| CTRI Number |
CTRI/2023/02/049570 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
26/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Removal of ventilator tube from patients in Neuro ICU and need for replacement : Prospective Study |
|
Scientific Title of Study
|
Incidence, Risk factors and Outcomes of Extubation failure in Neuro-critical care patients : A Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAKULPRASATH S |
| Designation |
SENIOR RESIDENT |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
| Address |
DEPARTMENT OF NEURO ANAESTHESIA AND NEURO CRITICAL CARE,
NIMHANS,
BANGALORE
Bangalore
KARNATAKA
560029
India |
| Phone |
9942173629 |
| Fax |
|
| Email |
rakulprasath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SRIGANESH K |
| Designation |
PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
| Address |
DEPARTMENT OF NEUROANAESTHESIA AND NEURO CRITICAL CARE,
NIMHANS,
BANGALORE
Bangalore
KARNATAKA
560029
India |
| Phone |
9481445949 |
| Fax |
|
| Email |
drsri23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAKULPRASATH S |
| Designation |
SENIOR RESIDENT |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
| Address |
DEPARTMENT OF NEUROANAESTHESIA AND NEURO CRITICAL CARE,
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9942173629 |
| Fax |
|
| Email |
rakulprasath@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES, BANGALORE |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
DEPARTMENT OF NEURO ANAESTHESIA AND NEURO CRITICAL CARE,
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES,
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 |
| RAKULPRASATH S |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
NEURO INTENSIVE CARE UNIT,
2nd FLOOR, NEURO CENTRE AND EMERGENCY BLOCK,
NIMHANS,
BANGALORE
Bangalore
KARNATAKA |
9942173629
rakulprasath@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: G978||Other intraoperative and postprocedural complications and disorders of nervous system, (2) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges, (3) ICD-10 Condition: C709||Malignant neoplasm of meninges, unspecified, (4) ICD-10 Condition: C710||Malignant neoplasm of cerebrum, except lobes and ventricles, (5) ICD-10 Condition: C711||Malignant neoplasm of frontal lobe, (6) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe, (7) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, (8) ICD-10 Condition: C714||Malignant neoplasm of occipital lobe, (9) ICD-10 Condition: C715||Malignant neoplasm of cerebral ventricle, (10) ICD-10 Condition: C716||Malignant neoplasm of cerebellum, (11) ICD-10 Condition: C717||Malignant neoplasm of brain stem, (12) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (13) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (14) ICD-10 Condition: C720||Malignant neoplasm of spinal cord, (15) ICD-10 Condition: C720||Malignant neoplasm of spinal cord, (16) ICD-10 Condition: C721||Malignant neoplasm of cauda equina, (17) ICD-10 Condition: C722||Malignant neoplasm of olfactory nerve, (18) ICD-10 Condition: C723||Malignant neoplasm of optic nerve, (19) ICD-10 Condition: C724||Malignant neoplasm of acoustic nerve, (20) ICD-10 Condition: C725||Malignant neoplasm of other and unspecified cranial nerves, (21) ICD-10 Condition: C729||Malignant neoplasm of central nervous system, unspecified, (22) ICD-10 Condition: A170||Tuberculous meningitis, (23) ICD-10 Condition: A171||Meningeal tuberculoma, (24) ICD-10 Condition: A178||Other tuberculosis of nervous system, (25) ICD-10 Condition: A179||Tuberculosis of nervous system, unspecified, (26) ICD-10 Condition: A810||Creutzfeldt-Jakob disease, (27) ICD-10 Condition: A89||Unspecified viral infection of central nervous system, (28) ICD-10 Condition: S060||Concussion, (29) ICD-10 Condition: S061||Traumatic cerebral edema, (30) ICD-10 Condition: S062||Diffuse traumatic brain injury, (31) ICD-10 Condition: S063||Focal traumatic brain injury, (32) ICD-10 Condition: S064||Epidural hemorrhage, (33) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (34) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, (35) ICD-10 Condition: S068||Other specified intracranial injuries, (36) ICD-10 Condition: S069||Unspecified intracranial injury, (37) ICD-10 Condition: G936||Cerebral edema, (38) ICD-10 Condition: G910||Communicating hydrocephalus, (39) ICD-10 Condition: G911||Obstructive hydrocephalus, (40) ICD-10 Condition: G912||(Idiopathic) normal pressure hydrocephalus, (41) ICD-10 Condition: G913||Post-traumatic hydrocephalus, unspecified, (42) ICD-10 Condition: G931||Anoxic brain damage, not elsewhereclassified, (43) ICD-10 Condition: G960||Cerebrospinal fluid leak, (44) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure, (45) ICD-10 Condition: G975||Postprocedural hemorrhage of a nervous system organ or structure following a procedure, (46) ICD-10 Condition: G976||Postprocedural hematoma and seromaof a nervous system organ or structure following a procedure, (47) ICD-10 Condition: G373||Acute transverse myelitis in demyelinating disease of central nervous system, (48) ICD-10 Condition: G700||Myasthenia gravis, (49) ICD-10 Condition: G822||Paraplegia, (50) ICD-10 Condition: G825||Quadriplegia, (51) ICD-10 Condition: G403||Generalized idiopathic epilepsy and epileptic syndromes, (52) ICD-10 Condition: G408||Other epilepsy and recurrent seizures, (53) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria includes all patients getting admitted to Neuro ICUs and on endotracheal tube at any point in Neuro ICUs |
|
| ExclusionCriteria |
| Details |
1. Patients who are tracheostomised before coming into Neuro ICUs
2. Refusal of consent to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Extubation failure in patients admitted in Neuro ICUs |
DAY 1 AFTER EXTUBATION
DAY 2 AFTER EXTUBATION
DAY 3 AFTER EXTUBATION
DAY 4 AFTER EXTUBATION
DAY 5 AFTER EXTUBATION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess risk factors associated with Extubation failure |
1. DAY OF ADMISSION IN ICU
2. DAY OF EXTUBATION
3. DAY OF RE INTUBATION |
To assess impact of Extubation failure on patient outcome in terms of
1. Duration of ICU and Hospital stay
2. Neurological status at ICU and hospital discharge |
1. Date of hospital admission
2. Date of ICU admission
3. Date of ICU discharge
4. Date of hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
14/02/2023 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients admitted to the Neuro Intensive Care Unit (NICU) may require intubation and mechanical ventilation because of the respiratory compromise from either central or peripheral neurological pathology. Liberation from invasive ventilation, that is, extubation, at the earliest possible time is a widely accepted principle in intensive care for reduced morbidity and better outcomes. For this, classic extubation criteria have been established in the general critical care setting, mainly targeting pulmonary function and cooperativeness of the patient. However, classic extubation criteria have failed to predict successful extubation in many studies on NICU patients. Both delayed and premature extubation increase the rates of complications, need for tracheotomy, and duration of intensive care unit (ICU) stay, morbidity and mortality. Thus, it is crucial to predict whether and when to extubate such patients. The decision to extubate a neuro critical care patient with residual impaired consciousness has a high degree of uncertainty of success and undesirability of incorrect prediction. The incidence of extubation failure in general ICU varies between 6 and 47%. The incidence of extubation failure in neuro critical care patients is around 19%. The definition of extubation failure varies substantially between studies from 48 hours to 7 days. Recently it has been proposed to extend the timeframe that captures > 90% of extubation failure. Based on this pragmatic approach, a 5-day time frame was selected to account for >90% of failure. Therefore, extubation failure is defined as the need for re-intubation within 5 days of the extubation. Parameters used to predict extubation failure can be categorized into parameters assessing respiratory mechanics, airway patency and protection and cardiovascular reserve and neurological factors. There is limited data available on the incidence of extubation failure in neuro ICU patients in our country, hence this study is intended to assess the incidence of extubation failure in neuro critical care patients, the risk factors and the outcomes associated with it.
|