- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06705374
Central Venous Pressure and Right Atrial Pressure Measurements in Supine, Semi-recumbent and Trendelenburg Position
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Västra Götaland
-
Göteborg, Västra Götaland, Sweden, 41345
- Sahlgrenska University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: Lotta Johansson, MD, Sahlgrenska University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVP/RAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Critically Ill
-
Third Military Medical UniversityNot yet recruiting
-
Niveus Medical, Inc.Terminated
-
Mahidol UniversityNot yet recruiting
-
China Medical University HospitalRecruitingCritically Ill PatientsTaiwan
-
Hospital Sao DomingosCompletedCritically Ill PatientsBrazil
-
Ain Shams UniversityUnknownCritically-ill PatientsEgypt
-
Hôpital Edouard HerriotCompletedCritically Ill PatientsFrance
-
Johannes Gutenberg University MainzUnknown
-
Kaohsiung Veterans General Hospital.CompletedCritically Ill PatientsTaiwan
-
St. Antonius HospitalCompletedCritically Ill Patients