| CTRI Number |
CTRI/2026/04/108757 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic Validity |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Ultrasound-Based Clinical Scoring in Predicting Non-invasive Ventilation Failure in Emergency patients. |
|
Scientific Title of Study
|
The Accuracy Of Ultrasound Integrated Updated HACOR Score To Predict Non-Invasive Ventilation Failure In Acute Hypoxemic Respiratory Failure Patients In Emergency Department: A Prospective Observational Study. |
| Trial Acronym |
Sono U HACOR study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHANNABASAVA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department Of Emergency Medicine And Trauma
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, India Department Of Emergency Medicine And Trauma
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, India Pondicherry PONDICHERRY 605006 India |
| Phone |
8296254493 |
| Fax |
|
| Email |
channabasava80500@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
AMRITHANAND V T |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department Of Emergency Medicine And Trauma
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, India
email id -amrithanandvt@gmail.com Gmail id-amrithanandvt@gmail.com Pondicherry PONDICHERRY 605006 India |
| Phone |
8296254493 |
| Fax |
|
| Email |
amrithanandvt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
CHANNABASAVA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department Of Emergency Medicine And Trauma
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, India
Pondicherry PONDICHERRY 605006 India |
| Phone |
8296254493 |
| Fax |
|
| Email |
channabasava80500@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanavatrinagar JIPMER CAMPUS
Puducherry
Pincode 605006
INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Channabasava |
Emergency Medicine And Trauma Department JIPMER |
Jawaharlal Institute Of Postgraduate Medical Education And Research
Dhanvantari Nagar
Puducherry 605006 Pondicherry PONDICHERRY |
8296254493
channabasava80500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults more than or equal to 18 years with acute hypoxemic respiratory failure started on Non-Invasive Ventilation |
|
| ExclusionCriteria |
| Details |
1. Hypercapnic respiratory failure (PaCO2 More than 45mmHg)
2. Trauma patients
3. Patients with neuromuscular disorders
4. Patients who require emergency intubation within 1hour of Initiation of NIV
5. Patients on Non-Invasive Ventilation after extubation
6. Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non-invasive ventilation failure defined as need for Endotracheal intubation or death while on non-invasive ventilation |
Non-invasive ventilation failure Time Windows at baseline,1 Hour,6 Hour,12 Hour,24 Hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="271" Sample Size from India="271"
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)
|
29/04/2026 |
| 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="2" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [channabasava80500@gmail.com].
- For how long will this data be available start date provided 01-06-2027 and end date provided 01-06-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
All adult patients with age more than 18 years presenting to the emergency department with acute hypoxemic respiratory failure (PaO2 less than 60 mmHg or PaO2/FiO2 less than 300) and initiated on NIV will be screened for the study. The exclusion criteria included trauma patients, patients with neuromuscular disorders, requiring emergency intubation within 1 hours of arrival, initiated on NIV after extubation and pregnant patients.
The initiation of NIV in ED is at the treating physician’s discretion. The NIV is delivered to the patient through a fitted face mask on either Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Pressure Ventilation mode (BIPAP) to relieve dyspnea. Parameters are gradually titrated based on patients’ tolerance. The selection of the face mask size is based on the patient’s facial type. The straps of the mask will be fitted properly while remaining comfortable to the patient. Patients are placed in a semirecumbent position to avoid aspiration, assuming there is no contraindication to this position. Common indications to initiate on NIV in acute hypoxemic respiratory failure are clinical presentation of respiratory distress at rest (such as active contraction of the accessory inspiratory muscles or paradoxical abdominal motion), or PaO2 less than 60 mmHg at room air or PaO2/FiO2 less than 300 mmHg with supplemental oxygen. The Positive End Expiratory Pressure is usually maintained between 4 and 10 cm H2O. Inspiratory pressure is usually between 10 and 20 cm H2O. The fractional concentration of oxygen is set to achieve peripheral oxygen saturation targets greater than 92%. In addition, appropriate strategies are used to improve NIV tolerance, such as controlling leakage, keeping the anchoring system as comfortable as possible, providing adequate humidification, and administering sedation. Ventilation settings and continuous oximeter parameters will be monitored by attending physicians. If the respiratory distress is relieved and oxygenation improved, NIV will be used intermittently or completely liberated. If respiratory failure progressively deteriorates, intubation for invasive mechanical ventilation is performed. However, the decision to intubate is at the discretion of the attending physician. The need for intubation or cardiac arrest is defined as NIV failure.
We will collect baseline data, vital signs, and arterial blood gas (ABG) on arrival to the ED. Baseline data included age, gender, reason for NIV initiation, underlying disease, severity of disease (assessed by sequential organ failure assessment [SOFA] score), presence of septic shock, and presence of ARDS. The baseline data will be collected by the investigator from the case record. The vital signs included heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, and consciousness (Glasgow Coma Scale). An updated HACOR score will be calculated at NIV initiation in ED (T0) and 1(T1) hours later on NIV. Similarly, the lung ultrasound score and diaphragm exertion score will be calculated. The studies showed patients with updated HACOR scores of lessthan or equal to 7, 7.5–10.5, 11–14, and morethan 14, respectively, were classified as having a low, moderate, high, and very high probability of NIV failure. The primary outcome is NIV failure during 24 hours with follow-up. NIV failure was defined as the requirement of intubation or cardiac arrest after NIV. The NIV failure will be calculated during a 1 hour, 6-hour period, 12 hour, and 24 hour
The lung ultrasound scan is performed using a linear probe (4.2-13MHz). The lung ultrasound score consists of scanning a predetermined 12 zones (6 regions on each hemithorax) of the lung. Lung aeration of each region is graded between 0 to 3 depending on the ultrasound pattern visualized. In each region, points are allocated according to the following ultrasound pattern: normal = 0, well-defined B-lines = 1, coalescent B-lines = 2, and consolidation = 3. The total score for the LUS assessment therefore, ranges from 0 to 36.
The total lung ultrasound score of more than 18 is calculated as a value of high, and less than 18 as low probability for the lung ultrasound component of the Sono u-HACOR score.
Diaphragm Excursion Score measured -Patient with score less than 1.2 is considered high risk, and more than 1.2 is considered low risk for NIV failure
|