CTRI

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CTRI Number

CTRI/2024/07/071418 [Registered on: 26/07/2024] Trial Registered Prospectively

Last Modified On:

25/07/2024

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Prospective Observational Study

Study Design

Other

Public Title of Study

An ultrasound-based prospective study on assessment of the thickness of two different muscle groups to evaluate nutritional risk in patients admitted to ICU.

Scientific Title of Study

Rectus abdominis and rectus femoris muscle thickness in determining nutritional risk 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	LOVELY
Designation	Senior Resident, Department of Anaesthesiology
Affiliation	AIIMS Patna
Address	C5B,Department of anaesthesiology, 5th floor, IPD complex, AIIMS Patna, Phulwari Sharif, Patna, BIHAR 801507, India Patna BIHAR 801507 India
Phone	8210760298
Fax
Email	iamdrlovelysingh@gmail.com

Details of Contact Person
Scientific Query

Name	Umesh kumar bhadani
Designation	HOD, department of Anaesthesiology, AIIMS Patna
Affiliation	AIIMS Patna
Address	C5B,Department of anaesthesiology, 5th floor, IPD complex, AIIMS Patna, Phulwari Sharif, Patna, BIHAR 801507, India Patna BIHAR 801507 India
Phone	8969169123
Fax
Email	umeshbhadani@gmail.com

Details of Contact Person
Public Query

Name	Umesh kumar bhadani
Designation	HOD, department of Anaesthesiology, AIIMS Patna
Affiliation	AIIMS Patna
Address	C5B,Department of anaesthesiology, 5th floor, IPD complex, AIIMS Patna, Phulwari Sharif, Patna, BIHAR 801507, India Patna BIHAR 801507 India
Phone	8969169123
Fax
Email	umeshbhadani@gmail.com

Source of Monetary or Material Support

Department of Anaesthesiology, B6B ICU, 6th Floor, IPD Block, AIIMS, Phulwari Sharif, Patna, Bihar PIN- 801507

Primary Sponsor

Name	AIIMS Patna
Address	Department of Anaesthesiology, B6B ICU, AIIMS Patna, Bihar 801507, India
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr LOVELY PDF Department of Anaesthesiology	All India Institute of Medical Sciences, Patna	6th floor ICU, B6B, Department of Anaesthesiology, All India Institute of Medical Sciences, Patna, Bihar, PIN- 801507 Patna BIHAR	8210760298 iamdrlovelysingh@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
The Institutional Ethics Committee, AIIMS, Patna	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J181\|\|Lobar pneumonia, unspecified organism,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	Patients of more than 18 years of age admitted in B6B ICU, AIIMS Patna

ExclusionCriteria

Details

Less than 18 years of age
Pregnant women
Patients who had undergone abdominal surgery
Patients with a known muscular disorder
BMI more than 35
Patients not providing consent

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

Rectus abdominis muscle (RAM) and rectus femoris muscle (RFM) thickness measured by ultrasonography will be recorded on both
sides for each patient. Sensitivity, Specificity, Positive and Negative predictive
values, and accuracy of RAM and RFM, Area under curve (AUC) will be calculated
mNUTRIC score will be calculated for each patient based on the five variables -
Age, APACHE II, SOFA, Number of comorbidities, and days from hospital to ICU
admission

After admission to the ICU, within the first 24 hours

Secondary Outcome

Outcome	TimePoints
Length of ICU stay is noted The need and duration of invasive mechanical ventilation is noted. Patient status (Alive/ Dead) is noted	Patients after admission to ICU will be followed till discharge or upto 28 days, whichever is earlier

Target Sample Size

Total Sample Size="145"
Sample Size from India="145"
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)

05/08/2024

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="0"
Months="7"
Days="4"

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

Nutritional status plays a pivotal role in the prognosis and recovery of critically ill patients. Several scoring systems and tools are used to determine nutritional risk. However, only a few of them are useful in critically ill patients. The modified Nutrition Risk in Critically Ill (mNUTRIC) scoring system is recommended for screening. Although it is not the gold standard but is the most widely accepted and studied standard scoring system. There is a paucity of Nutritional risk assessment tools and methods providing quantitative results specific to critically ill patients. we are conducting this study to find a quantitative and practical evaluation method by determining the correlation of ultrasonographic measurement of rectus abdominis and rectus femoris muscle thickness in critically ill patients in the ICU with mNUTRIC score.