Health TrialsbyHealthPanel

Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant

ConditionsDiaphragm InjuryRespiratory FailureMechanical Ventilation Complication
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

This study is designed to characterize the changes in diaphragm structure, function and biology during bridging to lung transplant by mechanical ventilation or extracorporeal life support.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Receiving a respiratory support modality as a bridge to lung transplantation

Formally listed for transplantation

Disqualifiers

Previously diagnosed with neuromuscular disorder

Received invasive mechanical ventilation for >48 hours in the preceding four weeks

Thoracic cage deformity

Trial population

Patients with acute respiratory failure awaiting lung transplantation who are being bridged to lung transplantation either by mechanical ventilation or extracorporeal life support.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Respiratory support

    Device

    Mechanical ventilation or extracorporeal life support

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Patients undergoing LTx with respiratory failure (cases)1 intervention
Group B: Patients undergoing LTx without prior respiratory support0 interventions
Group C: Elective thoracic surgical patients0 interventions

Trial outcomes

Primary outcomes

1

Difference in diaphragm thickness and thickening fraction in patients using MV and patients using ECLS

Diaphragm thickness and injury score will be tested for an interaction between the bridging modality (MV vs. ECLS) and the duration of exposure to the modality on the degree of diaphragm injury and atrophy

Time frame
Change from baseline diaphragm thickness and thickening fraction at 7 days after lung transplant

Secondary outcomes

1

Correlate changes in diaphragm thickness and histological features of diaphragm dysfunction

Histological features to be assessed are: myofibril cross-sectional area, muscle fiber type, presence of cellular infiltrates, myofiber necrosis and regeneration, autophagy and fibro-fatty infiltration

Time frame
Assessed immediately after transplantation
2

Biomarkers for diaphragm dysfunction

Biomarkers to be assessed are: skeletal troponin-I and markers of systemic inflammation (IL-1, IL-6, Tumor Necrosis Factor (TNF)-alpha)

Time frame
Assessed immediately before transplantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

The Hospital for Sick Children

Collaborator

Source ClinicalTrials.gov
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