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NCT Number: NCT03667027

Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto General Hospital

Toronto, Canada

Location status: Recruiting

Location contact

Jenna Wong, MSc

CONTACT

[email protected]

4163404800 ext. 7613

About this study

Mechanical ventilation has been linked to diaphragm injury and dysfunction. During mechanical ventilation, the amount of breathing work done by the diaphragm is unpredictable: the diaphragm could be completely rested, or it could be overworked. Either of these possibilities may cause injury to the diaphragm. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation - they become too weak to breathe. However, little is known about the relationship between changes in the diaphragm and the histological (structure of cells and tissue) basis of these changes. The investigators have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows them to observe changes in diaphragm muscle structure and function.

The goal of the study is to determine whether different forms of respiratory support (mechanical ventilation vs extracorporeal life support) lead to different degrees of diaphragm injury and to compare changes in the diaphragm seen on ultrasound to changes in the diaphragm tissues under a microscope. This will help the investigators to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Cases):

  • Receiving a respiratory support modality as a bridge to lung transplantation
  • Formally listed for transplantation

Inclusion criteria

(Control Group 1):

  • Undergoing lung transplantation for either obstructive or restrictive lung disease

Inclusion criteria

(Control Group 2):

  • Undergoing elective thoracic surgery without any prior history of chronic pulmonary parenchymal disease

Exclusion criteria

(Cases and Controls):

  • Previously diagnosed with neuromuscular disorder
  • Received invasive mechanical ventilation for >48 hours in the preceding four weeks
  • Thoracic cage deformity

Treatment and study plan

respiratory support

Device

Mechanical ventilation or extracorporeal life support

Primary outcomes

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

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

    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

Secondary outcomes

  1. Correlate changes in diaphragm thickness and histological features of diaphragm dysfunction

    Time frame: Assessed immediately after transplantation

    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

  2. Biomarkers for diaphragm dysfunction

    Time frame: Assessed immediately before transplantation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rongyu (Cindy) Jin

CONTACT

[email protected]

416-340-4800 ext. 7613

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Acronym: DIASPORA

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2018
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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