| CTRI Number |
CTRI/2023/07/054700 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
03/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between the baseline thigh muscle ultrasound with chest muscle (diaphragm) ultrasound to see for outcome in patients on ventilator |
|
Scientific Title of Study
|
Association of baseline Diaphragmatic thickness and Quadriceps muscle thickness with weaning of mechanically ventilated patients in a tertiary care center in Eastern India: 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 |
yuvaraj s |
| Designation |
drnb trainee |
| Affiliation |
tata main hospital |
| Address |
department of critical care medicine, tata main hospital, c road (west), northen town, bistupur,
jamshedpur, jharkhand-831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7845734574 |
| Fax |
|
| Email |
sweetyuvi003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sujeet ashok joshi |
| Designation |
consultant intensivist |
| Affiliation |
tata main hospital |
| Address |
department of critical care medicine, tata main hospital, c road (west), northen town, bistupur,
jamshedpur, jharkhand-831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7774098061 |
| Fax |
|
| Email |
sujeet.joshi@tatasteel.com |
|
Details of Contact Person
Public Query
|
| Name |
yuvaraj s |
| Designation |
drnb trainee |
| Affiliation |
tata main hospital |
| Address |
department of critical care medicine, tata main hospital, c road (west), northen town, bistupur,
jamshedpur, jharkhand-831001
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7845734574 |
| Fax |
|
| Email |
sweetyuvi003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of critical care medicine Tata Main Hospital,C Road (West), Northen Town, Bistupur,
JAMSHEDPUR, Jharkhand-831001 |
|
|
Primary Sponsor
|
| Name |
Tata Main Hospital |
| Address |
Tata Main Hospital, C Road (West), Northen Town, Bistupur,
JAMSHEDPUR, Jharkhand-831001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of critical care medicine TMH hospitals |
TMH Bistupur Jamshedpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr YUVARAJ S |
Tata Main Hospital |
CCU and HDU, Department of critical care medicine, TMH, Jamshedpur, Jharkhand
Purbi Singhbhum
JHARKHAND |
7845734574
sweetyuvi003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Main Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (3) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (4) ICD-10 Condition: K00-K95||Diseases of the digestive system, (5) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (6) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (7) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age 18 years and more of both sex needing mechanical ventilation on ICU admission for more than 48 hrs |
|
| ExclusionCriteria |
| Details |
Body mass index of less than 18.5 and more than or equal to 30
Known neuro-muscular diseases such as myopathy, neuropathy, severe head injury or stroke
H/o orthopedic surgery of the lower limb
Recent invasive mechanical ventilation for >48 hrs(within 6 months)
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the baseline quadriceps muscle thickness as a predictor for successful weaning from mechanical ventilation in critically ill adult patients
|
Day 1
Day of first spontaneous breathing trial (SBT)
Day of extubation
Day shifting to ward |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate the baseline quadriceps muscle thickness with
1. baseline diaphragmatic thickness as a good predictor in weaning success
2. whether combination of both can predict weaning success better rather than the individual parameters
3. diaphragmatic excursion on the day of first SBT for predicting outcome
4. Duration of mechanical ventilation
5. Length of ICU stay
6. SOFA & APACHE II scores on admission |
Day 1
Day of first spontaneous breathing trial
Day of extubation
Day shifting to ward |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
13/07/2023 |
| 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="0"
Months="6"
Days="0" |
|
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
|
This study is to find the association of baseline quadriceps muscle thickness and baseline diaphragm muscle thickness with that of the weaning and outcome in patients requiring mechanical ventilation. The association between baseline diaphragm muscle thickness with weaning is well established while limited evidence exists with that of the peripheral muscle. Patients on ICU admission after meeting the inclusion criteria, the baseline measurements of the above muscles will be made along with the SOFA, APACHE II, mNUTRIC scores and other basic parameters. Patients will be checked for readiness to wean every morning and once are ready to wean, the spontaneous breathing trial will be given. On the day of first spontaneous trial, diaphragmatic excursion, SOFA scores will be measured. Once the patient passes the spontaneous trial, they will be extubated. Reintubation or death will be considered as weaning failure. The duration of mechanical ventilation, length of stay, outcomes will be measured. This study thus will be helpful in predicting the outcomes of mechanically ventilated patients on the day of admission to ICU using the baseline muscle parameters. |