RecruitingACTRN12618000685213

DCD 1010 (PILOT STUDY): Validation Of A Spontaneous Breathing Test To Better Predict Time To Circulatory Death In Organ Donation Candidates (Safety And Feasibility Study)


Sponsor

Dr Adelaide Charlton

Enrollment

70 participants

Start Date

Jan 13, 2018

Study Type

Interventional

Conditions

Summary

This study aims to establish a simple, safe, bedside test to better determine which patients are most suitable for organ donation following circulatory death. The DCD 10-10 test is a 10 minute spontaneous breathing trial which aims to determine respiratory drive in these patients, it is hypothesised that this test will be predictive of which patients will die within 90 minutes post withdrawal of cardiorespiratory support. This 90 minute time frame is essential for ensuring organ viability for donation. The DCD 10-10 Pilot Study is a safety and feasibility trial on a small sample of patients, it aims to ensure the DCD 10-10 test is safe and can be easily performed in the organ donation setting. It will also test software used for data collection and gather some early descriptive statistics on the sensitivity and specificity of the test and patient factors that correlate to time of death.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When a patient in intensive care has devastating brain injury and is not going to recover, their family may decide to withdraw life-sustaining treatment and allow a natural death — sometimes with the hope of donating organs to help others. This type of organ donation after circulatory death (DCD) requires the patient to stop breathing and the heart to stop within a specific time window (typically 90 minutes) to ensure the organs remain viable for transplantation. Currently, predicting which patients will die within that 90-minute window is difficult and inexact, which can mean some donation opportunities are missed. This pilot study is testing a simple 10-minute "spontaneous breathing test" — called the DCD 10-10 test — performed at the bedside to assess whether a patient still has any spontaneous breathing drive. Researchers believe this may help predict more accurately which patients are likely to die within the required timeframe. This study involves critically ill adults (18 and older) who are on mechanical ventilation, have a very low level of consciousness, and whose families have already consented to DCD organ donation. The test is being evaluated primarily for safety and feasibility in this sensitive and ethically important setting.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

A 10 minute spontaneous breathing trial will be performed to assess patient respiratory drive prior to cessation of cardiorespiratory support. This will involve transferring patients from the ventilat

A 10 minute spontaneous breathing trial will be performed to assess patient respiratory drive prior to cessation of cardiorespiratory support. This will involve transferring patients from the ventilator to a T-piece device. If breathing rate falls below 10 breaths per minute or oxygen saturations drop by 10% the patient will be reconnected to the ventilator and a positive test result recorded. Otherwise, they will be reconnected to the ventilator after a 10 minute observation period and a negative result recorded


Locations(10)

John Hunter Hospital - New Lambton

NSW,QLD,SA,VIC, Australia

Cairns Base Hospital - Cairns

NSW,QLD,SA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,SA,VIC, Australia

The Tweed Hospital - Tweed Heads

NSW,QLD,SA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,SA,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,QLD,SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,VIC, Australia

Flinders Medical Centre - Bedford Park

NSW,QLD,SA,VIC, Australia

Lyell McEwin Hospital - Elizabeth Vale

NSW,QLD,SA,VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW,QLD,SA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12618000685213