- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04488627
Reliability of Ultrasound Examination of the Inferior Caval Vein
August 18, 2020 updated by: Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic
Reliability of Ultrasound Examination of the Inferior Caval Vein From Different Views in Critically Ill Patients on Artificial Lung Ventilation
The purpose of this study is to compare validity of examination and measurement of inferior caval vein from different views in critically ill patients on mechanical ventilation.
Study Overview
Status
Unknown
Conditions
Detailed Description
A maximal and minimal diameter of inferior caval vein will be measured by transthoracic echocardiography in critically ill patients on mechanical ventilation hospitalised in the intensive care unit from four different views:
- Subcostal view on the inferior caval vein in the long axis,
- subcostal view on the inferior caval vein in the short axis,
- right lateral view on the inferior caval vein in the long axis,
- right lateral view on the inferior caval vein in the short axis.
Comparison between the results of measurements in the subcostal view in the long axis and other views will be performed.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Usti nad Labem, Czechia, 40113
- Recruiting
- Masaryk Hospital Usti nad Labem
-
Contact:
- Roman Skulec, MD, PhD
- Phone Number: 00420777577497
- Email: skulec@email.cz
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult intensive care unit patients on mechanical ventilation.
Description
Inclusion Criteria:
- Inpatients
- Patients on mechanical ventilation indicated for transthoracic echocardiographic examination
Exclusion Criteria:
- Age <18 years
- Insufficient imaging quality
- Refusal of echocardiographic examination by patient
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Critically ill patients
Critically ill patients hospitalised in the intensive care unit indicated to echocardiographic examination.
|
Conventional transthoracic echocardiographic examination at the intensive care unit targeted to inferior caval vein examination from different views.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view
Time Frame: During the intervention
|
Inferior caval vein measurements are key parameters for assessment of preload and fluid responsiveness
|
During the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Roman Skulec, MD, PhD, Masaryk Hospital Usti nad Labem
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)
July 27, 2020
Primary Completion (Anticipated)
May 31, 2021
Study Completion (Anticipated)
July 31, 2021
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 26, 2020
First Posted (Actual)
July 28, 2020
Study Record Updates
Last Update Posted (Actual)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 284/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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