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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07330505
Enrollment
60
Registered
2026-01-09
Start date
2026-02-01
Completion date
2027-05-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Haemodynamic Instability

Keywords

Invasive arterial blood pressure monitoring, Central venous pressure monitoring, Pressure transducer leveling, Pressure transducer positioning, Intensive care unit, Critically ill, Patient safety, Mean arterial pressure, Right atrial pressure

Brief 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.

Detailed description

This is a prospective, multicenter, blinded observational study evaluating the accuracy of invasive pressure transducer levelling for arterial pressure (mean arterial pressure, MAP) and central venous pressure (CVP) during routine intensive care. Adult mechanically ventilated ICU patients with an indwelling arterial catheter and central venous catheter receiving vasopressor therapy are observed without any protocol-mandated changes to standard clinical care. To quantify levelling deviations without influencing clinical behavior, a parallel reference measurement setup is connected to the existing monitoring system. Two fluid-filled reference lines are connected in parallel to the pressure dome used for invasive monitoring and secured to the chest wall at the fourth intercostal space at half of the anteroposterior thoracic diameter, one on each side of the chest. This configuration allows continuous estimation of vertical deviation (mmHg) between the clinical transducer position and a predefined physiological reference level. During lateral positioning, deviation is calculated using the midpoint between the two reference lines as the reference. Reference lines are covered with dressings to maintain blinding of clinical staff to the reference levels. Physiological waveforms and calculated deviations are recorded continuously for an 8-hour monitoring period for each participant. In parallel, treatment actions plausibly influenced by interpretation of MAP or CVP (including vasopressor titration, fluid administration or removal, and nursing interventions related to positioning or transducer handling) are documented with timestamps to allow temporal association analyses. Relevant contextual variables are collected to support interpretation of deviations and clinical responses. Data quality is ensured through predefined measurement procedures, continuous digital waveform acquisition, synchronization of reference and clinical signals, and post hoc review of signal integrity. Periods affected by technical artifacts or signal loss are flagged according to predefined criteria. Data segments that are missing, uninterpretable, or invalid due to technical failure are treated as missing and excluded from analyses, without imputation. The study is designed to quantify the magnitude and frequency of invasive pressure transducer misalignment during routine ICU care and to explore whether clinically relevant deviations are associated with contemporaneous treatment decisions, with the aim of informing patient safety and quality improvement initiatives.

Interventions

None listed

Sponsors

Vastra Gotaland Region
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * ICU admission * Mechanically ventilated * Arterial catheter for MAP * Central venous catheter for CVP * Ongoing vasopressor therapy

Exclusion criteria

* Severe hemodynamic or respiratory instability * Contraindications for lateral positioning * Expected survival \<24 hours

Design outcomes

Primary

MeasureTime frameDescription
Mean deviation in transducer position for MAP and CVPDuring the 8-hour continuous monitoring period following initiation of blinded reference monitoringContinuous deviation (mmHg) between the clinical transducer position and the blinded reference zero point. Continuous (mmHg).

Secondary

MeasureTime frameDescription
Frequency of clinically relevant deviationsDuring the same 8-hour continuous monitoring period following initiation of blinded reference monitoringProportion of monitoring time (%) with deviation \>2 mmHg (CVP) or \>5 mmHg (MAP). Percentage of total monitoring time.
Association between deviations and treatment decisionsDuring the 8-hour continuous monitoring period, with treatment decisions assessed within 5 minutes following detection of a deviationRelationship between deviation size and treatment decisions (vasopressor adjustments, fluid therapy, nursing interventions). Binary outcome (decision yes/no), regression analysis.
Differences in deviation magnitude and frequency across hospitals and ICU specialties.During the 8-hour continuous monitoring period following initiation of blinded reference monitoringDifferences in deviation magnitude and frequency across hospitals and ICU specialties. Continuous (mmHg), categorical (% above threshold).
Hemodynamic context of deviationsAt baseline and during the subsequent 8-hour continuous monitoring periodAssociation between deviation magnitude and concurrent patient status (SOFA, MAP, CVP, CO, SVR, temperature). Continuous and categorical variables.

Countries

Sweden

Contacts

CONTACTCarl Sjödin, PhD student
carl.sjodin@vgregion.se+46313421096
CONTACTLotta Johansson, PhD
lotta.k.johansson@vgregion.se0708199664
PRINCIPAL_INVESTIGATORLotta Johansson, PhD

Sahlgrenska University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026