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

Not Applicable

Completed

• Conditions: Lung Transplantation

• Registration Number: NCT04891094
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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

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.

Study Timeline

• Study First Submitted: 2021-02-18
• Study Start: 2021-04-16
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-18
• Primary Completion: 2022-04-15
• Status Verified: 2022-05
• Study Completion: 2022-05-15
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• informed consent
• patient following lung transplantation

Exclusion Criteria

• no informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The value of LUS in diagnosing PGD	postoperative day 3	number of days with PGD in LUS versus standard of care
Is Lung Sliding reliable in the early postoperative course following lung transplantation?	postoperative day 3	Number of days with detectable lung sliding in LUS. Number of days with detectable pneumothorax in LUS.

Trial Locations

Locations (1)

Department of Anaesthesiology of the University Hospital of Munich; 🇩🇪 Munich, Germany