Diaphragm InjuryRADARNCT04103996
Incidence, Risk Factors and Outcomes of Diaphragm Dysfunction After Lung Transplantation
An observational study of Diaphragm Injury and Lung Transplant; Complications, Mechanical, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The study is designed to characterize the changes in diaphragm function after lung transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Injury, Lung Transplant; Complications, Mechanical, Respiratory Failure
- What is being tested?
- Ultrasound and Respiratory function measurements
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: We plan to enroll a total of 100 patients who were listed and will benefit from lung transplant
Who may be able to join
- Adult patients greater than 18 years of age
- Listed for lung transplantation
Who cannot join
- Known diagnosis of chronic neuromuscular disease
- Relisting for transplantation
- Bridging to lung transplantation with respiratory support
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed to characterize the changes in diaphragm function after lung transplantation.
Read the detailed description
Diaphragm dysfunction (DD) is a well-known complication after lung transplantation. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation post-transplant - they become too weak to breathe. However, little is known about the pre-transplant predictive factors associated with diaphragm dysfunction . We have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows us to observe changes in diaphragm muscle structure and function.
The goal of the study is to determine whether pre-transplant diaphragm thickness and function are associated with diaphragmatic dysfunction after lung transplantation. This will help us to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.
- Conditions
- Diaphragm Injury, Lung Transplant; Complications, Mechanical, Respiratory Failure, Mechanical Ventilation Complication
- Being tested
- Ultrasound, Respiratory function measurements
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Sonographic measurements (diaphragm, abdominal muscle, and quadriceps thickness) will be acquired when listed for lung transplantation. Sonographic measurements will be recorded on a daily basis for up to 1 week after transplantation (while the patient remains intubated).
Respiratory function measurementsDiagnostic test
Maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) will be acquired after listing for lung transplantation. After transplant, MIP will be recorded once patients are eligible for a trial of spontaneous breathing and weekly thereafter. MEP will also be recorded at ICU discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diaphragm dysfunction at the first spontaneous breathing trial and at ICU discharge after lung transplantation
Diaphragm ultrasound will be used to visualize diaphragm dysfunction (maximal thickening fraction <20%)
Measured: First spontaneous breathing trial, an average of 1 to 7 days
Secondary outcomes (1)
Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction
Diaphragm thickness and function documented on ultrasound will be assessed
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start10 Feb 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewan Goligher, MD, PhD, Principal investigator, UHN Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103996
- Sponsor's protocol ID
- 19-5894
- Acronym
- RADAR
- Status last verified
- Dec 2024
- First submitted
- 27 Aug 2019
- 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
- Incidence, Risk Factors and Outcomes of Diaphragm Dysfunction After Lung Transplantation
- ClinicalTrials.gov ID
- NCT04103996
- Acronym / sponsor ID
- RADAR / 19-5894
- Conditions
- Diaphragm Injury, Lung Transplant; Complications, Mechanical, Respiratory Failure, Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Sep 2019 (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.
The study is designed to characterize the changes in diaphragm function after lung transplantation.
Detailed description
Diaphragm dysfunction (DD) is a well-known complication after lung transplantation. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation post-transplant - they become too weak to breathe. However, little is known about the pre-transplant predictive factors associated with diaphragm dysfunction . We have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows us to observe changes in diaphragm muscle structure and function.
The goal of the study is to determine whether pre-transplant diaphragm thickness and function are associated with diaphragmatic dysfunction after lung transplantation. This will help us to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to enroll a total of 100 patients who were listed and will benefit from lung transplant
Key inclusion criteria (2 listed)
- Adult patients greater than 18 years of age
- Listed for lung transplantation
Key exclusion criteria (3 listed)
- Known diagnosis of chronic neuromuscular disease
- Relisting for transplantation
- Bridging to lung transplantation with respiratory support
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 |
|---|---|---|
| UltrasoundSonographic measurements (diaphragm, abdominal muscle, and quadriceps thickness) will be acquired when listed for lung transplantation. Sonographic measurements will be recorded on a daily basis for up to 1 week after transplantation (while the patient remains intubated). | Diagnostic test | – |
| Respiratory function measurementsMaximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) will be acquired after listing for lung transplantation. After transplant, MIP will be recorded once patients are eligible for a trial of spontaneous breathing and weekly thereafter. MEP will also be recorded at ICU discharge. | Diagnostic test | – |
Primary outcome
Incidence of diaphragm dysfunction at the first spontaneous breathing trial and at ICU discharge after lung transplantation
Time frame: First spontaneous breathing trial, an average of 1 to 7 days
Diaphragm ultrasound will be used to visualize diaphragm dysfunction (maximal thickening fraction <20%)
1 secondary outcome
Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
Ewan Goligher, MD, PhD principal investigator
UHN 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 Lung Transplant; Complications, Mechanical, 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 2 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diaphragm dysfunction at the first spontaneous breathing trial and at ICU discharge after lung transplantation (time frame: First spontaneous breathing trial, an average of 1 to 7 days). 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.