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NCT04891094 Clinical Trial

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

Lung Transplantation Clinical Trial

— LUS  

Official title:
Lung and Diaphragm Ultrasound in the Early Postoperative Course Following Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04891094
Other study ID # LMU 283-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 16, 2021
Est. completion date May 15, 2022

Study information
Verified date May 2022
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date May 15, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - informed consent - patient following lung transplantation Exclusion Criteria: - no informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ultrasound
daily ultrasound of the lung and the diaphragm

Locations
Country Name City State
Germany Department of Anaesthesiology of the University Hospital of Munich Munich

Sponsors (1)
Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary The value of LUS in diagnosing PGD number of days with PGD in LUS versus standard of care postoperative day 3
Primary 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. postoperative day 3
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