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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Retransplantation

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
5 years
2

FEV1 (L)

Forced expiratory volume in one second measured in liters

Time frame
5 years
3

FEV1 (%)

percent of forced expiratory volume in one second measured in percent

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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