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

NCT05586906 | Recruiting

• 1 other identifier: 2017-01610
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Lung Clearance Index (LCI) derived from Multiple Breath Washout Test (MBWT)

  LCI 2.5 (ext): lung clearance index at normalised end tidal concentration of N2 2.5% extrapolated

  5 years

• FEV1 (L)

  Forced expiratory volume in one second measured in liters

  5 years

• FEV1 (%)

  percent of forced expiratory volume in one second measured in percent

  5 years

Interventions

Multiple Breath Washout (MBW) tests DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All recipients who underwent bilateral lung transplantation at Zurich University Hospital will be included.

You may not qualify if:

• Retransplantation

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Study Officials

• Carolin Steinack, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolin Steinack, MD

CONTACT

0041442551111; carolin.steinack@usz.ch

Mace Schuurmans, MD

CONTACT

0041442551111; mace.schuurmans@usz.ch

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: Prof. Dr.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: October 19, 2022
• Study Start: March 1, 2023
• Primary Completion: April 1, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

CH (1)