Closed-Loop Communication Clinical Trial
Official title:
Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study
Verified date | November 2019 |
Source | Erasme University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - ICU patients under norepinephrine administration and equipped with a advanced hemodynamic monitoring device Exclusion Criteria: - Subjects under 18 years of age - Subjects not requiring cardiac output monitoring or an arterial line - Subject with Atrial Fibrillation - Subjects who are pregnant |
Country | Name | City | State |
---|---|---|---|
Belgium | Erasme | Brussels | Anderlecht |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of case Time in target (MAP within 5 mmHg of the predetermined MAP target). | The primary outcome will be the percentage of case time in target | 48 hours post-admission in the intensive care | |
Secondary | Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target) | Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target) | 48 hours post-admission in the intensive care | |
Secondary | Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running. | Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running. | 48 hours post-admission in the intensive care | |
Secondary | Amount of vasopressors received | Amount of vasopressors received | 48 hours post-admission in the intensive care | |
Secondary | Number of vasopressor modifications over the treatment time | Number of vasopressor modifications (increase or decrease infusion rate) over the treatment time | 48 hours post-admission in the intensive care | |
Secondary | Limitations of the closed-loop system | Number of errors, malfunction of the system during the treatment time | 48 hours post-admission in the intensive care |
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