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Not yet recruitingNAINTERVENTIONAL

Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes

This study is a first step to see if a bigger study is possible. It's investigating if placing organ donors who are brain-dead on their stomach, rather than their back, can make their donated lungs healthier. Currently, there aren't enough donated lungs for everyone who needs a transplant, which is a life-saving treatment for serious lung disease. Researchers want to find ways to make more donated lungs suitable for transplant. By looking at how donor positioning might affect the lungs and later the transplant recipient, this study hopes to increase the number of successful lung donations and ultimately help more people receive the transplants they desperately need.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Lorenzo delSorbo
Enrolment target
40
Start
02 Jan 2025
Estimated completion
01 Aug 2026
Lung Transplant Failure

What is this study about?

You might be wondering what this study is all about. It's focused on improving the number of donated lungs available for people who need a lung transplant. A lung transplant is a major operation that can save the lives of people with very severe lung conditions, but there's a real shortage of suitable lungs available for donation in the UK.

This study is looking at organ donors who are brain-dead. When someone is brain-dead, it means their brain has completely stopped working, and they can't recover. However, their organs, like their lungs, can sometimes be donated to help others. The researchers want to see if changing the position of these donors – specifically, if they lie on their stomach (which doctors call 'prone position') instead of on their back – can help keep their lungs in better condition. The idea is that this might make more donated lungs healthy enough to be used for transplants.

This particular study is a smaller, initial step. It's trying to figure out if it's practical to do a much larger study in the future. The bigger study would then look more closely at whether this change in donor position really does improve the quality of the donated lungs and makes a difference for the people who receive those lungs in a transplant operation. Ultimately, the goal is to save more lives by making more donated lungs available.

Key takeaways

  • This study is about improving the number of lungs available for transplant.
  • It's looking at whether placing deceased organ donors on their stomach helps their lungs.
  • The eventual goal is to help more people receive life-saving lung transplants.
  • This is a first step to see if a larger study on this topic is possible.
  • It focuses on improving organ donation practices, not on patients directly receiving new treatments.

Who may be eligible?

To be considered for this study, the person donating organs must be aged 18 or older. They must also have been declared brain-dead and have given consent for organ donation. Their suitability for organ donation will also need to be confirmed by the Trillium Gift of Life Network.

There are certain situations where someone wouldn't be able to take part in this study. For example, if they have certain open wounds on their front, or if a doctor decides that lying on their stomach isn't safe for them. Similarly, if there's any absolute reason why their lungs couldn't be transplanted at all, they wouldn't be included.

Specific medical conditions that would prevent participation include certain serious infections like HIV, Hepatitis B, or active tuberculosis, or if they have had COVID-19 recently. Also, if they have had active cancer within the last five years (excluding some skin or brain cancers) or certain types of cancer even longer ago, they would not be eligible to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is the organ donor 18 years old or older?
  2. Has the organ donor been officially declared brain-dead?
  3. Has consent been given for organ donation?
  4. Does the organ donor have any significant front-facing wounds or conditions that make lying on their stomach unsafe?
  5. Does the organ donor have any serious infections like active HIV, Hepatitis B, or tuberculosis, or recent COVID-19?
  6. Does the organ donor have certain types of cancer treated in the last few years?
Answer every question to see your result.

What does participation involve?

This study is about donors and recipients, so individual patients will not directly 'take part' in the traditional sense of having appointments or medical interventions specifically for the study. Instead, the study focuses on how donated organs are handled. If a person becomes an organ donor after a neurological determination of death and meets the study criteria, data related to their care and their donated lungs would be included in the study. Similarly, if someone receives a lung transplant from such a donor, information about their outcome would be collected. There are no extra hospital visits, medications, or follow-up appointments for individuals as a direct result of this study. The total duration of data collection for each donor and recipient would span from the point of organ donation through a period after the transplant to assess outcomes.

Potential risks and benefits

There are no direct personal risks or benefits to individuals reading this information. The study is focused on improving organ donation practices, which may indirectly benefit society by increasing the availability of organs. For the organ donor, the prone positioning is a medical technique that is already sometimes used and would be carefully managed by medical staff. For transplant recipients, the potential benefit is improved lung function from the donated organ, leading to better outcomes. However, it's also possible that there is no difference or even unforeseen risks, which is why the study is being conducted. Any individual or family involved in organ donation always has the right to fully understand what is involved and to make choices based on their beliefs.

Locations (1)

  • Toronto General Hospital
    Verified postcode
    Toronto, Canada

Common questions

What does 'prone position' mean?

Prone position simply means lying down flat on your stomach.

What is 'neurologically deceased'?

This is another way of saying 'brain-dead'. It means a person's brain has permanently stopped working.

Why is this study needed?

There aren't enough donated lungs for everyone who needs a transplant, so researchers are looking for ways to make more donated lungs suitable for use.

Will this study affect my treatment if I need a lung transplant?

This study aims to improve the number and quality of donated lungs, which could indirectly lead to more available lungs for transplant patients in the future.

Is this study safe for organ donors?

The medical team would always ensure that any care provided to an organ donor is safe and appropriate, following strict medical guidelines.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Prone Positioning in Neurologically Deceased Potential Organ…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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