| CTRI Number |
CTRI/2024/11/076753 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Why patients require continued ventilator support for breathing in ICU. |
|
Scientific Title of Study
|
Incidence of extubation failure and its predictors among adult patients in neuro-intensive care unit |
| 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 Eman Aftab |
| Designation |
Senior resident Neuroanesthesia |
| Affiliation |
sher-e-kashmir institute of medical sciences |
| Address |
Room 2A,2nd floor, NICU,Sher-e-kashmir institute of medical sciences,Soura
Srinagar
JAMMU & KASHMIR
190001
India |
| Phone |
7006886034 |
| Fax |
|
| Email |
justme_eman@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zulfiqar Ali |
| Designation |
additional professor |
| Affiliation |
sher-e-kashmir institute of medical sciences |
| Address |
Room 2A,2nd floor, NICU,Sher-e-kashmir institute of medical sciences,Soura
Srinagar
JAMMU & KASHMIR
190001
India |
| Phone |
7006886034 |
| Fax |
|
| Email |
doctorpain14@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Eman Aftab |
| Designation |
Senior resident Neuroanesthesia |
| Affiliation |
sher-e-kashmir institute of medical sciences |
| Address |
Room 2A,2nd floor, NICU,Sher-e-kashmir institute of medical sciences,Soura
JAMMU & KASHMIR
190001
India |
| Phone |
7006886034 |
| Fax |
|
| Email |
justme_eman@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shereekashmir institute of medical sciences |
| Address |
Shere-e-kashmir institute of medical scinces, skims, soura,Jammu and Kashmir,India,190001 |
| 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 Eman Aftab |
Shere-e-kashmir institute of medical sciences |
Ward 2A,2nd floor, near OT complex,Soura
Srinagar
JAMMU & KASHMIR |
700686034
justme_eman@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Skims |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V020||Pedestrian injured in collision with two- or three-wheeled motor vehicle in nontraffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients above the age of 18
At patients admitted to the ICU with neurosurgical diagnosis |
|
| ExclusionCriteria |
| Details |
Patients admitted for reasons other than neurological causes
Paediatric patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of extubation failure in neurosurgical ICU |
1st week, 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Causes of extubatiom failure |
Roughly 6 months study |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
04/11/2027 |
| 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="0"
Months="6"
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
|
Extubation can be tricky in neurosurgical patients. They have edema, vasospasm, bleed which can cause extubation failure and lead to reintubation. The purpose of our study was to find the causes of extubation failure in neurosurgical patients so that we could avoid reintubations in these patients and improve outcome.
|