NCT04891094

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

February 18, 2021

Last Update Submit

May 30, 2022

Conditions

Lung Transplantation

Keywords

Lung ultrasoundLung transplantationprimary graft dysfunctionLung Sliding

Outcome Measures

Primary Outcomes (2)

  • The value of LUS in diagnosing PGD

    number of days with PGD in LUS versus standard of care

    postoperative day 3

  • 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

Interventions

UltrasoundDIAGNOSTIC_TEST

daily ultrasound of the lung and the diaphragm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • patient following lung transplantation

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Primary Graft Dysfunction

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Reperfusion InjuryVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 18, 2021

First Posted

May 18, 2021

Study Start

April 16, 2021

Primary Completion

April 15, 2022

Study Completion

May 15, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

DE(1)