| CTRI Number |
CTRI/2026/03/106021 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Determining role of muscle ultrasound in intubated patients on ventilators in predicting the weaning from ventilator and also association of M-nutric score with outcomes. |
|
Scientific Title of Study
|
Association of muscle ultrasound with weaning outcomes in mechanically ventilated critically ill patients : influence of high vs low mNUTRIC score. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSH RATHORE |
| Designation |
DrNB SENIOR RESIDENT |
| Affiliation |
Amrita institute of medical sciences, Faridabad |
| Address |
2nd floor micu, Department of anesthesia and critical care, Amrita hospital, Faridabad, Haryana
Faridabad
HARYANA
121002
India |
| Phone |
09015739443 |
| Fax |
|
| Email |
hrathore15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AAYUSH CHAWLA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Amrita institute of medical sciences, Faridabad |
| Address |
2nd floor micu, Department of anesthesia and critical care, Amrita institute of medical sciences and research centre, sector-88, Faridabad, Haryana, India
Pin code- 121002
Faridabad
HARYANA
121002
India |
| Phone |
9811766334 |
| Fax |
|
| Email |
aayushdoc12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARSH RATHORE |
| Designation |
DrNB SENIOR RESIDENT |
| Affiliation |
Amrita institute of medical sciences, Faridabad |
| Address |
2nd floor micu, Department of anesthesia and critical care, Amrita hospital, Faridabad, Haryana
Faridabad
HARYANA
121002
India |
| Phone |
09015739443 |
| Fax |
|
| Email |
hrathore15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita institute of medical sciences and research centre, sector-88, Faridabad, Haryana, India
Pin code- 121002 |
|
|
Primary Sponsor
|
| Name |
DR HARSH RATHORE |
| Address |
2nd floor micu, Department of anesthesia and critical care, Amrita institute of medical sciences and research centre, sector-88, Faridabad, Haryana, India
Pin code- 121002 |
| 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 HARSH RATHORE |
Amrita institute of medical sciences and research centre |
DEPARTMENT OF ANESTHESIA AND CRITICAL CARE MEDICINE, MEDICAL ICU, ROOM NO- 2101
Faridabad
HARYANA |
09015739443
hrathore15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic 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 |
1. Age more than 18 years
2. Patients requiring invasive mechanical ventilation within 24 hours of ICU admission
3. Expected duration of mechanical ventilation more than 48 hours (as assessed by the treating intensivist)
4. Ability to obtain informed consent from the patient or legally acceptable representative
|
|
| ExclusionCriteria |
| Details |
1. Patients with pre-existing neuromuscular disorders.
2. Patients with known diaphragmatic pathology (diaphragmatic paralysis, eventration, or prior phrenic nerve injury)
3. Patients with spinal cord injury at the cervical or high thoracic level
4. Patients with previous lower limb amputation or pathology preventing RFCSA measurement
5. Morbid obesity (BMI more than 40), limiting adequate ultrasound visualization
6. Presence of chest tubes, surgical dressings, or wounds preventing ultrasound probe placement
7. Patients with do-not-resuscitate (DNR) or comfort care status at ICU admission
8. Pregnancy
9. Patients who are readmitted to the ICU after previous enrolment in the study
10. Refusal of consent by patient or legally acceptable representative
11. Patients who are expected to be transferred to another facility within 5 days.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between serial muscle ultrasound measurements [diaphragm excursion (DE), diaphragm thickening fraction (DTF), and rectus femoris cross-sectional area (RFCSA)] and weaning outcomes in mechanically ventilated critically ill patients stratified by mNUTRIC score (high vs low). |
day 1 and 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the changes in muscle ultrasound parameters (DE, DTF, and RFCSA) on ICU admission (Day 1) and Day 5 between patients with high mNUTRIC score versus low mNUTRIC score.
|
28 days |
To evaluate the association between daily caloric and protein intake during the first 5 ICU days and the magnitude of change in diaphragmatic function (DE and DTF) and peripheral muscle mass (RFCSA).
|
28 days |
| To determine whether baseline or serial measurements of muscle ultrasound parameters independently predict weaning success after adjusting for illness severity scores (APACHE II/SOFA), mNUTRIC score, and baseline characteristics. |
28 days |
| To assess the association between muscle ultrasound findings and clinical outcomes, including 28-day mortality, ICU length of stay, and organ support requirements (vasopressors and renal replacement therapy). |
28 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/03/2026 |
| 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="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
study aims to investigate the predictive value of serial muscle ultrasound
measurements [diaphragm excursion (DE), diaphragm thickening fraction (DTF),
and rectus femoris cross-sectional area (RFCSA)] for weaning outcomes in
mechanically ventilated critically ill patients, and to determine whether the
mNUTRIC score (high vs low) influences the relationship between muscle
ultrasound findings and weaning success. |