NCT04488627

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 20, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

July 20, 2020

Last Update Submit

August 18, 2020

Conditions

Transthoracic Echocardiography

Outcome Measures

Primary Outcomes (1)

  • Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view

    Inferior caval vein measurements are key parameters for assessment of preload and fluid responsiveness

    During the intervention

Study Arms (1)

Critically ill patients

Critically ill patients hospitalised in the intensive care unit indicated to echocardiographic examination.

Diagnostic Test: Conventional transthoracic echocardiographic examination at the intensive care unit.

Interventions

Conventional transthoracic echocardiographic examination at the intensive care unit.DIAGNOSTIC_TEST

Conventional transthoracic echocardiographic examination at the intensive care unit targeted to inferior caval vein examination from different views.

Critically ill patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult intensive care unit patients on mechanical ventilation.

You may qualify if:

  • Inpatients
  • Patients on mechanical ventilation indicated for transthoracic echocardiographic examination

You may not qualify if:

  • Age \<18 years
  • Insufficient imaging quality
  • Refusal of echocardiographic examination by patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk Hospital Usti nad Labem

Ústí nad Labem, 40113, Czechia

RECRUITING

Study Officials

  • Roman Skulec, MD, PhD

    Masaryk Hospital Usti nad Labem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Skulec, MD, PhD

CONTACT

00420777577497skulec@email.cz

Barbora Pakostova, MD

CONTACT

00420720172670Barbora.Pakostova@kzcr.eu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 28, 2020

Study Start

July 27, 2020

Primary Completion

May 31, 2021

Study Completion

July 31, 2021

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)