Critically IllNCT06705374
Central Venous Pressure and Right Atrial Pressure Measurements in Supine, Semi-recumbent and Trendelenburg Position
An observational study of Critically Ill, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients, in mechanical ventilation, sedated to RASS -4 or -5 in mechanical ventilation with a 4 or 5 line CVC.
Who may be able to join
- Critically ill patients in mechanical ventilation with an arterial line and a four or five lumen CVC.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41345
About this study
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).
Read the 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.
- Conditions
- Critically Ill
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 minutes after body position change
Secondary outcomes (10)
Change in hemodynamic parameters after body position change
Change in CVP (mmHg)
Measured: 3 minutes after body position change
Change in hemodynamic parameters after PEEP change
Change in RAP (mmHg)
Measured: 1 minutes after PEEP change
Change in hemodynamic parameters after body position change
Change in arterial pressure (mmHg)
Measured: 3 minutes after body position change
Change in hemodynamic parameters after body position change
Change in perfusion index (%)
Measured: 3 minutes after body position change
Change in hemodynamic parameters after body position change
Change in capillary refill time change (sek)
Measured: 3 minutes after body position change
Change in hemodynamic parameters after body position change
Change in RAP (mmHg)
Measured: 3 minutes after body position change
Change in hemodynamic parameters after PEEP change
Change in CVP (mmHg)
Measured: 1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
Change in arterial pressure (mmHg)
Measured: 1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
In capillary refill time change (sek)
Measured: 1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
Change in perfusion index (%)
Measured: 1 minutes after PEEP change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Nov 2023
- Primary completion15 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Carl Sjödin, Vastra Gotaland Region
- Investigators
- Lotta Johansson, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705374
- Sponsor's protocol ID
- CVP/RAP
- Status last verified
- May 2025
- First submitted
- 30 Apr 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All excel data that underlie results in publication
Publications
Sjodin C, Oras J, Johansson L, Persson P, Olausson S, Holmqvist J, Ille A, Vidovic N, Svensson CJ. Central Venous Pressure Referencing in the Lateral Position: Comparison With Direct Right Atrial Pressure in Mechanically Ventilated ICU Patients. Acta Anaesthesiol Scand. 2026 Jul;70(6):e70280. doi: 10.1111/aas.70280.
PubMed 42285730
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Pressure and Right Atrial Pressure Measurements in Supine, Semi-recumbent and Trendelenburg Position
- ClinicalTrials.gov ID
- NCT06705374
- Acronym / sponsor ID
- CVP/RAP
- Conditions
- Critically Ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients, in mechanical ventilation, sedated to RASS -4 or -5 in mechanical ventilation with a 4 or 5 line CVC.
Key inclusion criteria (1 listed)
- Critically ill patients in mechanical ventilation with an arterial line and a four or five lumen CVC.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
10 secondary outcomes
Change in hemodynamic parameters after body position change
Time frame: 3 minutes after body position change
Change in hemodynamic parameters after PEEP change
Time frame: 1 minutes after PEEP change
Change in hemodynamic parameters after body position change
Time frame: 3 minutes after body position change
Change in hemodynamic parameters after body position change
Time frame: 3 minutes after body position change
Change in hemodynamic parameters after body position change
Time frame: 3 minutes after body position change
Change in hemodynamic parameters after body position change
Time frame: 3 minutes after body position change
Change in hemodynamic parameters after PEEP change
Time frame: 1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
Time frame: 1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
Time frame: 1 minutes after PEEP change
Change in hemodynamic parameters after PEEP change
Time frame: 1 minutes after PEEP change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Derived from this study: PubMed 42285730Sjodin C, Oras J, Johansson L, Persson P, Olausson S, Holmqvist J, Ille A, Vidovic N, Svensson CJ. Central Venous Pressure Referencing in the Lateral Position: Comparison With Direct Right Atrial Pressure in Mechanically Ventilated ICU Patients. Acta Anaesthesiol Scand. 2026 Jul;70(6):e70280. doi: 10.1111/aas.70280.
- Individual participant dataSharing planned: Yes. All excel data that underlie results in publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lotta Johansson, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mmHg between Right atrial pressure (RAP) and Central venous pressure (CVP) in supine position (time frame: 3 minutes after body position change). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.