| CTRI Number |
CTRI/2025/02/080389 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare how the HACOR score and ROX index help in predicting the failure of non-invasive ventilation (NIV) among patients with low level of oxygen in the blood. |
|
Scientific Title of Study
|
Comparing HACOR (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) score and ROX (Respiratory rate Oxygenation) index as a predictor of non invasive ventilation failure in acute hypoxemic 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 |
Anush Gowda A S |
| Designation |
Postgraduate Student in Respiratory Therapy |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
2nd Floor, Department of Respiratory Therapy, Kasturba Medical College Centre for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9066760837 |
| Fax |
|
| Email |
anushgowda2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautham Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
2nd Floor, Department of Respiratory Therapy, Kasturba Medical College Centre for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9113647963 |
| Fax |
|
| Email |
hamgautham1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautham Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
2nd Floor, Department of Respiratory Therapy, Kasturba Medical College Centre for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9113647963 |
| Fax |
|
| Email |
hamgautham1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Hospital,
Nandigudda road, Attavar, Mangalore 575001 Dakshina Kannada KARNATAKA |
| KMC Hospital, Dr.B ,R.Ambedkar Circle, Hampankatta, Mangaluru 575001 Dakshina Kannada KARNATAKA |
|
|
Primary Sponsor
|
| Name |
Anush Gowda A S |
| Address |
Kasturba Medical College, Light House Hill Road, Mangalore, Karnataka 575001 |
| 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 Sumesh T Rao |
Kasturba Medical College Hospital |
MICU, 5th Floor, Kasturba Medical College Hospital, Nandigudda road, Attavar, Mangalore 575001
Dakshina Kannada
KARNATAKA |
9066760837
anushgowda2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Use of non invasive ventilation via oronasal mask. |
|
| ExclusionCriteria |
| Details |
1)Patients aged above 80 years. 2)Use of HFNC before NIV. 3)Rescue and prophylactic use of non invasive ventilation after extubation. 4)Chest trauma. 5)Obstetric patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the HACOR [heart rate, acidosis (arterial pH), consciousness (Glasgow Coma Scale), oxygenation, and respiratory rate] score and ROX (Respiratory rate Oxygenation) index in predicting non invasive ventilation (NIV) failure. |
The outcome will be assessed at before initiating the non invasive ventilation (NIV), after 2 hours, and after 12 hours of initiation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of invasive mechanical ventilation, duration of ICU stay, & 28 day mortality. |
Mortality will be assessed exactly 28 days after NIV initiation. |
|
|
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)
|
01/03/2025 |
| 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="0"
Months="10"
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 is a prospective observational study that aims to compare the HACOR (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) Score and the ROX (Respiratory rate–Oxygenation) Index in predicting the failure of non-invasive ventilation (NIV) in patients with acute hypoxemia in around 100 patients. The patients will be selected based on the inclusion criteria and consecutive sampling method. The patients who are undergoing non invasive ventilation (NIV) will be assessed for NIV status before initiating the NIV, after 2 hours and 12 hours of initiation using HACOR and ROX index. The primary outcome is to compare the HACOR score and ROX index in predicting non invasive ventilation failure. The secondary outcome will be the duration of invasive mechanical ventilation, duration of ICU stay, and 28 day mortality. The final results will be interpreted using ROC (Receiver Operating Characteristic) analysis, comparing the AUC (Area Under The Curve) for both score. The score which has higher AUC indicates a better predictive ability for the outcome. |