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CTRI Number  CTRI/2025/06/088847 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Early extubation in adult patients undergoing living donor liver transplant  
Scientific Title of Study   Factors that matter in Predicting Early Extubation in Adult Living Donor Living Transplant: A Game changing Approach 
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 Amit Singhal 
Designation  Director 
Affiliation  BLK MAX SuperspecialityHospital 
Address  Department of HPB and Liver Transplant Anaesthesia and Critical Care, BLK MAX Superspeciality Hospital, Pusa Road New Delhi

New Delhi
DELHI
110005
India 
Phone  9891873774  
Fax    
Email  drsinghalamit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nitin Shanker  
Designation  Senior Consultant  
Affiliation  BLK MAX Superspeciality Hospital  
Address  Department of HPB and Liver Transplant Anaesthesia and Critical Care, BLK MAX Superspeciality Hospital

New Delhi
DELHI
110005
India 
Phone  9560599966  
Fax    
Email  drnitshanker@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Shanker  
Designation  Senior Consultant  
Affiliation  BLK MAX Superspeciality Hospital  
Address  Department of HPB and Liver Transplant Anaesthesia and Critical Care, BLK MAX Superspeciality Hospital

New Delhi
DELHI
110005
India 
Phone  9560599966  
Fax    
Email  drnitshanker@gmail.com   
 
Source of Monetary or Material Support  
HPB and Liver Transplant Anaesthesia and Critical Care, BLK MAX Superspeciality Hospital, New Delhi- 110005 
 
Primary Sponsor  
Name  Dr Amit Singhal 
Address  HPB and Liver Transplant Anaesthesia and Critical Care, BLK MAX Superspeciality Hospital, New Delhi- 110005 
Type of Sponsor  Other [Non funded study ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Amit Singhal  BLK Max Superspeciality Hospital  Department of HPB and Liver Transplant Anaesthesia and critical care Second floor, Organ Transplant ICU
New Delhi
DELHI 
09891873774

drsinghalamit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE DEPARTMENT OF ACADEMIC AFFAIRS, RESEARCH & CONTINUING EDUCATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (2) ICD-10 Condition: K768||Other specified diseases of liver, (3) ICD-10 Condition: K766||Portal hypertension, (4) ICD-10 Condition: K743||Primary biliary cirrhosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients 18 years and above who had had undergone elective Living Donor Liver Transplant  
 
ExclusionCriteria 
Details  1. Patients with Hepatic encephalopathy
2. Simultaneous Liver and Kidney Transplant
3. Patients who underwent transplant for Acute Liver
failure
4. Patients who underwent re-transplantation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Identify predictors of early
extubation based on
retrospective analysis.
2.Comparitive analysis of
various preoperative and
intraoperative parameters in
Early extubation group (EE)
and Delayed extubation group
(DE).
3. To study the success rate
of early extubation at our
centre 
Total length of stay 
 
Secondary Outcome  
Outcome  TimePoints 
Defining a subgroup of patients who could be prospectively planned for Early extubation.  Intraoperative period 
 
Target Sample Size   Total Sample Size="720"
Sample Size from India="720" 
Final Enrollment numbers achieved (Total)= "610"
Final Enrollment numbers achieved (India)="610" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/06/2025 
Date of Study Completion (India) 10/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Living donor liver transplant has significantly evolved over the years from both the surgical perspective and in regards the anaesthetic management. The traditional belief of mechanically ventilating patients postoperatively has now seen a gradual shift in practice towards early extubation in select group of patients. Decades of experience along with noted benefits observed in Cardiac surgery literature, prompted this radical change.The advantages of early extubation is manifold and has largely improved patient care. It has led to decreased incidence of pulmonary complications.Also noteworthy is the benefit of reduced ICU and subsequent hospital stay which has subjected to better utilization of resources and decreased financial burden. It is also a vital entity of Enhanced recovery after surgery (ERAS) which is now advocated globally as a progressive measure in care of surgical patients.

Early extubation is gaining momentum yet there still exists much dilemma on the predictive parameters which justify a safe and early extubation.We at our centre in BLK Max Superspeciality Hospital have been practising early extubation in majority of our patients except those who require to be excluded owing to their preoperative medical condition and neurological status. We carried a retrospective data analysis of our adult patients who had undergone Living donor Liver Transplant and identified parameters both preoperatively and intraoperatively, which may have influenced early extubation. A comparitive analysis shall also be performed between the Early extubation group (EE) and delayed extubation group (DE).

Study Design: Restrospective study

Study Period: May 2021 to April 2023

Study Population: All elective adult Living donor Liver transplants

Inclusion criteria: All patients 18 years and above who had undergone elective Living Donor Liver Transplant

Exclusion criteria: Patients in Hepatic encephalopathy in immediate preoperative period

                                Simultaneous Liver and Kidney Transplant

                                Patients who underwent Liver Transplant for Acute Liver failure.

                                Patients who underwent re-transplantation

Primary objective: Identify predictors of early extubation based on retrospective analysis

- Comparative analysis of various preoperative and intraoperative parameters in Early extubation (EE) and Delayed extubation (DE) group

- To study the incidence of early extubation at our centre

- Compare the duration of stay in ICU group and total length of stay in both the groups.

Secondary objective: Defining a subgroup of patients who could be prospectively planned for Early fast tracking

Statistical Analysis: Graph pad PRISM would be used for analysis of data

Values would be represented as a mean ± standard deviation ( in case of continuous variables) and expressed as number and percentage ( in case of categorical values).

 P value of < 0.05 will be considered statistically significant.

Parameters to be assessed-

Demographic data and preoperative variables:

1. Age

2. Sex M/F

3. Body Mass Index (BMI)

4. MELD Na

5. Etiology of Liver disease

6. Comorbidities. 

Intraoperative variables:

1. Crystalloids

2. Blood products used (PRBC/Platelets/Cryoprecipitate and Fresh frozen Plasma).

3. Ascites

4. Pleural effusion

5. Blood loss

6. Urine output

7. GRWR

8. End of surgery lactate

9. Cold ischemia time

10. Warm ischemia time

11. Anhepatic time

12. End of surgery Noradrenaline dose

13. End of surgery Vasopressin dose

Post operative variables:

1. Early extubation

2. Delayed extubation

3. Duration of mechanical ventilation

4. Need for reintubation

5. Intensive care stay

6. Total length of hospital stay

 
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