| CTRI Number |
CTRI/2026/04/108656 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
study to assess whether a clinical scoring system and blood test can predict failure of non invasive ventilation in patients with severe breathing difficulty |
|
Scientific Title of Study
|
Evaluation of the Heart rate Acidosis Consciousness Oxygenation Respiratory rate HACOR Score as a Predictor of Non-Invasive Ventilation Failure in Patients with Hypoxemic Respiratory Failure |
| Trial Acronym |
Heart rate Acidosis Consciousness Oxygenation Respiratory rate |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHINI RAMAKANT PATIL |
| Designation |
General Medicine Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Kle hospital belgavi
Belgaum
KARNATAKA
590001
India |
| Phone |
8600451300 |
| Fax |
|
| Email |
mrpatil788@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANJALI R METGUDMATH |
| Designation |
General Medicine Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Kle hospital belgavi
Jawaharlal Nehru Medical College
Belgaum
KARNATAKA
590001
India |
| Phone |
O8312437769 |
| Fax |
|
| Email |
metgudanjali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHINI RAMAKANT PATIL |
| Designation |
General Medicine Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Kle belgavi
Jawaharlal Nehru Medical College
KARNATAKA
590001
India |
| Phone |
8600451300 |
| Fax |
|
| Email |
mrpatil788@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College and Hospital |
| Address |
JNMC Campus, JNMC KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 Mohini Ramakant Patil |
KLE DR PRABHAKAR KORE HOSPITAL AND MRC |
JNMC KLE University general medicine department
Belgaum
KARNATAKA |
8600451300
mrpatil788@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
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 |
All patients above age of 18 years admitted in medical intensive care unit requiring
non-invasive ventilation fulfilling the criteria of Hypoxemic Respiratory failure:
1)Partial pressure of oxygen( PA02)<60
2)Partial pressure of carbon dioxide (PACO2)- Normal/Decreased |
|
| ExclusionCriteria |
| Details |
1)Pregnancy
2)Patients who directly require Mechanical ventilation.
3)Hypercapnic Respiratory failure.
4)Patients who underwent the use of non-invasive ventilation after extubation.
5)Patient who had undergone non-invasive ventilation more than 2hrs before being
admitted in medical intensive care unit.
6)Upper airway obstruction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in HACOR score between 0 and 24 hours.
2. Correlation between HACOR score and NIV failure. |
0 and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of NIV failure
2. ICU length of stay
3. ICU mortality
4. Hospital mortality |
0 and 24 hrs, till discharge or death |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
30/04/2026 |
| 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
|
Hypoxemic respiratory failure is commonly managed with non-invasive ventilation, but delay recognition of NIV failure increases morbidity mortality hacker score, helps predict NIV failure This prospective observational study helps to evaluate the hacor score in predicting NIV failure |