| CTRI Number |
CTRI/2022/10/046482 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of difference in thigh muscle thickness(Rectus femoris) over time in ICU with failure to successfully discontinue ventilatory support in Critically ill ventilated patients. |
|
Scientific Title of Study
|
Correlation of delta rectus femoris thickness with weaning failure in critically ill mechanically ventilated patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uma Deshpande |
| Designation |
Senior Resident |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Medical College |
| Address |
Bharati Vidyapeeth (Deemed to be University) medical college and Hospital Pune Satara Road, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7798573523 |
| Fax |
|
| Email |
umayur2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwanath Patil |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Medical College |
| Address |
Bharati Vidyapeeth (Deemed to be University) medical college and Hospital Pune Satara Road, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7743875088 |
| Fax |
|
| Email |
vishwanath629@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uma Deshpande |
| Designation |
Senior Resident |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Medical College |
| Address |
Bharati Vidyapeeth (Deemed to be University) medical college and Hospital Pune Satara Road, Pune-411043
MAHARASHTRA
411043
India |
| Phone |
7798573523 |
| Fax |
|
| Email |
umayur2022@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research center |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research center |
| Address |
Bharati Hospital and research center, Dhankawadi Pune Satara Road Pune 411043 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Uma Deshpande |
Bharati Hospital and Research Center |
2nd floor, Dept. of Critical Care medicine, Bharati Hospital and Research Centre, Katraj, Satara Road, Pune-411043
Pune
MAHARASHTRA |
7798573523
umayur2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Medical College, Pune Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
i. Age above 18 years.
ii. Patients requiring more than 24 hours of mechanical ventilation on admission or within 24 hours of admission.
|
|
| ExclusionCriteria |
| Details |
i. Patients with trauma to bilateral thighs for eg- degloving injuries, burns, fractures etc.
ii. Patients with known neuromuscular disorders, stroke, previously diagnosed critical illness neuropathy, unilateral or bilateral swelling in the legs.
iii. Patients with history of chronic organ failures, malignancy and pregnancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weaning Failure after first spontaneous breathing trial |
At baseline, within 24 hours of first spontaneous breathing trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To measure length of ICU stay, ventilator free days and 28-day mortality in all patients. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
Final Enrollment numbers achieved (Total)= "139"
Final Enrollment numbers achieved (India)="139" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2022 |
| Date of Study Completion (India) |
31/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are small studies suggesting a correlation between difference in skeletal muscle thickness (rectus femoris + vastus intermedius), diaphragmatic thickness and excursion with weaning failure. As measurement of diaphragmatic thickness and excursion is difficult we have planned to determine correlation between USG guided delta rectus femoris muscle thickness and weaning failure in critically ill mechanically ventilated patients. |