Critically IllNCT04173741
Is There Any Correlation Between Respiratory Variation Ratios of Internal Jugular Vein and Inferior Vena Cava?
An observational study of Critically Ill, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- USG measurement
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Mechanically ventilated patients in the intensive care unit over 18 years of age
Who may be able to join
- Mechanically ventilated
- Over 18 years of age
Who cannot join
- Infection in the site of measurement areas
- Surgical sutures in the site of measurement areas
- Intraabdominal hypertension
- Severe aortic regurgitation
- Lower extremity amputation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Hospital Anesthesiology Intensive Care Unit
Ankara
About this study
Official title: A Correlation Study in the Intensive Care Unit Between the Respiratory Variation Ratios of Internal Jugular Vein and Inferior Vena Cava Before and After Passive Leg Raise
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.
Read the detailed description
The investigators measure the internal jugular vein (IJV) diameter in the short axis by using the linear probe (12-5 MHz) and M-mode of the ultrasound device in the junction of cricothyroid membrane level and midclavicular line. The inferior vena cava (IVC) is visualized in the subxiphoid long axis by using the convex probe (5-1 MHz). Diameter of the IVC is measured 2 cm caudally to the junction of the hepatic vein in M-mode. All measurements are done separately by 3 different doctors; one senior anesthesiology resident, one anesthesiology and critical care medicine fellow and one professor in anesthesiology and critical care. The first measurements of the IVC and the IJV are done in the supine position and the second ones are done after passive leg raise. Passive leg raise is done for 1 minute in the first group and for 3 minutes in the second group. Then distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices are calculated. No fluid therapy or medication are given to the patients according to these measurements.
Oxygen saturation, hearth rate and blood pressure levels are recorded before and after the measurements. The investigators also record age, gender, weight, height, body mass index, causes of admission, comorbidities, ventilator settings, vasoactive and diuretic medications, fluid intake and output volumes, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sepsis-Related Organ Failure Assessment (SOFA) scores in the day of admission, Acute Physiology Score (APS) and SOFA scores in the day of measurement and length of stay in the intensive care unit.
Patients with infection or surgical sutures in the site of measurement areas, intraabdominal hypertension, severe aortic regurgitation or lower extremity amputation history are excluded from the study.
- Conditions
- Critically Ill
- Being tested
- USG measurement
- Keywords
- Positive Pressure Ventilation, Fluid Responsiveness, Passive Leg Raise, Inferior Vena Cava, Internal Jugular Vein, Interobserver Variability, Ultrasound
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Leg Rise Position - 3 Minutes | Patients who stayed in passive leg rise position for 3 minutes Receives: Other: USG measurement | |
| Leg Rise Position - 1 Minute | Patients who stayed in passive leg rise position for 1 minute Receives: Other: USG measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start5 Jan 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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 Hacettepe UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Melek, Hacettepe University
- Investigators
- Asli Melek, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173741
- Sponsor's protocol ID
- GO 17/427
- Status last verified
- Aug 2020
- First submitted
- 16 Nov 2019
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27277237Nakamura 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.
PubMed 27108039Akilli 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.
PubMed 22386226Preau 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.
PubMed 20016380
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlation Study in the Intensive Care Unit Between the Respiratory Variation Ratios of Internal Jugular Vein and Inferior Vena Cava Before and After Passive Leg Raise
- ClinicalTrials.gov ID
- NCT04173741
- Acronym / sponsor ID
- GO 17/427
- Conditions
- Critically Ill
- Keywords
- Positive Pressure Ventilation, Fluid Responsiveness, Passive Leg Raise, Inferior Vena Cava, Internal Jugular Vein, Interobserver Variability, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators measure the internal jugular vein (IJV) diameter in the short axis by using the linear probe (12-5 MHz) and M-mode of the ultrasound device in the junction of cricothyroid membrane level and midclavicular line. The inferior vena cava (IVC) is visualized in the subxiphoid long axis by using the convex probe (5-1 MHz). Diameter of the IVC is measured 2 cm caudally to the junction of the hepatic vein in M-mode. All measurements are done separately by 3 different doctors; one senior anesthesiology resident, one anesthesiology and critical care medicine fellow and one professor in anesthesiology and critical care. The first measurements of the IVC and the IJV are done in the supine position and the second ones are done after passive leg raise. Passive leg raise is done for 1 minute in the first group and for 3 minutes in the second group. Then distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices are calculated. No fluid therapy or medication are given to the patients according to these measurements.
Oxygen saturation, hearth rate and blood pressure levels are recorded before and after the measurements. The investigators also record age, gender, weight, height, body mass index, causes of admission, comorbidities, ventilator settings, vasoactive and diuretic medications, fluid intake and output volumes, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sepsis-Related Organ Failure Assessment (SOFA) scores in the day of admission, Acute Physiology Score (APS) and SOFA scores in the day of measurement and length of stay in the intensive care unit.
Patients with infection or surgical sutures in the site of measurement areas, intraabdominal hypertension, severe aortic regurgitation or lower extremity amputation history are excluded from the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leg Rise Position - 3 Minutes | – | Other: USG measurementPatients who stayed in passive leg rise position for 3 minutes |
| Leg Rise Position - 1 Minute | – | Other: USG measurementPatients who stayed in passive leg rise position for 1 minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients in the intensive care unit over 18 years of age
Key inclusion criteria (2 listed)
- Mechanically ventilated
- Over 18 years of age
Key exclusion criteria (5 listed)
- Infection in the site of measurement areas
- Surgical sutures in the site of measurement areas
- Intraabdominal hypertension
- Severe aortic regurgitation
- Lower extremity amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USG measurementIVC 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. | Other | Leg Rise Position - 1 Minute, Leg Rise Position - 3 Minutes |
Primary outcome
Ultrasonography (USG) Measurements
Time frame: through study completion, 3 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27277237Nakamura 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.
- Background: PubMed 27108039Nakamura 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.
- Background: PubMed 22386226Akilli 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.
- Background: PubMed 20016380Preau 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.
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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.
Asli Melek principal investigator
Hacettepe University
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 Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 31 Aug 2020. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ultrasonography (USG) Measurements (time frame: through study completion, 3 days). 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 NCT04173741, which also lists 4 linked publications.
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 31 Aug 2020.