| CTRI Number |
CTRI/2024/01/061143 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study to find out if a Scoring System can be used to predict whether a patient needs to be placed on an Invasive Ventilator. |
|
Scientific Title of Study
|
Prediction of Non-Invasive Ventilation Failure using Ratio Of Oxygenation(ROX) Index in Type 1 Respiratory Failure
patients |
| 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 NVSN Prasant |
| Designation |
DM Post Graduate Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department Of Critical Care Medicine, G -Block
Sri Ramachandra Institute of Higher Education and Research
No 1 , Ramachandra Nagar , Porur Chennai
No.1 Ramachandra Nagar, Porur
Chennai, Tamil Nadu,
India 600 116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9740825777 |
| Fax |
|
| Email |
nprasant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Renuka M.K |
| Designation |
Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine
Sri Ramachandra Institute of Higher Education and Research
No.1 Ramachandra Nagar, Porur
Chennai
No.1 Ramachandra Nagar, Porur
Chennai, Tamil Nadu,
600 116
Thiruvallur
TAMIL NADU
600 116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuramanujam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NVSN Prasant |
| Designation |
DM Post Graduate Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine
Sri Ramachandra Institute of Higher Education and Research
No.1 Ramachandra Nagar, Porur
Chennai.
No.1 Ramachandra Nagar, Porur
Chennai, Tamil Nadu,
600 116
Thiruvallur
TAMIL NADU
600 116
India |
| Phone |
9740825777 |
| Fax |
|
| Email |
nprasant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical Centre
No.1 Ramachandra Nagar, Porur
Chennai, Tamil Nadu,
India 600 116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1 Ramachandra Nagar, Porur Chennai, Tamil Nadu, India 600 116 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Renuka MK |
Sri Ramachandra Institute of Higher Education and Research |
Critical Care Unit G-block
No.1 Ramachandra Nagar, Porur Chennai India 600 116
Thiruvallur
TAMIL NADU |
8056126336
renuramanujam@gmail.com |
| Dr Renuka MK |
Sri Ramachandra Institute of Higher Education and Research |
C4-ICU Critical Care Department
No.1 Ramachandra Nagar, Porur Chennai, Tamil Nadu, India 600 116
Thiruvallur
TAMIL NADU |
8056126336
renuramanujam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, (2) ICD-10 Condition: I509||Heart failure, unspecified, (3) ICD-10 Condition: J189||Pneumonia, unspecified organism, (4) ICD-10 Condition: J989||Respiratory disorder, unspecified, (5) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Type 1 Respiratory failure only. |
|
| ExclusionCriteria |
| Details |
Type II Respiratory Failure
Use of Non Invasive Ventilation after extubation
NIV after High Flow Nasal Cannula failure.
NIV after accidental extubation.
Pregnant patients.
Low Glasgow Coma Scale |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine ability of ROX index to predict NIV
failure by using ROC curve. |
Baseline , 1 hour and 12 hours after initiation of Non - Invasive Mechanical Ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare ROX index & HACOR score in predicting NIV
failure.
To identify other clinical & laboratory parameters used to
predict NIV failure. |
Baseline ,1 hour & 12 hours after initiation of Non- Invasive Mechanical Ventilation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/01/2024 |
| 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 - NO
|
|
Brief Summary
|
Patients with Type 1 Respiratory failure are at a high risk for getting intubated and placed on mechanical ventilation. However , a clear scoring system is lacking which could help physicians take evidence based decisions for intubation. ROX index has been widely used for detecting failure of High Flow Nasal Cannula ( HFNC) in patients with Respiratory Failure.It was popularly used during the COVID 19 epidemic. This study will help us understand whether we can use this same scoring system and apply it to patients with type 1 respiratory failure. Early detection of NIV failure can help prevent complications associated with hypoxaemia. On the other hand, this scoring system may help in preventing unnecessary endotracheal intubation and the complications associated with mechanical ventilator such ventilator acquired pneumonia, ventilator-induced lung injury can be prevented. |