NCT04173741

Brief Summary

Intravascular volume assesment is important for the management of the patients in the intensive care unit. Respiratory variation ratio of the inferior vena cava (IVC) can be determined by ultrasonography (USG) and is a useful tool for hemodynamic evaluation of the patient. Aim of this study is to search for correlation between respiratory variation ratios of the internal jugular vein (IJV) and the IVC before and after passive leg raise. Another aim of this study is to search for variability between ultrasonographic measurements of different doctors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 5, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 31, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

November 16, 2019

Results QC Date

August 6, 2020

Last Update Submit

August 20, 2020

Conditions

Keywords

Positive Pressure VentilationFluid ResponsivenessPassive Leg RaiseInferior Vena CavaInternal Jugular VeinInterobserver VariabilityUltrasound

Outcome Measures

Primary Outcomes (1)

  • Ultrasonography (USG) Measurements

    Because of the medium-high interrater correlation between USG measurements of the physicians, statistical analysis were done with the mean of USG measurements of 3 doctors.

    through study completion, 3 days

Study Arms (2)

Leg Rise Position - 3 Minutes

Patients who stayed in passive leg rise position for 3 minutes

Other: USG measurement

Leg Rise Position - 1 Minute

Patients who stayed in passive leg rise position for 1 minute

Other: USG measurement

Interventions

IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.

Leg Rise Position - 1 MinuteLeg Rise Position - 3 Minutes

Eligibility Criteria

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

Mechanically ventilated patients in the intensive care unit over 18 years of age

You may qualify if:

  • Mechanically ventilated
  • Over 18 years of age

You may not qualify if:

  • Infection in the site of measurement areas
  • Surgical sutures in the site of measurement areas
  • Intraabdominal hypertension
  • Severe aortic regurgitation
  • Lower extremity amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Hospital Anesthesiology Intensive Care Unit

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Nakamura K, Tomida M, Ando T, Sen K, Inokuchi R, Kobayashi E, Nakajima S, Sakuma I, Yahagi N. Cardiac variation of inferior vena cava: new concept in the evaluation of intravascular blood volume. J Med Ultrason (2001). 2013 Jul;40(3):205-9. doi: 10.1007/s10396-013-0435-6. Epub 2013 Feb 27.

    PMID: 27277237BACKGROUND
  • Nakamura K, Qian K, Ando T, Inokuchi R, Doi K, Kobayashi E, Sakuma I, Nakajima S, Yahagi N. Cardiac Variation of Internal Jugular Vein for the Evaluation of Hemodynamics. Ultrasound Med Biol. 2016 Aug;42(8):1764-70. doi: 10.1016/j.ultrasmedbio.2016.03.003. Epub 2016 Apr 20.

    PMID: 27108039BACKGROUND
  • Akilli NB, Cander B, Dundar ZD, Koylu R. A new parameter for the diagnosis of hemorrhagic shock: jugular index. J Crit Care. 2012 Oct;27(5):530.e13-8. doi: 10.1016/j.jcrc.2012.01.011. Epub 2012 Mar 3.

    PMID: 22386226BACKGROUND
  • Preau S, Saulnier F, Dewavrin F, Durocher A, Chagnon JL. Passive leg raising is predictive of fluid responsiveness in spontaneously breathing patients with severe sepsis or acute pancreatitis. Crit Care Med. 2010 Mar;38(3):819-25. doi: 10.1097/CCM.0b013e3181c8fe7a.

    PMID: 20016380BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Asli Melek
Organization
Hacettepe University

Study Officials

  • Asli Melek

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

November 16, 2019

First Posted

November 22, 2019

Study Start

January 5, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 31, 2020

Results First Posted

August 31, 2020

Record last verified: 2020-08

Locations