Clinical trial NCT06602089: Superiority of Finger-sensor Monitoring: a Prospective Observational Study
Official title: Superiority of Finger-sensor Over Oscillometric Arterial Pressure Monitoring in Patients Having Non-cardiac Surgery: the Prospective Observational PERCEPTION Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
Lead sponsor: University of Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥18 years scheduled for elective low- to moderate-risk non-cardiac surgery with general anesthesia in whom intraarterial arterial pressure monitoring is planned

Brief summary: This is an observational study investigating whether finger-sensor arterial pressure monitoring is superior to oscillometric arterial pressure monitoring in patients having non-cardiac surgery. Specifically, the investigators will test the hypothesis that the agreement between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements (mean arterial pressure, systolic arterial pressure, and diastolic arterial pressure) is better than the agreement between oscillometric mean arterial pressure measurements and intraarterial mean arterial pressure measurements in patients having low- to moderate-risk non-cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* ≥18 years
* scheduled for elective low- to moderate-risk non-cardiac surgery with general anesthesia
* planned intraarterial arterial pressure monitoring

Exclusion Criteria:

* systolic arterial pressure interarm differences \>20 mmHg
* heart rhythms other than sinus rhythm
* contraindications for finger-sensor arterial pressure monitoring (e.g., arteriovenous shunts, Raynaud's disease)
* pregnant patients.

Primary outcomes:
measure: Difference in the agreement between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements, and the agreement between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements
timeFrame: During surgery
Secondary outcomes:
measure: Classification of measurement differences between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance
timeFrame: During surgery
measure: Classification of measurement differences between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance
timeFrame: During surgery
measure: Ability of finger-sensor arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring
timeFrame: During surgery
measure: Ability of oscillometric arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring
timeFrame: During surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Alina Bergholz, MD
role: PRINCIPAL_INVESTIGATOR
References: