| CTRI Number |
CTRI/2024/07/071019 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Diaphramatic dysfunction caused by ventilators in Recipients and Donors scheduled for Living Donor Liver Transplantation
|
|
Scientific Title of Study
|
Ventilator Induced Diaphramatic Dysfunction in Recepients and Donors scheduled for Living Donor Liver Transplantation
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahithi Latha Ronanki |
| Designation |
Senior Resident |
| Affiliation |
Institute Of Liver And Biliary Sciences |
| Address |
Department Of Anaestheisa and Critical Care,Institute Of Liver and Biliary Sciences,Vasant Kunj,New Delhi,India
New Delhi
DELHI
110070
India |
| Phone |
6281714682 |
| Fax |
|
| Email |
dr.sahithironanki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak K Tempe |
| Designation |
Head of The Department,Anaestheisa and Critical Care |
| Affiliation |
Institute Of Liver And Biliary Sciences |
| Address |
Room Number 3338,Department Of Anaestheisa And Critical Care,Institute Of liver and Bilary Sciences,Vasant Kunj,New Delhi
New Delhi
DELHI
110070
India |
| Phone |
09718599401 |
| Fax |
|
| Email |
tempedeepak@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahithi Latha Ronanki |
| Designation |
Senior Resident |
| Affiliation |
Institute Of Liver And Biliary Sciences |
| Address |
Department Of Anaesthesia and Critical care,Institute Of Liver And Biliary Sciences,Vasant Kunj,New Delhi
New Delhi
DELHI
110070
India |
| Phone |
6281714682 |
| Fax |
|
| Email |
dr.sahithironanki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Liver and Biliary Sciences,Vasant Kunj,New Delhi,110070,India |
|
|
Primary Sponsor
|
| Name |
Institute Of Liver And Biliary Sciences Vasnt KunjNew Delhi |
| Address |
Institute Of Liver And BIliary Sciences,Pocket D1 ,Vasnt Kunj,New Delhi,India 110070 |
| 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 Sahithi Latha Ronanki |
Institute Of Liver And BIliary Sciences,Pocket D1 ,Vasant Kunj |
Seminar Room,Department Of Anaesthesia,Institute Of Liver And Biliary Sciences,Vasnt Kunj,New Delhi
New Delhi
DELHI |
6281714682
dr.sahithironanki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Institute Of Liver And Biliary Sciences Sector D1,Vasant kunj,New Delhi 110070 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J986||Disorders of diaphragm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with chronic liver disease |
|
| ExclusionCriteria |
| Details |
Pediatric patients
Patients with neuromuscular disorders
Previous major thoracic or abdominal surgery (both donors and
recipients)
Acute liver failure
Repeat transplantation and surgerY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the incidence of ventilator induced diaphragmatic
dysfunction in recipients and donors scheduled for living donor liver
transplantation |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the diaphragm function (Excursion and Thickening Fraction)
using Ultrasound in cirrhotic patients undergoing LDLT and compare it with
Healthy Donors.
• To study the prevalence of pre-existing Diaphragmatic Dysfunction in
recepients of living donor liver transplantation.
• The association of Ascites, Pleura Effusion, and Sarcopenia with
Diaphragmatic Dysfunction – Predictors of Diaphramatic dysfunction |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/08/2024 |
| 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
|
• Ventilator-induced diaphragmatic dysfunction is a condition that occurs with
the use of mechanical ventilation and is associated with adverse effects on the
structure and function of the diaphragm.
• The Dysfunction has been reported to occur even after ventilation for a
duration of as little as 18 hours. (N Engl J Med. 2008)
• Mechanical ventilation causes a significant decrease in diaphragmatic
contractile force as well as atrophy of diaphragm muscle fibres.
• Ventilator-induced diaphragmatic dysfunction can prolong weaning time and
may be associated with poor weaning outcomes, ICU and hospital mortality.
• Ventilator Induced Diaphragmatic Dysfunction may be exacerbated by the use
of neuromuscular blockers and steroids.
• Diaphragmatic ultrasonography at the bedside has been found to be safe and
simple to conduct, allowing for both morphologic and functional examination
of the muscle.
• There are various causes that contribute to diaphragmatic dysfunction in
Cirrhotics undergoing LDLT:
8
• Cirrhotics have an increase in intra-abdominal pressure as a result of ascites,
which can affect the diaphragm function.
• Sarcopenia in cirrhotics, has been shown to be an independent predictor for
longer need of mechanical ventilation implying the connection with
respiratory muscle sarcopenia. (Kou et al Plos 2017)
• Hepatic Hydrothorax or associated pleural Effusion can also contribute to
Dysfunction. (PLEASE-2) Study. Respirology. 2022)
• Diaphragmatic paralysis can be caused by the application of a
suprahepatic/caval clamp and the resulting crush injury to the phrenic nerve
during orthotopic liver transplantation |