Diaphragm InjuryDIASPORANCT03667027
Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
An observational study of Diaphragm Injury and Respiratory Failure, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Injury, Respiratory Failure, Mechanical Ventilation Complication
- What is being tested?
- Respiratory support
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute respiratory failure awaiting lung transplantation who are being bridged to lung transplantation either by mechanical ventilation or extracorporeal life support.
Who may be able to join
- Receiving a respiratory support modality as a bridge to lung transplantation
- Formally listed for transplantation
- Undergoing lung transplantation for either obstructive or restrictive lung disease
- Undergoing elective thoracic surgery without any prior history of chronic pulmonary parenchymal disease
Who cannot join
- Previously diagnosed with neuromuscular disorder
- Received invasive mechanical ventilation for >48 hours in the preceding four weeks
- Thoracic cage deformity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto
Jenna Wong, MSc, 4163404800 ext. 7613, jenna.wong@uhn.ca
About this study
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.
Read the detailed description
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.
- Being tested
- Respiratory support
- Keywords
- Diaphragm Dysfunction, Acute Respiratory Failure, Mechanical Ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory supportDevice
Mechanical ventilation or extracorporeal life support
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing LTx with respiratory failure (cases) | Patients are receiving a respiratory support modality (mechanical ventilation and/or extracorporeal life support) as a bridge to lung transplantation (LTx). Receives: Device: Respiratory support | |
| Patients undergoing LTx without prior respiratory support | Patients undergoing lung transplantation but do not require prior bridging respiratory support. | |
| Elective thoracic surgical patients | Patients undergoing elective thoracic surgery for planned lung or esophageal resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline diaphragm thickness and thickening fraction at 7 days after lung transplant
Secondary outcomes (2)
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
Measured: Assessed immediately after transplantation
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)
Measured: Assessed immediately before transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Apr 2019
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm InjuryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Ewan Goligher, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667027
- Sponsor's protocol ID
- 18-5660
- Acronym
- DIASPORA
- Status last verified
- Dec 2024
- First submitted
- 31 Aug 2018
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
- ClinicalTrials.gov ID
- NCT03667027
- Acronym / sponsor ID
- DIASPORA / 18-5660
- Keywords
- Diaphragm Dysfunction, Acute Respiratory Failure, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing LTx with respiratory failure (cases) | – | Device: Respiratory supportPatients are receiving a respiratory support modality (mechanical ventilation and/or extracorporeal life support) as a bridge to lung transplantation (LTx). |
| Patients undergoing LTx without prior respiratory support | – | –Patients undergoing lung transplantation but do not require prior bridging respiratory support. |
| Elective thoracic surgical patients | – | –Patients undergoing elective thoracic surgery for planned lung or esophageal resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute respiratory failure awaiting lung transplantation who are being bridged to lung transplantation either by mechanical ventilation or extracorporeal life support.
Key inclusion criteria (4 listed)
- Receiving a respiratory support modality as a bridge to lung transplantation
- Formally listed for transplantation
- Undergoing lung transplantation for either obstructive or restrictive lung disease
- Undergoing elective thoracic surgery without any prior history of chronic pulmonary parenchymal disease
Key exclusion criteria (3 listed)
- Previously diagnosed with neuromuscular disorder
- Received invasive mechanical ventilation for >48 hours in the preceding four weeks
- Thoracic cage deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory supportMechanical ventilation or extracorporeal life support | Device | Patients undergoing LTx with respiratory failure (cases) |
Primary outcome
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
2 secondary outcomes
Correlate changes in diaphragm thickness and histological features of diaphragm dysfunction
Time frame: Assessed immediately after transplantation
Biomarkers for diaphragm dysfunction
Time frame: Assessed immediately before transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ewan Goligher, MD, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Injury and Respiratory Failure, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rongyu (Cindy) Jin (416-340-4800 ext. 7613, rongyu.jin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.