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Transducer Levelling Errors in Everyday ICU Practice - A Multicentre Blinded Observational Study

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

Invasive pressure monitoring (arterial blood pressure via arterial catheter and central venous pressure via central venous catheter) is fundamental to clinical decision-making in intensive care. Treatment with vasopressors, fluids, and nursing interventions depends on accurate measurements. Because pressure transducers are hydrostatic, even small levelling errors can produce clinically relevant deviations (approximately 1 mmHg per 1.3 cm of vertical misplacement). Such errors may contribute to inappropriate therapy, for example under-recognition of hypotension, unnecessary vasopressor escalation, or missed venous congestion. This prospective, multicenter, blinded observational study will quantify transducer levelling deviations during routine ICU care and evaluate whether clinically relevant deviations are associated with treatment decisions. Adult mechanically ventilated ICU patients with an arterial catheter, a central venous catheter, and ongoing vasopressor therapy will be included at hospitals in Västra Götalandsregionen, Sweden. Two blinded reference lines/sensors will be placed at predefined physiological zero levels for MAP and CVP and connected in parallel to the patient monitoring system. Continuous deviation (mmHg) between the clinical transducer position and the blinded reference level will be recorded for 8 hours while clinical staff remain unaware of the reference setup. MAP/CVP-related treatment decisions (e.g., vasopressor adjustments, fluid therapy, and nursing interventions) will be recorded with timestamps. The study will provide real-world data on the magnitude and frequency of invasive pressure transducer misalignment in daily ICU practice and its potential relationship to patient management.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• ICU admission

• Mechanically ventilated

• Arterial catheter for MAP

• Central venous catheter for CVP

• Ongoing vasopressor therapy

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Skaraborgs Sjukhus
NOT_YET_RECRUITING
Skövde
Contact Information
Primary
Carl Sjödin, PhD student
carl.sjodin@vgregion.se
+46313421096
Backup
Lotta Johansson, PhD
lotta.k.johansson@vgregion.se
0708199664
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 60
Treatments
Invasive Pressure Monitoring Cohort
Mechanically ventilated adult ICU patients undergoing routine invasive arterial blood pressure and central venous pressure monitoring. Pressure transducer positioning and associated pressure deviations are observed using blinded reference sensors without altering clinical care.
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov