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

NCT07330505 | Not Yet Recruiting

• 1 other identifier: 2024-06578-01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Mean deviation in transducer position for MAP and CVP

  Continuous deviation (mmHg) between the clinical transducer position and the blinded reference zero point. Continuous (mmHg).

  During the 8-hour continuous monitoring period following initiation of blinded reference monitoring

Secondary Outcomes (4)

• Frequency of clinically relevant deviations

  During the same 8-hour continuous monitoring period following initiation of blinded reference monitoring

• Association between deviations and treatment decisions

  During the 8-hour continuous monitoring period, with treatment decisions assessed within 5 minutes following detection of a deviation

• Differences in deviation magnitude and frequency across hospitals and ICU specialties.

  During the 8-hour continuous monitoring period following initiation of blinded reference monitoring

• Hemodynamic context of deviations

  At baseline and during the subsequent 8-hour continuous monitoring period

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult (≥18 years) critically ill, mechanically ventilated ICU patients receiving routine invasive arterial blood pressure and central venous pressure monitoring, often under sedation and vasoactive support.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Related Publications (1)

• 1. Cecconi, M., et al., Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med, 2014. 40(12): p. 1795-815. 2. Vincent, J.L., Critical care - where have we been and where are we going? New England Journal of Medicine, 2013. 369(19): p. 1839-1841. 3. Vincent, J.L. and D. De Backer, Circulatory shock. New England Journal of Medicine, 2013. 369(18): p. 1726-1734. 4. Giusti, G.D., Critical care nurses' perspectives on cardiac monitoring: barriers and training needs. BMC Nursing, 2024. 23: p. 742. 5. Alastalo, T.T., Critical care nurses' observational skills in detecting early patient deterioration. Intensive and Critical Care Nursing, 2017. 43: p. 97-103. 6. Magder, S., Right Atrial Pressure in the Critically Ill: How to Measure, What Is the Value, What Are the Limitations? Chest, 2017. 151(4): p. 908-916. 7. Sjödin, C., S. Sondergaard, and L. Johansson, Variability in alignment of central venous pressure transducer to physiologic reference point in the intensive care unit-A descriptive and correlational study. Aust Crit Care, 2019. 32(3): p. 213-217. 8. Figg, K.K. and E.C. Nemergut, Error in central venous pressure measurement. Anesth Analg, 2009. 108(4): p. 1209-11. 9. Oh, C., et al., Errors in pressure measurements due to changes in pressure transducer levels during adult cardiac surgery: a prospective observational study. BMC Anesthesiol, 2023. 23(1): p. 8. 10. Jacobs, K., et al., Accuracy of intra-arterial line transducer levelling practice in a general intensive care unit. Aust Crit Care, 2024. 37(1): p. 51-57.

  BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lotta Johansson, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Sjödin, PhD student

CONTACT

+46313421096; carl.sjodin@vgregion.se

Lotta Johansson, PhD

CONTACT

0708199664; lotta.k.johansson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: SD: 2028-01-01 ED: 2033-12-31
• Access Criteria: Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request. Requests must include a brief research proposal and a data management plan. Data will be shared under a data use agreement that prohibits re-identification of participants and limits use to the approved purpose.