| CTRI Number |
CTRI/2024/02/063304 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound assessment of respiratory muscles in ICU. |
|
Scientific Title of Study
|
Sonographic assessment of parasternal intercostal muscles and diaphragm during mechanical ventilation: 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 |
Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
Bangalore KARNATAKA 560074 India |
| Phone |
09513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
KARNATAKA 560074 India |
| Phone |
09513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
KARNATAKA 560074 India |
| Phone |
09513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical College and Hospital, Bangalore-560074 |
|
|
Primary Sponsor
|
| Name |
Nadia Rose |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore |
| 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 Nadia Rose |
Rajarajeswari Medical college and hospital. |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore Bangalore KARNATAKA |
9513454567
dr.nadia.rose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari medical college and hospital instituitional ethics committe |
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 |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients expected to be mechanically ventilated for more than 48 hours in the age group 18-75 years. |
|
| ExclusionCriteria |
| Details |
1) pregnancy
2)Pneumothorax
3)Tracheostomy
4)primary neuromuscular disease
5)Chest trauma, thoracic surgery,chest tube in situ
6) Dressing over measurement site.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess changes in diaphragm and parasternal intercostal muscle thickness in patients undergoing mechanical ventilation. |
Day 1 to extubation,death or discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the role of diaphragm and parasternal intercostals muscle indices in predicting successful extubation or extubation failure during weaning from mechanical ventilation. |
Day 1 to extubation |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
04/03/2024 |
| 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 Yet Recruiting |
| 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
|
After institutional ethics committee approval, informed written consent will be taken from legally responsible relatives of patients satisfying the inclusion criteria.
Diaphragm measurement- 1) Thickness- High frequency 6-13 MHz linear probe in 8th-10Th intercoastal space between midaxillary line and anteroaxillary line perpendicular to chest wall, measured in semi recumbent position in 20-400. In B mode, the diaphragm will be seen as a 3-layered structure.The diaphragmatic pleura and peritoneal membrane will be parallel echoic lines, with hypoechoic muscle layer in between. Image will be frozen at the end of expiration and inspiration and the mean of three measurements will be taken. Thickening fraction will be calculated . Parasternal intercostals muscle measurement: It will be measured using 10-15Mhz probe 3-5cmlaterally from sternum, sagittal plane between 2nd and 3rd rib.Image will be for measurement. It will be identified as a three-layered biconcave structure. It will be measured at craniocaudal midpoint between ribs. Thickening fraction will be calculated. Mean of three measurements will be taken for calculation. . For the sake of feasibility and convenience, ultrasound will be performed on the right parasternal intercostal muscle only. Successful weaning will be defined as the ability of the patient to tolerate spontaneous breathing for at least 48 h. Weaning failure will be defined as the requirement of non-invasive mechanical ventilation or re-intubation within 48 h of extubation.
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