| CTRI Number |
CTRI/2021/01/030617 [Registered on: 20/01/2021] Trial Registered Prospectively |
| Last Modified On: |
09/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Examination of respiratory muscle called diaphragm using ultrasound and studying its relation with nutrition of ICU patients |
|
Scientific Title of Study
|
Ultrasonographic assessment of diaphragmatic muscle thickness and diaphragmatic thickness fraction in intensive care unit (ICU) patients and evaluation of modified Nutritional Risk in Critically Ill (mNUTRIC) score as a risk factor- a prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratibha Todur |
| Designation |
Assistant Professor |
| Affiliation |
manipal Academy of Higher Education |
| Address |
Department of Respiratory Therapy, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095103671 |
| Fax |
|
| Email |
pratibha.todur@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Souvik Chaudhuri |
| Designation |
Assistant Professor |
| Affiliation |
manipal Academy of Higher Education |
| Address |
Department of Critical Care, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvikchaudhuri1207@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Souvik Chaudhuri |
| Designation |
Assistant Professor |
| Affiliation |
manipal Academy of Higher Education, manipal |
| Address |
Department of Critical care, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvikchaudhuri1207@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education and Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Respiratory Therapy Manipal Academy of Higher education Manipal |
| Address |
MCHP, MAHE, Manipal |
| 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 |
| Pratiba |
Department of Critical Care, Kasturba hospital, Manipal |
ICU, Department of critical care, Kasturba Hospital, Unit of MAHE, MAnipal
Udupi
KARNATAKA |
8095103671
pratibha.todur@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years admitted to critical care unit and on oxygen support with either invasive ventilation/Non- invasive ventilation ( NIV) / high flow nasal cannula (HFNC) /non rebreathing mask (NRBM) /venturi devices as deemed suitable by ICU consultant |
|
| ExclusionCriteria |
| Details |
1. Patients with known neurological disorders.
2. Patients with any form of myopathies.
3. Patients with chest trauma
4. Patients have any abdominal surgeries in the last 2 months.
5. Any patient with known phrenic nerve disorders
6. Post nerve blocks which can alter phrenic nerve function like interscalene or supraclavicular brachial plexus blocks.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of change of diaphragm muscle thickness and diaphragmatic thickness fraction (DTF) over time in the patients on various levels of respiratory support, and its association with mNUTRIC score. |
on day of admission, day three and day seven |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| worst P/F ratio, lung ultrasound scores (LUS), days of ventilation on face mask/venturi/NRBM/NIV/IMV, outcome of ICU stay. |
on day of admission, day 3 and day 7 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
26/01/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
On the day of admission to the
ICU, the mNUTRIC score will be calculated. The patients will be either on
oxygen therapy devices like face mask, venturi devices, non-rebreathing bag
mask (NRBM), non-invasive ventilation (NIV) or on invasive mechanical
ventilation (IMV). Diaphragm muscle thickness and diaphragmatic thickness
fraction (DTF) will be evaluated on the right hemi-diaphragm on day od
admission to ICU ie day 0, day 3, day 7 in ICU. Ultrasound imaging will be done
with B- mode ultrasound with linear transducer probes. With the patients being
30-degree head up as usually in the ICU, the linear transducer will be placed
perpendicularly on the right chest wall, between the anterior axillary and
mid-axillary lines, between 8-10 intercostal space, at the zone of apposition
between pleura and diaphragm. Measurements of diaphragm muscle thickness will
be done three times at end-expiration, and the mean value will be recorded.
Similarly DTF will be evaluated 3 times, and the mean value will be recorded.
Diaphragmatic Thickness
Fraction(DTF) = Thickness at end inspiration- Thickness at end expiration/
Thickness at end expiration
On the days 1,3,7 of ICU stay, lung ultrasound will be
done after ultrasonographic evaluation of both lungs, and scoring will be done
as under
Lung Ultrasound Scoring
|
Point for each lung ultrasound score
|
Degree of lung aeration
|
Pattern
|
|
0 point
|
Normal
|
A lines
|
|
1 point
|
Moderate loss of aeration
|
Well separated B lines
|
|
2 point
|
Severe loss of aeration
|
Coalescent B lines
|
|
3 point
|
Complete loss of aeration
|
Lung Consolidation
|
|