NCT04413695

Brief Summary

Liver transplant is now a standard treatment for end-stage liver disease patients. Pulmonary complications are common in the perioperative period and are associated with adverse outcomes. This includes atelectasis, pneumothorax, pleural effusion, pulmonary edema, and collapse. Risk factors for the same are extensive surgery, transfusion of blood products, fluid overload, hemodynamic instability, coagulation abnormalities, renal dysfunction, and reperfusion syndrome. CXR with clinical judgment plays a key role in diagnosing pulmonary complications. However diagnostic ability of CXR is limited and moreover it is associated with unnecessary radiation exposure. Recently, lung USG has come up as an easily available tool to detect peri-op pulmonary complications. The technique is very easy to perform, less time-consuming, and totally cost-effective. Moreover, it can be easily learned by clinicians with a standard level of ability to handle an ultrasound probe for abdominal scans. In the setting of geriatric and ICU patients, fragility and immobility have a strong impact on the quality of a chest radiograph. So, the routine application of lung USG in this setting may significantly improve the outcome. Multiple studies have suggested that Lung USG is superior to CXR in diagnosing these lung conditions. Hence, this study aims to compare the lung ultrasound with CXR in detecting perioperative pulmonary complications in patients undergoing live donor liver transplantation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2021

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

May 30, 2020

Last Update Submit

October 4, 2021

Conditions

Keywords

liver transplantlung ultrasoundchest x ray

Outcome Measures

Primary Outcomes (1)

  • Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray

    Comparison of day of appearance of pulmonary complications on ultrasound and chest Xray

    till post operative seventh day

Secondary Outcomes (2)

  • Incidence and types of postoperative pulmonary complications after live donor related liver transplant (LDLT)

    First post-operative seven days

  • Correlation of lung ultrasound score with clinically relevant perioperative pulmonary complications and length of icu stay

    First post-operative seven days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

End stage liver disease patients

You may qualify if:

  • Age 18 to 65yrs All end stage liver disease patients undergoing live donor liver transplantation

You may not qualify if:

  • Patients not giving consent for enrollment Any structural cardiac condition Dead donor liver transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaurav Sindwani

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Related Publications (6)

  • Feltracco P, Carollo C, Barbieri S, Pettenuzzo T, Ori C. Early respiratory complications after liver transplantation. World J Gastroenterol. 2013 Dec 28;19(48):9271-81. doi: 10.3748/wjg.v19.i48.9271.

    PMID: 24409054BACKGROUND
  • Ruchonnet-Metrailler I, Blanchon S, Luthold S, Wildhaber BE, Rimensberger PC, Barazzone-Argiroffo C, Mc Lin VA. Pulmonary complications after liver transplantation in children: risk factors and impact on early post-operative morbidity. Pediatr Transplant. 2018 Jul 17:e13243. doi: 10.1111/petr.13243. Online ahead of print.

    PMID: 30019517BACKGROUND
  • Tierney DM, Boland LL, Overgaard JD, Huelster JS, Jorgenson A, Normington JP, Melamed RR. Pulmonary ultrasound scoring system for intubated critically ill patients and its association with clinical metrics and mortality: A prospective cohort study. J Clin Ultrasound. 2018 Jan;46(1):14-22. doi: 10.1002/jcu.22526. Epub 2017 Oct 6.

    PMID: 28984373BACKGROUND
  • Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.

    PMID: 26298866BACKGROUND
  • Yin W, Zou T, Qin Y, Yang J, Li Y, Zeng X, Kang Y; Chinese Critical Ultrasound Study Group (CCUSG). Poor lung ultrasound score in shock patients admitted to the ICU is associated with worse outcome. BMC Pulm Med. 2019 Jan 3;19(1):1. doi: 10.1186/s12890-018-0755-9.

  • Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.

Study Officials

  • gaurav sindwani, md

    ilbs

    STUDY CHAIR

Central Study Contacts

gaurav sindwani, md

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 30, 2020

First Posted

June 4, 2020

Study Start

November 11, 2019

Primary Completion

September 25, 2021

Study Completion

September 25, 2021

Last Updated

October 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations