跳至主要内容
临床试验/CTRI/2025/06/088847
CTRI/2025/06/088847已完成不适用

Factors that matter in Predicting Early Extubation in Adult Living Donor Living Transplant: A Game changing Approach

Dr Amit Singhal1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2025年6月28日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
720
试验地点
1
主要终点
and Delayed extubation group

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • All patients 18 years and above who had had undergone elective Living Donor Liver Transplant.

排除标准

  • Patients with Hepatic encephalopathy
  • Simultaneous Liver and Kidney Transplant
  • Patients who underwent transplant for Acute Liver failure
  • Patients who underwent re-transplantation.

结局指标

主要结局

and Delayed extubation group

时间窗: Total length of stay

(DE).

时间窗: Total length of stay

3. To study the success rate

时间窗: Total length of stay

of early extubation at our

时间窗: Total length of stay

centre

时间窗: Total length of stay

1.Identify predictors of early

时间窗: Total length of stay

extubation based on

时间窗: Total length of stay

retrospective analysis.

时间窗: Total length of stay

2.Comparitive analysis of

时间窗: Total length of stay

various preoperative and

时间窗: Total length of stay

intraoperative parameters in

时间窗: Total length of stay

Early extubation group (EE)

时间窗: Total length of stay

次要结局

  • Defining a subgroup of patients who could be prospectively planned for Early extubation.(Intraoperative period)

研究者

发起方
Dr Amit Singhal
申办方类型
Other [Non funded study ]
责任方
Principal Investigator
主要研究者

Dr Amit Singhal

BLK MAX SuperspecialityHospital

研究点 (1)

Loading locations...

相似试验