13.
|
|
| ExclusionCriteria |
| Details |
1.Patients with acute subdural hematoma.
2.Patients with chronic subdural hematoma and GCS less than equal to 13.
3.Patients with contraindications for spirometry (e.g. recent MI, unstable angina, bullous emphysema)
4.Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the recurrence rate following burr-hole evacuation. |
The follow-up CT brain will be at 1 and 3 months to detect any recurrence |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the resolution of chronic SDH following burr hole evacuation |
The follow-up CT brain will be done at 1 and 3 months to check for resolution |
|
|
Target Sample Size
|
Total Sample Size="444"
Sample Size from India="444"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="2"
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
|
Chronic subdural hematomas are a common clinical
condition encountered in day-to-day neurosurgical practice. Management of chronic subdural hematomas may be
either surgical or conservative. Burr hole drainage is currently the most common
surgery used worldwide for the treatment of chronic subdural hematomas. However, recurrence after surgical evacuation is a common problem and has been found to occur in
the range of (5-30)%. A number of factors are associated with post-operative
recurrence following surgical evacuation such as male gender, elderly age group, bilateral hematoma
etc. Several adjuvant therapies with surgery are
investigated for preventing recurrence which includes corticosteroids,
atorvastatin and middle meningeal artery embolization. 3 ball incentive spirometry has been used in our
institution following subdural hematoma evacuation to prevent recurrence. The main mechanism
driving this idea is to increase the intracranial pressure and promote brain
expansion which ultimately results in drainage of blood products. Hence, this study is conducted to analyze the effect of incentive spirometry in preventing recurrence following burr-hole evacuation of chronic subdural hematoma. |