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CompletedNCT04891094LUSUpdated Jun 1, 2022

Lung and Diaphragm Ultrasound in the Early Postoperative Course Following Lung Transplantation

An interventional study of Ultrasound in Lung Transplantation, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This feasibility study tries to define the value of daily Lung and Diaphragm Ultrasound in the early postoperative course following Lung transplantation by comparing its diagnostic accuracy with that of standard of care diagnostic procedures

Read the detailed description

Lung transplantation remains a high risk procedure. Common complications in the early postoperative course are, among others, primary graft dysfunction (PGD), hemorrhage, anastomosis insufficiency leading to pneumothorax, pneumonia, atelectasis and diaphragm dysfunction. Early diagnosis of complications is important to avoid further deterioration. Lung ultrasound (LUS) and diaphragm ultrasound (DUS) has a high diagnostic accuracy for identifying frequent conditions in the critically ill. Studies evaluating its value in patients following lung transplantation are missing. This study investigates the feasibility and clinical ability of LUS and DUS to identify common complications following lung transplantation and compares it to standard of care diagnostic procedures. The investigators start a prospective cohort study of lung transplant recipients who undergo lung transplantation at the university hospital Munich. Daily LUS and DUS in the early postoperative phase will be performed to detect and monitor complications. The US results will be compared to the results of diagnostic procedures of the clinical routine such as clinical examination, chest x ray, hemodynamic monitoring, expert opinion on PGD and laboratory parameters.

The hypothesis is that daily LUS and DUS following lung transplantation helps to diagnose complications early and with higher accuracy compared to the results of diagnostic procedures of the clinical routine.

02

Conditions studied

  • Lung Transplantation

Keywords

  • Lung ultrasound
  • Lung transplantation
  • primary graft dysfunction
  • Lung Sliding
03

In context

Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • informed consent
  • patient following lung transplantation

Exclusion criteria

Exclusion Criteria:

  • no informed consent
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Interventions

  • Diagnostic testUltrasound

    daily ultrasound of the lung and the diaphragm

06

What researchers measure

Primary outcomes

  1. The value of LUS in diagnosing PGD

    number of days with PGD in LUS versus standard of care

    Time frame: postoperative day 3

  2. Is Lung Sliding reliable in the early postoperative course following lung transplantation?

    Number of days with detectable lung sliding in LUS. Number of days with detectable pneumothorax in LUS.

    Time frame: postoperative day 3

07

Study locations

1 site
  • Department of Anaesthesiology of the University Hospital of Munich
    Munich, 81377, Germany
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04891094
Lead sponsor
Ludwig-Maximilians - University of Munich
Responsible party
Michael Zoller MD (Clinical Professor, Ludwig-Maximilians - University of Munich) — Principal investigator
First posted
May 18, 2021
Start date
Apr 16, 2021
Primary completion
Apr 15, 2022
Completion
May 15, 2022
Last update
Jun 1, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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