| CTRI Number |
CTRI/2024/02/063207 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound assessment of factors associated with difficulty in removal of breathing machine in patients with liver disease. |
|
Scientific Title of Study
|
Determination of factors associated with diaphragmatic weakness,abdominal expiratory muscle thickness and expiratory muscle thickness fraction in patients with simple, difficult and prolonged weaning patterns in the chronic liver disease - a prospective 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 |
Vedaghosh Amara |
| Designation |
Consultant Critical Care Medicine |
| Affiliation |
AIG Hospitals,Gachibowli |
| Address |
Department of Critical Care,3rd floor,Main block,Mindspace road,Gachibowli.
Hyderabad
Hyderabad
TELANGANA
5000032
India |
| Phone |
9985087798 |
| Fax |
|
| Email |
vedaghosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vedaghosh Amara |
| Designation |
Consultant Critical Care Medicine |
| Affiliation |
AIG Hospitals,Gachibowli |
| Address |
Department of Critical Care,3rd floor,Main block,Mindspace road,Gachibowli.
Hyderabad
Hyderabad
TELANGANA
5000032
India |
| Phone |
9985087798 |
| Fax |
|
| Email |
vedaghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vedaghosh Amara |
| Designation |
Consultant Critical Care Medicine |
| Affiliation |
AIG Hospitals,Gachibowli |
| Address |
Department of Critical Care,3rd floor,Main block,Mindspace road,Gachibowli.
Hyderabad
Hyderabad
TELANGANA
5000032
India |
| Phone |
9985087798 |
| Fax |
|
| Email |
vedaghosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIG Hospitals,Mindspace road,Gachibowli,Hyderabad,Telangana-500032 |
|
|
Primary Sponsor
|
| Name |
Vedaghosh Amara |
| Address |
Aig Hospitals,Mindspace road,Gachibowli,Hyderabad,Telangana-5000032. |
| 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 Vedaghosh Amara |
AIG hospitals |
Department of Critical Care,ICU 2,ICU 3,ICU 5,Third and Fourth floor,Main Road,Mindspace Road,Gachibowli
Hyderabad
TELANGANA |
9985087798
vedaghosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Asian Institute of Gastroenterology(IEC-AIG) |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult chronic liver disease patients aged 18-80 years.Patients undergoing spontaneous breathing trial (SBT) for the first time.
|
|
| ExclusionCriteria |
| Details |
1.patients less than 18 years
2.patients with chest and abdominal trauma,distorted abdominal wall anatomy
3.patients with damage to the abdominal wall. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Diaphragmatic excursion-normal or low
Diaphragmatic thickness fraction-normal or poor
Thickness of abdominal expiratory muscles-rectus abdominus(RA), Internal Oblique(IO),External Oblique(IO),Transverse Abdominus(TA).
Thickness pattern of abdominal expiratory muscles.
Days of mechanical ventilation
Length of ICU stay.
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome of ICU stay(Death),Length of icu stay,Days on mechanical ventilation,Presence of multidrug resistant infections. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/03/2024 |
| 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 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
|
The
health burden of liver cirrhosis has significantly increased worldwide.Acute respiratory failure
that requires mechanical ventilation is a major indication for the requirement
of ICU admission for cirrhotic patients. Both delayed and accelerated weaning
from the mechanical ventilation impose serious consequences on the patient
outcomes.Expiratory muscles are an important component of respiratory function and muscle pump, especially in critically ill patients. But, it is often neglected by the clinician, who focuses mostly on the inspiratory muscles like diaphragm. The expiratory muscle which are crucial for successful weaning from ventilatory support are rectus abdominis, internal oblique, external oblique and transverse abdominis muscles. The thickness of these muscles should follow a particular order for us to ensure that expiratory muscles are functioning properly. The order of thickness is rectus abdominis>internal oblique>external oblique>transverse abdominis. We aim to analyze this muscle thickness pattern using bedside ultrasound in ICU patients whenever they are being weaned from either non-invasive ventilation or invasive ventilation. So, we will be performing the bedside ultrasound on those weaning days, and we will record the expiratory muscle thickness order , lung ultrasound findings and even the inspiratory muscle (diaphragmatic) excursion. We will correlate these findings to assess whether this has a positive predictive value in spontaneous breathing success. If a correlation is found, the expiratory muscle ultrasound can form a part of future weaning protocols and criteria. We are prospectively going to recruit 80 patients with the given inclusion and exclusion criteria for the study over a period of one year |