| CTRI Number |
CTRI/2024/05/067395 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Increase in respiratory rate in head injury patients admitted in trauma ICU |
|
Scientific Title of Study
|
Central neurogenic hyperventilation in isolated traumatic brain injury patient in trauma ICU ,a prospective cohort 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 |
Dr Ayush Anand |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09956081879 |
| Fax |
|
| Email |
ayushanand9009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences, BHU |
| Address |
Department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Trauma ICU,Trauma centre,BHU,VARANASI,PIN-221005 |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Anesthesiology, 1st floor, Sir Sundarlal Hospital, BHU,varansi,221005 |
| 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 |
| Dr Ayush Anand |
Institute of Medical Sciences, BHU |
Department of Anesthesiology offfice , 1st floor, Sir Sundarlal Hospital, BHU
Varanasi
UTTAR PRADESH |
09956081879
ayushanand9009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Of Medical Sciences_ethics_committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Isolated Traumatic brain Injury patients with age 18-60 with either sex |
|
| ExclusionCriteria |
| Details |
patents not giving consent and poly trauma patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of hyperventilation in isolated traumatic brain injury patients |
From 1st day of admission in ICU till the patient is hyperventilating |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Co-relation between type of brain injury and incidence of hyperventilation in that injury |
From 1st day of admission in ICU till the patient is hyperventilating |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/05/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ayushanand9009@gmail.com].
- For how long will this data be available start date provided 16-07-2026 and end date provided 16-07-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Central
neurogenic hyperventilation (CNH) is defined as a syndrome comprising normal or
elevated arterial oxygen tension, decreased arterial carbon dioxide tension,
and respiratory alkalosis, induced by lesions in the central nervous system in
absence of cardiac or pulmonary disease, stimulating compensatory hyperpnea. This
condition often causes vasoconstriction in the
brain, leading to reduced blood flow and a risk of cerebral ischemia.
Hypocapnia, can happen intentionally as a treatment for high pressure inside
the skull or unintentionally due to rapid breathing. Central neurogenic
hyperventilation is quite common, especially after subarachnoid hemorrhage,
but it hasn’t been extensively studied in people with different traumatic brain
injuries.CO2 plays a crucial role
in regulating blood vessels in the brain. When there is decreased carbon dioxide in the
blood (hypocapnia), it causes the blood vessels in the brain to constrict,
reducing blood flow and intracranial pressure. However, it’s essential to recognize
that excessive hyperventilation can also harm the brain’s
ability to use oxygen and increase the brain’s demand for oxygen, potentially
making cerebral ischemia worse or triggering it. Our aim is to find the incidence and factor responsible for hyperventilation in traumatic brain injury. |