| CTRI Number |
CTRI/2024/11/076173 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using blood investigation to predict mechanical ventilation prediction in Neuromuscular disease(Gullian Barre syndrome) patients admitted in ICU |
|
Scientific Title of Study
|
Predictive role of Immune-Nutritional Indices and Muscle atrophy in determining ventilator management outcomes in Guillain-Barre Syndrome (GBS) Patients in the 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 Shweta S Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and
Neurocritical care National Institute of Mental Health and
Neurosciences Hosur Main Road Bangalore
Bangalore
KARNATAKA
560028
India |
| Phone |
9480829837 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta S Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and
Neurocritical care National Institute of Mental Health and
Neurosciences Hosur Main Road Bangalore
KARNATAKA
560028
India |
| Phone |
9480829837 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta S Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and
Neurocritical care National Institute of Mental Health and
Neurosciences Hosur Main Road Bangalore
KARNATAKA
560028
India |
| Phone |
9480829837 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neuroanaesthesia and Neurocritical Care National Institute of Mental Health and
Neurosciences Hosur Main road Bengaluru Karnataka-560028 |
|
|
Primary Sponsor
|
| Name |
Dr Shweta S Naik |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and
Neurocritical Care National Institute of Mental Health and
Neurosciences Hosur Main road Bengaluru Karnataka-560028 |
| 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 Shweta S Naik |
National Institute of Mental Health and Neurosciences |
Department of
Neuroanaesthesia and
Neurocritical Care
National Institute of
Mental Health and
Neurosciences Hosur
Main road Bengaluru
Karnataka-560028
Bangalore
KARNATAKA |
9480829837
neurodocms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neuroscience |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 – 75 years
2. GBS patients admitted to ICU
|
|
| ExclusionCriteria |
| Details |
1. Patients with trauma to lower limbs
2. Unable to get an ultrasound image
3. Refusal to give consent
4. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the predictive value of baseline immune-nutritional indices for muscle mass change in Guillain-Barre Syndrome (GBS) patients requiring mechanical ventilation. |
blood investigation done at baseline will be taken. muscle ultrasound at day 0, day 3 and discharge will be done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To determine the influence of immune-nutritional indices on ventilator management outcomes (tracheostomy, extubation, or non-intubation) in Guillain-Barre Syndrome patients |
blood investigation done at baseline will be taken. muscle ultrasound at day 0, day 3, day 7 and discharge will be done |
|
|
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)
|
13/11/2024 |
| 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="3"
Months="0"
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
|
This study aims to explore if immune-nutritional indices which are values derived from routine blood investigations like complete blood count, liver function tests and lipid profile and muscle loss can predict airway management outcomes in Guillain-Barré Syndrome (GBS) patients in the ICU. GBS is an autoimmune disorder that can progress quickly, causing muscle weakness and sometimes leading to breathing difficulties, which may require intensive respiratory support. Identifying early predictors for ventilator needs could improve care and resource management for these patients. The study will focus on assessing immune-nutritional indices, such as the Prognostic Nutritional Index (PNI) and Neutrophil-to-Lymphocyte Ratio (NLR), at ICU admission. These markers, which reflect inflammation and nutritional health, may help predict outcomes like tracheostomy, extubation, or avoiding intubation. Additionally, muscle atrophy, measured through ultrasound scans of the thigh muscle (rectus femoris), will be monitored to assess its impact on the length of ICU stay, days on ventilation, and hospital stay |