| CTRI Number |
CTRI/2025/11/096900 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using breathing test scores and lung ultrasound to predict the need for Ventilator Support in COPD Patients During Flare-ups |
|
Scientific Title of Study
|
Predictive Value of HACOR Score Plus Lung Ultrasound Score [HACOR-LUS] for Prediction of Non-Invasive Ventilation (NIV) Failure in Acute Exacerbation of COPD (AECOPD) Patients: A Single-Centre Prospective Study |
| 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 Biswajit Naskar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Kalyani |
| Address |
Trauma and Emergency Medicine Department
Nadia
WEST BENGAL
741245
India |
| Phone |
6290074738 |
| Fax |
|
| Email |
biswajit.ems@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biswajit Naskar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Kalyani |
| Address |
Trauma and Emergency Medicine Department
Nadia
WEST BENGAL
741245
India |
| Phone |
6290074738 |
| Fax |
|
| Email |
biswajit.ems@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biswajit Naskar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Kalyani |
| Address |
Trauma and Emergency Medicine Department
Nadia
WEST BENGAL
741245
India |
| Phone |
6290074738 |
| Fax |
|
| Email |
biswajit.ems@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Kalyani |
| Address |
NH-34 Connector, Basantapur, Saguna, Kalyani, Nadia, West Bengal-741245 |
| Type of Sponsor |
Government 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 Biswajit Naskar |
All India Institute of Medical Sciences Kalyani |
Department Of Trauma & Emergency Medicine
Nadia
WEST BENGAL |
6290074738
biswajit.ems@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Hospitalized with a diagnosis of AECOPD requiring NIV
2. Informed consent obtained |
|
| ExclusionCriteria |
| Details |
1. Immediate need for intubation at presentation
2. Contraindications to NIV
3. Other causes of respiratory failure (e.g., pneumonia without COPD, pulmonary edema, neuromuscular disease)
4. Refusal of consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictive value of the combined HACOR score and Lung Ultrasound Score (LUS) that is HACOR-LUS value for NIV failure in patients with AECOPD. HACOR and LUS will be assessed at baseline (within 2 hours of NIV initiation) |
at baseline (within 2 hours of NIV initiation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To identify clinical & demographic factors associated with NIV failure.
2. To assess the ventilator days & weaning outcome in High HACOR-LUS score patients |
1-2 hours after NIV initiation |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
20/11/2025 |
| 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="6"
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 observational study is designed to assess whether the combination of the HACOR score (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) and the Lung Ultrasound Score (LUS) can enhance the prediction of non-invasive ventilation (NIV) failure in patients hospitalised due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD). NIV is a recognised treatment for respiratory failure related to AECOPD; however, about a third of patients experience NIV failure, which is linked to poor outcomes. Early detection of individuals likely to experience NIV failure is essential for prompt escalation to invasive ventilation and improved prognosis.
Around 140 adult patients with AECOPD requiring NIV will be recruited over a six-month period at the Department of Trauma and Emergency Medicine, AIIMS Kalyani. HACOR and LUS will be evaluated within 2 hours of starting NIV. The predictive capabilities of each score individually and their combined effect (HACOR-LUS), for NIV failure will be analyzed using ROC curve analysis and logistic regression.
The study aims to develop a straightforward, bedside composite model to assist clinicians in the early risk stratification and management of AECOPD patients undergoing NIV. |