| CTRI Number |
CTRI/2024/01/061647 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Muscle ultrasound for diagnosing ICU acquired muscle weakness |
|
Scientific Title of Study
|
The predictive value of peripheral muscle ultrasound in the diagnosis of ICU acquired weakness in critically ill patients; 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 |
Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
413, 4th floor, Department of Anaesthesiology and Intensive Care, BL Taneja Block, Maulana Azad Medical College, New Delhi
Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
413, 4th floor, Department of Anaesthesiology and Intensive Care, BL Taneja Block, Maulana Azad Medical College, New Delhi
Bahadur Shah Zafar Marg, New Delhi
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
413, 4th floor, Department of Anaesthesiology and Intensive Care, BL Taneja Block, Maulana Azad Medical College, New Delhi
Bahadur Shah Zafar Marg, New Delhi
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, JLN Marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College & associated Lok Nayak Hospital |
| Address |
Near Delhi gate, Bahadur Shah Zaffar Marg, New Delhi-110002 |
| 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 Sukhyanti Kerai |
Lok Nayak Hospital |
4th floor ICU, Department of Anaesthesiology and Intensive Care, Emergency block,JLN Marg, New Delhi-110002
Central
DELHI |
9968527122
drsukhi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Maulana Azad Medical College and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL (observational study) |
NIL (observational study) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Anticipated ICU stay of at least 7 days
-Sequential Organ Failure Assessment (SOFA) score≥ 8 at the time of enrollment
|
|
| ExclusionCriteria |
| Details |
1. Patients with any known neuro-muscular diseases, such as myopathy, multiple sclerosis, or paraplegia
2. Amputated lower limbs
3. Patients with surgery on lower limbs
4. Patients who have been transferred from another hospital after a stay of 48 hours
5. Presence of tracheostomy on admission
6. History of ICU admission for at least 7 days in the last 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Specificity and sensitivity of the change in RF muscle thickness for diagnosis of ICU acquired weakness |
0 day (ICU admission), 3rd day, 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Specificity and sensitivity of change in RF cross sectional area, echogenicity and pennation angle for diagnosis of ICU acquired muscle weakness |
0 day (ICU admission), 3rd day, 5th day |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
22/01/2024 |
| 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="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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsukhi25@gmail.com].
- For how long will this data be available start date provided 10-12-2025 and end date provided 03-07-2027?
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
|
In critically ill patients, ICU-acquired muscle weakness results from a combination of muscle and nerve pathology, and early identification of this entity is challenging. The diagnosis is commonly made based on clinical examination requiring the cooperation of the patient. In this study, we will enroll adult patients admitted to ICU on mechanical ventilation for at least 48 hours. The quadriceps muscle will be evaluated by an ultrasound machine and thickness, cross-sectional area, echogenicity, and pennation angle will be noted. The measurements will be taken at the time of ICU admission, 3rd day, and on the 5th day. On day 5, the ICU-acquired muscle weakness will be assessed using the Medical Research Council (MRC) sum scale. The diagnostic accuracy of ultrasound muscle parameters for ICU-acquired muscle weakness will be evaluated. |