| CTRI Number |
CTRI/2022/02/040001 [Registered on: 03/02/2022] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
assessment of gradual withdrawal from ventilator in neurosurgical patients |
|
Scientific Title of Study
|
Evaluation of predictors of successful weaning and extubation in neurosurgical patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidya Sriram |
| Designation |
Senior Resident |
| Affiliation |
NIMHANS |
| Address |
Department of neuroanaesthesia and neurocritical care
faculty building,
Third floor
Nimhans hospital
NIMHANS HOSPITAL
Bangalore
KARNATAKA
560004
India |
| Phone |
9820817922 |
| Fax |
|
| Email |
vidyasriram1803@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Bhadrinarayan |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of neuroanaesthesia and neurocritical care
Faculty building
Nimhans hospital
NIMHANS HOSPITAL
Bangalore
KARNATAKA
560029
India |
| Phone |
9448084257 |
| Fax |
|
| Email |
n_bhadri@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya Sriram |
| Designation |
Senior Resident |
| Affiliation |
National institute of mental health and neurosciences |
| Address |
Department of neuroanaesthesia and neurocritical care
faculty building,
Third floor
c
National institute of mental health and neurosciences HOSPITAL
bangalore
560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9820817922 |
| Fax |
|
| Email |
vidyasriram1803@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIMHANS Hospital |
| Address |
NIMHANS Hospital ,Hombegowda nagar Bangalore |
| 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 Vidya |
ICU NIMHANS HOSPITAL |
Surgical Icu ,Second floor
Nimhans hospital
Bangalore
KARNATAKA |
9820817922
vidyasriram1803@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All neurosurgical patients who are mechanically ventilated for more than 48 hours in ICU |
|
| ExclusionCriteria |
| Details |
Leisons compressing the brainstem
Pregnant patients
Patients relative refusal
Patients on beta blockers or rate controlling drugs Patients with diaphragm dysfunction
Patients with severe left ventricular dysfunction
Patients with rib fractures or thoracotomy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful weaning and extubation |
1)At 48 hours of mechanical ventilation
2)At the beginning and end of the spontaneous breathing trial
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Successful extubation |
24 hours prior to extubation |
|
|
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)
|
10/02/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After taking a written informed consent, we plan to do a prospective study on patients who are intubated and mechanically ventilated in the ICU for more than 48 hours. Discontinuation of mechanical ventilation /weaning will be attempted according to the clinical judgement of the treating physician. Data will be collected at the following time points 1)At the end of 48 hours of mechanical ventilation 2)At the beginning of the first spontaneous breathing trial 3)24 hours prior to extubation The following parameters will be recorded 1)Heart rate variability 2)Respiratory rate 3)PaO2/FiO2 ratio 4)Haemoglobin 5)Rapid shallow breathing index 6)Diaphragm excursion and Diaphragm thickness fraction
|