| CTRI Number |
CTRI/2025/07/091120 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Is HACOR score better than ultrasound of respiratory muscles in assessing outcomes of breathing support administered by face mask |
|
Scientific Title of Study
|
Comparison of HACOR scoring system with Diaphragm ultrasound in predicting outcomes of non-invasive ventilation - A prospective observational 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. Theyjes |
| Designation |
Post-Graduate |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no.: 212,
A - Block,
2nd floor,
Department of Anesthesia,
SRM Medical College Hospital and Research Centre,
SRM Nagar,
Kattankullathur.
Chennai
TAMIL NADU
603203
India |
| Phone |
9790445445 |
| Fax |
|
| Email |
ts0480@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anand |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no.: 214,
A - Block,
2nd floor,
Department of Anesthesia,
SRM Medical College Hospital and Research Centre,
SRM Nagar,
Kattankullathur.
Chennai
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
anandk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Theyjes |
| Designation |
Post-Graduate |
| Affiliation |
SRM Medical College Hospital and Research Center |
| Address |
Room no.: 412,
A - Block,
2nd floor,
Department of Anesthesia,
SRM Medical College Hospital and Research Centre,
SRM Nagar,
Kattankullathur.
Chennai
TAMIL NADU
603203
India |
| Phone |
9790445445 |
| Fax |
|
| Email |
ts0480@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,
SRM nagar,
Chengalpattu district,
Tamil Nadu - 603203. |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Centre |
| Address |
SRM NAGAR,
Chengalpattu district,
Tamil nadu - 603203. |
| 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 Theyjes |
SRM Medical College Hospital and Research Centre |
SRM Institute of Science and Technology,
SRM Nagar,
Kattankullathur - 603203.
Kancheepuram
TAMIL NADU |
9790445445
ts0480@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and research centre-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J986||Disorders of diaphragm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients on NIV with RSBI less than 105 |
|
| ExclusionCriteria |
| Details |
Pregnancy
Obesity (BMI more than 35)
Age more than 65
GCS less than 8
Prophylactic or rescue use of NIV after extubation
Pre-existing diaphragm palsy
Skeletal deformity
Recent gastric surgeries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate specificity of HACOR scoring system and diaphragm ultrasound in predicting outcomes of NIV. |
6 hours from NIV |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate duration of NIV in ICU, To estimate mortality in ICU, To estimate percentage of patients requiring intubation |
18 months |
|
|
Target Sample Size
|
Total Sample Size="79"
Sample Size from India="79"
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
23/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Non-invasive Ventilation decreases the effort of inspiratory muscles and helps in oxygenation in patients with hypoxia due to acute respiratory failure. It is widely used to avoid intubation, and it’s failure requires tracheal intubation which further increases morbidity. Therefore, early identification of patients at risk for NIV failure and intubation can result in better outcome. The decision to wean patient from NIV is based on clinical and physiological parameters (RSBI - Rapid Shallow Breathing Index and HACOR - Heart rate, Acidosis, GCS, Oxygenation and Respiratory rate). However high failure rates and can lead to premature NIV termination. We have devised this study to compare the efficacy of HACOR scoring system with Diaphragm Ultrasound in predicting the outcomes of weaning from NIV. |