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ID
Source
Brief title
Health condition
cardiovascular diseases
Sponsors and support
Intervention
Outcome measures
Primary outcome
Investigation if surrogate parameters such as Pulse Arrival Time (PAT) can be used to track blood pressure changes.
Secondary outcome
Up to beat-to-beat tracking of blood pressure using initiated blood pressure surrogates in critical care patients in OR and ICU versus invasive blood pressure measurements.
Background summary
Patients who are scheduled for surgery or are admitted to the ICU are eligible to participate. This observational study will not change anything in relation to their care except for the addition of extra ECG, PPG and NIBP sensors all of which are routinely available (CE marked) and in use in the hospital.
The NIBP cuff inflations are performed at intervals as compatible with the workflow/care of the patient. ECG and PPG are continuously measurements and have no potential effect or interference with care. Data recording times depend on the duration of surgery and will be up to 24 hours on the ICU.
Monitoring for patient care will be performed as usual and data therefrom will be recorded in the EMR (EPIC) as per hospital standards. Potentially important events will be reported on the case report form.
Study objective
The primary hypothesis for this data collection study is that there are various surrogate physiological parameters for inferring blood pressure (BP), which can be more easily obtained than the direct BP measurement. An example of such surrogate physiological parameter is the Pulse Arrival Time (PAT). PAT is the time interval between the electrical activation of heart for blood pump until the arrival of the blood in one of the peripheral arterial location. This time interval is a function of BP, among others. Therefore, our hypothesis is that the information about BP can be inferred from the measurement of surrogate parameters like PAT.
Study design
7Oct2019 inclusion of first patient, Q1 2020 inclusion of all 40 patients, Q2 2020 analysis and end of study
Inclusion criteria
• Patients admitted to the ICU with arterial line as standard of care
• Patients who undergo surgery (OR) with an arterial line as standard of care
• Age >18
• Patients who give their consent for the investigation
Exclusion criteria
• Neuro-trauma
• Obesity (BMI>40)
• Pregnancy
• Delirium (diagnosed by hospital)
• Significant language barrier that prevents the patient from understanding the Informed Consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8179 |
| Other | MEC-U : W19.046 |