| CTRI Number |
CTRI/2023/03/050310 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To use ultrasound guided measurement of thigh muscle thickness as a predictor of outcome in critically ill patients admitted to the ICU |
|
Scientific Title of Study
|
Ultrasound assessment of quadriceps muscle layer thickness as a predictor of outcome in critically ill patients admitted to the intensive care unit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sham Antony |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9567132112 |
| Fax |
|
| Email |
shamantony1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Talwar |
| Designation |
Professor and Head of Department |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Talwar |
| Designation |
Professor and Head of Department |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground floor, Main OT complex, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi |
|
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Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sham Antony |
Vardhman Mahavir medical college and Safdarjung hospital |
Intensive Care Units
New Delhi
DELHI |
9567132112
shamantony1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir medical college and Safdarjung hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (3) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (4) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (5) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (6) ICD-10 Condition: K00-K95||Diseases of the digestive system, (7) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients (age>18 years) admitted to the ICU.
Expected mechanical ventilation for atleast 48 hours. |
|
| ExclusionCriteria |
| Details |
Patients with known neuro-muscular diseases, such as myopathy, neuropathy, cerebrovascular accident.
Amputated lower limbs, orthopedic surgery of lower limb.
Prone position.
Pregnancy.
Patients transferred from another hospital after 48hours of admission in ICU.
Extubation <48 hours or length of hospital stay < 72 hours( due to death or discharge) |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correlate quadriceps muscle layer thickness using ultrasound with mortality in critically ill patients admitted to the Intensive Care
Unit |
Day 1, day 3 and day 7/ day of discharge, whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate quadriceps muscle layer thickness using ultrasound with:
1.Duration of mechanical ventilation
2.Length of ICU stay
3.Modified Nutrition Risk in the Critically ill (mNUTRIC) score
in critically ill patients admitted to the Intensice Care Unit.
|
Day 1, day 3 and day 7/ day of discharge, whichever is earlier. |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/03/2023 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Muscle wasting can lead to ICU acquired muscle weakness and is a common complication in critically ill patients with an estimated incidence of 46%. Skeletal muscle wasting or atrophy occurs due to various reasons including decrease in external loading and neural activation during immobilization in ICUs, increase in inflammatory cytokines as a result of critical illness and sepsis, reduced nutritional intake, duration of ICU stay, prolonged mechanical ventilation, hypervolemia and advanced age. Even in healthy individuals, muscle degeneration can start as early as 4 hours after immobilization. Measurement of quadriceps muscle layer thickness using USG has shown that critically ill patients on mechanical ventilation presented with muscle wasting and that a greater loss of muscle thickness is associated with worse patient outcomes. The aim of this study is to correlate quadriceps muscle layer thickness with outcome parameters in critically ill patients admitted to the ICU. The quadriceps muscle thickness will be quantified using a portable B-mode US device with a linear array probe(frequency of 6-12 MHz). All measurements will be performed in semi-recumbent position(30- 45degree) with knees extending and toes pointing to the ceiling. A line joining the anterior superior iliac spine and the upper part of the patella will be drawn. On this line, a point at the junction of the upper two- thirds and lower one third will be marked and gel will be applied to the transducer and skin at this point. The linear transducer will be held perpendicular to the measured line forming a 90 degree angle. Depth will be adjusted to obtain the image of the femur, and the screen image will be frozen. Quadriceps muscle layer thickness will be quantified with a marking on the screen between the distance from the upper margin of the femoral bone and the lower border of the superficial fascia of the rectus femoris muscle, including both the rectus femoris and vastus intermedius muscles. The landmark will be imaged twice and averaged across each leg which will be recorded on days1,3 and 7/ day of discharge, whichever is earlier. Quadriceps muscle layer thickness will be correlated with the following parameters 1. Demography - Age, Gender, Height, Ideal body weight. 2. BMI 3. Reason for ICU admission 4. Co-morbidities- Renal/ Cardiac/ Hepatic/ Diabetes Mellitus/ Hypertension/ COPD and others 5. APACHE II score 6. SOFA score 7. mNUTRIC score 8. Serum glucose, creatinine, urea, electrolytes, procalcitonin, lactate, bicarbonate and pH 9. ICU mortality 10. Duration of mechanical ventilation and Length of ICU stay 11. Treatment given (renal replacement therapy, insulin, vasoactive drugs, invasive mechanical ventilation, steroids, neuromuscular blockade and sedatives) in 7 days after admission 12. Percentage of calorie and protein debt from day 1 to day 7. |