Central Venous Pressure and Right Atrial Pressure Measurements in Supine, Semi-recumbent and Trendelenburg Position

May 14, 2025 updated by: Carl Sjödin, Vastra Gotaland Region
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

A Millar Mikro-Cath solid state pressure catheter is inserted through one of the medial lines of the CVC and guided in position by the pressure curve and verified in position by ultrasound.

CVP is compared to RAP in supine, semi-recumbent, Trendelenburg and lateral position.

CVP, RAP and arterial pressure is recorded in each session with Biopac Acqnowledge.

In each body position PEEP is raised 5 cmH20 and then lowered 5 cmH20.

Ventilator settings, capillary refill time, perfusion index are collected in each setting and before and after PEEP adjustments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Västra Götaland
      • Göteborg, Västra Götaland, Sweden, 41345
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in mmHg between Right atrial pressure (RAP) and Central venous pressure (CVP) in supine position
Time Frame: 3 minutes after body position change
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
Time Frame: 3 minutes after body position change
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
Time Frame: 3 minutes after body position change
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
Time Frame: 3 minutes after body position change
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
Time Frame: 3 minutes after body position change
Difference in mmHg between RAP (Millar Micro-Cath) and CVP.
3 minutes after body position change

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in hemodynamic parameters after body position change
Time Frame: 3 minutes after body position change
Change in CVP (mmHg)
3 minutes after body position change
Change in hemodynamic parameters after PEEP change
Time Frame: 1 minutes after PEEP change
Change in RAP (mmHg)
1 minutes after PEEP change
Change in hemodynamic parameters after body position change
Time Frame: 3 minutes after body position change
Change in arterial pressure (mmHg)
3 minutes after body position change
Change in hemodynamic parameters after body position change
Time Frame: 3 minutes after body position change
Change in perfusion index (%)
3 minutes after body position change
Change in hemodynamic parameters after body position change
Time Frame: 3 minutes after body position change
Change in capillary refill time change (sek)
3 minutes after body position change
Change in hemodynamic parameters after body position change
Time Frame: 3 minutes after body position change
Change in RAP (mmHg)
3 minutes after body position change
Change in hemodynamic parameters after PEEP change
Time Frame: 1 minutes after PEEP change
Change in CVP (mmHg)
1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
Time Frame: 1 minutes after PEEP change
Change in arterial pressure (mmHg)
1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
Time Frame: 1 minutes after PEEP change
In capillary refill time change (sek)
1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
Time Frame: 1 minutes after PEEP change
Change in perfusion index (%)
1 minutes after PEEP change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lotta Johansson, MD, Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVP/RAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All excel data that underlie results in publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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