NCT06705374

Brief Summary

Intensive care is directed towards patients with severe illness or risk of serious outcomes following, for example, surgery. Central venous pressure (CVP) is an important part of the hemodynamic assessment of patients in surgery and the intensive care unit (ICU). CVP is normally measured via a central venous catheter (CVC) inserted through the subclavian or internal jugular vein, with the tip placed at the junction to the right atrium. A pressure tubing is connected to one of the branches of the CVC and then connected to a pressure sensor that sends a digital signal to the monitoring screen where CVP can be read in mmHg. To accurately read CVP, the pressure sensor must be positioned at the level of the right atrium. Different external reference points are used nationally and internationally to locate the correct height for the pressure sensor. This study aims to investigate the most commonly used external reference points for CVP measurement in various body positions compared to CVP measured via a solid state pressure catheter in the right atrium (RAP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

April 30, 2024

Last Update Submit

May 14, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Difference in mmHg between Right atrial pressure (RAP) and Central venous pressure (CVP) in supine position

    Difference in mmHg between RAP (Millar Micro-Cath) and CVP.

    3 minutes after body position change

  • Difference in mmHg between RAP and CVP in semi-recumbent position

    Difference in mmHg between RAP (Millar Micro-Cath) and CVP.

    3 minutes after body position change

  • Difference in mmHg between RAP and CVP in Trendelenburg position

    Difference in mmHg between RAP (Millar Micro-Cath) and CVP.

    3 minutes after body position change

  • Difference in mmHg between RAP and CVP in right lateral position

    Difference in mmHg between RAP (Millar Micro-Cath) and CVP.

    3 minutes after body position change

  • Difference in mmHg between RAP and CVP in left lateral position

    Difference in mmHg between RAP (Millar Micro-Cath) and CVP.

    3 minutes after body position change

Secondary Outcomes (10)

  • Change in hemodynamic parameters after body position change

    3 minutes after body position change

  • Change in hemodynamic parameters after PEEP change

    1 minutes after PEEP change

  • Change in hemodynamic parameters after body position change

    3 minutes after body position change

  • Change in hemodynamic parameters after body position change

    3 minutes after body position change

  • Change in hemodynamic parameters after body position change

    3 minutes after body position change

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients, in mechanical ventilation, sedated to RASS -4 or -5 in mechanical ventilation with a 4 or 5 line CVC.

You may qualify if:

  • Critically ill patients in mechanical ventilation with an arterial line and a four or five lumen CVC.

You may not qualify if:

  • under 18 years of age
  • in a dynamic phase of their illness i.e. ongoing treatment of severe circulatory or respiratory failure
  • positive end-expiratory pressure (PEEP) \>14 cmH20 or intolerance to change of body position.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lotta Johansson, MD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 30, 2024

First Posted

November 26, 2024

Study Start

November 15, 2023

Primary Completion

December 15, 2024

Study Completion

December 30, 2024

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All excel data that underlie results in publication

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations