| CTRI Number |
CTRI/2024/04/065225 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation between ultrasound findings and serum biomarkers in predicting weaning success for critically ill patients with abdominal trauma. |
|
Scientific Title of Study
|
Predictive value of diaphragmatic and lung ultrasound and it’s correlation with serum biomarker for weaning outcome in critically ill patients with abdominal trauma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sasank Sekhar Das |
| Designation |
Junior Resident |
| Affiliation |
|
| Address |
1st Floor,Department Of Anesthesiology,Indian Institute Of Medical Sciences,Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8400049201 |
| Fax |
|
| Email |
sasankdas988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjaree Mishra |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
1st Floor,Department Of Anesthesiology,Indian Institute Of Medical Sciences,Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452030626 |
| Fax |
|
| Email |
mnajari@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Manjaree Mishra |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
1st Floor,Department Of Anesthesiology,Indian Institute Of Medical Sciences,Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452030626 |
| Fax |
|
| Email |
mnajari@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department Of Anesthesiology,Indian Institute Of Medical Sciences,Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Department Of AnesthesiologyIndian Institute Of Medical SciencesBenaras Hindu University |
| Address |
1st Floor,Department Of Anesthesiology,Indian Institute Of Medical Sciences,Banaras Hindu University,
Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Institute Of Medical SciencesBenaras Hindu University |
1st Floor,Department Of Anesthesiology,Indian Institute Of Medical Sciences,Banaras Hindu University,
Varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sasank Sekhar Das |
Trauma Centre,Institute Of Medical Sciences,Banaras Hindu University |
Indian Institute Of Medical Sciences,Banaras Hindu University
Varanasi
UTTAR PRADESH |
8400049201
sasankdas988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS,BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S369||Injury of unspecified intra-abdominal organ, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18- 65 years, Sex both male and female, Isolated abdominal trauma patients requiring ICU admission, Respiratory failure requiring mechanical ventilation for more than 48 hrs. |
|
| ExclusionCriteria |
| Details |
Patient refusal, Ascites, Neuromuscular Disease, Neurological dysfunction, Lung pathology, Cervical trauma, Diaphragmatic dysfunction, Pregnancy, Heart failure, Obesity, Continuous infusion of muscle paralyzing agents for last 48 hrs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Prediction of weaning outcome by assessing diaphragmatic and lung ultrasound scores in critically ill patients with abdominal trauma.
2)Correlation of diaphragm and lung ultrasound scores with serum biomarkers for weaning outcomes in critically ill patients with abdominal trauma. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Length of ventilator stay
2)Length of ICU stay
3)Rate of Mortality |
4 week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/04/2024 |
| 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
|
Weaning from mechanical ventilation is a complex process that can be challenging in critically ill patients with abdominal trauma. The patients of abdominal trauma are often at risk for diaphragmatic dysfunction and lung injury, which can both impact their ability to breath independently. As a result, there is a high risk of weaning failure in this patient population. Diaphragmatic and lung ultrasound and biomarkers are emerging tools that can be used to assess a patient’s readiness for extubation. These techniques can provide real-time information about diaphragmatic function and lung aeration, which can be used to identify patients who are at risk for weaning failure. Through this study we hope to assess the predictive value of diaphragmatic ultrasound, lung ultrasound and biomarker levels for weaning from mechanical ventilation to reduce the mortality and improve the prognosis of the patients. |