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Noninvasive Early Detection of Lung Allograft Dysfunction After Lung Transplantation With Multiple Breath Washout Test

NCT05586906 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-05-16

No results posted yet for this study

Summary

Chronic rejection, more commonly called bronchiolitis obliterans syndrome (BOS), is the leading cause of death beyond the first year post lung transplantation. The diagnosis of BOS is typically made by clinical, physiological, and radiographic parameters. Early detection would be desirable since it allows treatment modification to stop or delay the process. In the last few years there has been a growing interest in lung clearance index (LCI), a measure of lung physiology derived from multiple breath washout tests. LCI is derived from Multiple Breath Washout (MBW) tests. Early detection of BOS with LCI measurement will allow the investigators early recognition of this chronic rejection form and with early institution of the enhanced treatment survival will increase. All paticipants who underwent bilateral lung transplantation at Zurich University Hospital will be included. The measurement will be done 3 months after lung transplantation. Approximately 90 paticipants will be included. The follow-up will be 5 years. If the investigators could detect the development of BOS with this novel method before the clinical deterioration (fall in lung function) the investigators can start the available treatment options before irreversible damage occurs. This might increase overall survival in the study cohort.

Conditions

  • Chronic Rejection of Lung Transplant

Interventions

DEVICE

Multiple Breath Washout (MBW) tests

LCI measurements (EXHALYZER® D with Nitrogen Washout System, ECO Medics AG) will be performed every month during follow-up beginning 3 months after lung transplantation.

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Carolin Steinack, MD · University of Zurich

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-04-01
Completion
2027-01-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586906 on ClinicalTrials.gov