None listed
Conditions
Brief 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.
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 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 negati
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
Sponsors
Dr Adelaide Charlton
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients who meet the GIVE trigger and have consented for DCD organ donation will be eligible for inclusion in the trial. Therefore, inclusion criteria will include patients whom are mechanically ventilated, with a Glasgow Coma Scale Score < 5, in whom end of life conversations have taken place. Note: Patient’s receiving a high level of respiratory support (FiO2 > 60%, PEEP > 10) or haemodynamic support (combined vasopressor/ ionotrope requirement > 1microg/kg/min) will be eligible for enrolment in the study and will have all data collected, including Staff Specialist prediction of time to death. It will then be at the Staff Specialists discretion as to whether the DCD 10 – 10 test is necessary to perform.
Exclusion criteria
- Patients less than 18 years of age - Patients who are pregnant - Non-ventilated patients - Patients meeting the criterial for brain death - Patients screened by the organ donation team, but deemed to be inappropriate for DCD, or whereby the person responsible has not given consent for DCD to proceed - Inability to gain consent for study enrolment
Outcome results
None listed