Unintubated Patients in ICU and Resuscitation RoomNCT03535038

Measurement of Intravascular Volume Using USG of IVC Diameter Compared to VPW Chest X-ray

A study testing Inferior vena cava (IVC) diameter using USG and Vascular pedicle width (VPW) in people with Unintubated Patients in ICU and Resuscitation Room, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study aimed to know the consistency of intravascular volume measurement using USG of IVC compared to VPW chest x-ray Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Unintubated Patients in ICU and Resuscitation Room
What is being tested?: Inferior vena cava (IVC) diameter using USG and Vascular pedicle width (VPW)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteIndonesia
Study dates: 31 May 2018to 1 Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult non-intubated patients aged 18-65 in ICU or resucitation room
BMI 18.5-35 kg/m2
Signed informed consent of the patient to be included in the study

Who cannot join

BMI >35, intubated
History of thoracic or heart surgery
History of external and internal radiation
Pregnant

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Agreement Test of Intravascular Volume Assessment Between Inferior Vena Cava (IVC) Diameter and Vascular Pedicle Width (VPW)

This study aimed to know the consistency of intravascular volume measurement using USG of IVC compared to VPW chest x-ray

Read the detailed description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Validation and reliability test were done for USG operators by assessing IVC in 20 patients supervised by intensivists. Subjects were given informed consent before participating in the study. Subjects underwent the chest x-ray examination with supine position. The measurement of VPW was done by radiologists, considered normal if the value is 53 ± 5 mm, overload if VPW > 71 mm. The subjects then underwent the IVC diameter measurement using USG Philips En Visor C, with transthoracal subcostal approach. The result is considered normal if IVC diameter is 1.5 - 2.5 cm and overload if >2.5 cm, otherwise the subjects is excluded. If the IVC can not be done, subjects will be excluded.

Conditions: Unintubated Patients in ICU and Resuscitation Room
Being tested: Inferior vena cava (IVC) diameter using USG, Vascular pedicle width (VPW)
Keywords: Intravascular volume, Inferior vena cava diameter, Ultrasonography, Vascular Pedicle Width, Chest x-ray

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inferior vena cava (IVC) diameter using USGDiagnostic test
IVC diameter is measured from the distal of right hepatic pain and inferior vena cava meeting point using Philips En Visor C USG.
Vascular pedicle width (VPW)Diagnostic test
VPW is measured by drawing a line from the left subclavian artery exit point from aorta perpendicular to the point where superior vena cava crosses with right bronchi.

Study groups in NCT03535038
Study group	Role	What they receive
Inferior vena cava (IVC) diameter	Experimental	subjects underwent IVC diameter measurement after VPW measurement Receives: Diagnostic Test: Inferior vena cava (IVC) diameter using USG
Vascular pedicle width (VPW)	Active comparator	Supine chest x ray was done and the VPW is assessed by radiologists. Receives: Diagnostic Test: Vascular pedicle width (VPW)

What is being measured

The primary outcome is the main question the study is designed to answer.

Intravascular volume measurement
Measured by VPW and IVC diameter using USG
Measured: IVC is measured 30 minutes after VPW

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 20181 Dec 2018

First posted24 May 2018
Study start31 May 2018
Primary completion31 Jul 2018
Study completion1 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (38)Papers the sponsor has linked to this study.
Other trials for Unintubated Patients in ICU and Resuscitation RoomStudies of the same condition, open and under way.
More trials run by Universitas IndonesiaThe 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03535038
Sponsor's protocol ID: IndonesiaUAnes023
Status last verified: Jan 2019
First submitted: 12 May 2018
Last updated: 17 Jan 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Beaubien-Souligny W, Bouchard J, Desjardins G, Lamarche Y, Liszkowski M, Robillard P, Denault A. Extracardiac Signs of Fluid Overload in the Critically Ill Cardiac Patient: A Focused Evaluation Using Bedside Ultrasound. Can J Cardiol. 2017 Jan;33(1):88-100. doi: 10.1016/j.cjca.2016.08.012. Epub 2016 Aug 24.
PubMed 27887762
Ferrada P, Anand RJ, Whelan J, Aboutanos MA, Duane T, Malhotra A, Ivatury R. Qualitative assessment of the inferior vena cava: useful tool for the evaluation of fluid status in critically ill patients. Am Surg. 2012 Apr;78(4):468-70.
PubMed 22472406
Cordemans C, De Laet I, Van Regenmortel N, Schoonheydt K, Dits H, Huber W, Malbrain ML. Fluid management in critically ill patients: the role of extravascular lung water, abdominal hypertension, capillary leak, and fluid balance. Ann Intensive Care. 2012 Jul 5;2(Suppl 1 Diagnosis and management of intra-abdominal hyperten):S1. doi: 10.1186/2110-5820-2-S1-S1. eCollection 2012.
PubMed 22873410
Dass B, Shimada M, Kambhampati G, Ejaz NI, Arif AA, Ejaz AA. Fluid balance as an early indicator of acute kidney injury in CV surgery. Clin Nephrol. 2012 Jun;77(6):438-44. doi: 10.5414/cn107278.
PubMed 22595385
Grams ME, Estrella MM, Coresh J, Brower RG, Liu KD; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Fluid balance, diuretic use, and mortality in acute kidney injury. Clin J Am Soc Nephrol. 2011 May;6(5):966-73. doi: 10.2215/CJN.08781010. Epub 2011 Mar 10.
PubMed 21393482
Rosenberg AL, Dechert RE, Park PK, Bartlett RH; NIH NHLBI ARDS Network. Review of a large clinical series: association of cumulative fluid balance on outcome in acute lung injury: a retrospective review of the ARDSnet tidal volume study cohort. J Intensive Care Med. 2009 Jan-Feb;24(1):35-46. doi: 10.1177/0885066608329850. Epub 2008 Dec 22.
PubMed 19103612
Stein A, de Souza LV, Belettini CR, Menegazzo WR, Viegas JR, Costa Pereira EM, Eick R, Araujo L, Consolim-Colombo F, Irigoyen MC. Fluid overload and changes in serum creatinine after cardiac surgery: predictors of mortality and longer intensive care stay. A prospective cohort study. Crit Care. 2012 May 31;16(3):R99. doi: 10.1186/cc11368.
PubMed 22651844
Magee G, Zbrozek A. Fluid overload is associated with increases in length of stay and hospital costs: pooled analysis of data from more than 600 US hospitals. Clinicoecon Outcomes Res. 2013 Jun 26;5:289-96. doi: 10.2147/CEOR.S45873. Print 2013.
PubMed 23836999
Wichansawakul S, Vilaichone W, Tongyoo S, Permpikul C, Wonglaksanapimol S, Daengnim K, Suwanboonrit G. Evaluation of correlation between vascular pedicle width and intravascular volume status in Thai critically ill patients. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S181-7.
PubMed 21721445
Kalantari K, Chang JN, Ronco C, Rosner MH. Assessment of intravascular volume status and volume responsiveness in critically ill patients. Kidney Int. 2013 Jun;83(6):1017-28. doi: 10.1038/ki.2012.424. Epub 2013 Jan 9.
PubMed 23302716
Farshidpanah S, Klein W, Matus M, Sai A, Nguyen HB. Validation of the vascular pedicle width as a diagnostic aid in critically ill patients with pulmonary oedema by novice non-radiology physicians-in-training. Anaesth Intensive Care. 2014 May;42(3):321-9. doi: 10.1177/0310057X1404200308.
PubMed 24794471
Nik Muhamad NA, Safferi RS, Robertson CE. Internal Jugular Vein Height and Inferior Vena Cava Diameter Measurement using Ultrasound to Determine Central Venous Pressure: A Correlation Study. Med J Malaysia. 2015 Apr;70(2):63-6.
PubMed 26162379
Miller RR, Ely EW. Radiographic measures of intravascular volume status: the role of vascular pedicle width. Curr Opin Crit Care. 2006 Jun;12(3):255-62. doi: 10.1097/01.ccx.0000224871.31947.8d.
PubMed 16672786
Celebi Yamanoglu NG, Yamanoglu A, Parlak I, Pinar P, Tosun A, Erkuran B, Aydinok G, Torlak F. The role of inferior vena cava diameter in volume status monitoring; the best sonographic measurement method? Am J Emerg Med. 2015 Mar;33(3):433-8. doi: 10.1016/j.ajem.2014.12.014. Epub 2014 Dec 18.
PubMed 25616587
Frank Peacock W, Soto KM. Current technique of fluid status assessment. Congest Heart Fail. 2010 Jul;16 Suppl 1:S45-51. doi: 10.1111/j.1751-7133.2010.00166.x.
PubMed 20653711

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Agreement Test of Intravascular Volume Assessment Between Inferior Vena Cava (IVC) Diameter and Vascular Pedicle Width (VPW)
ClinicalTrials.gov ID: NCT03535038
Acronym / sponsor ID: IndonesiaUAnes023
Conditions: Unintubated Patients in ICU and Resuscitation Room
Keywords: Intravascular volume, Inferior vena cava diameter, Ultrasonography, Vascular Pedicle Width, Chest x-ray
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Study start: 31 May 2018 (actual)
Primary completion: 31 Jul 2018 (actual)
Study completion: 1 Dec 2018 (actual)
First posted: 24 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aimed to know the consistency of intravascular volume measurement using USG of IVC compared to VPW chest x-ray

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Inferior vena cava (IVC) diameter	Experimental	Diagnostic Test: Inferior vena cava (IVC) diameter using USGsubjects underwent IVC diameter measurement after VPW measurement
Vascular pedicle width (VPW)	Active comparator	Diagnostic Test: Vascular pedicle width (VPW)Supine chest x ray was done and the VPW is assessed by radiologists.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult non-intubated patients aged 18-65 in ICU or resucitation room
BMI 18.5-35 kg/m2
Signed informed consent of the patient to be included in the study

Key exclusion criteria (4 listed)

BMI >35, intubated
History of thoracic or heart surgery
History of external and internal radiation
Pregnant

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
Inferior vena cava (IVC) diameter using USGIVC diameter is measured from the distal of right hepatic pain and inferior vena cava meeting point using Philips En Visor C USG.	Diagnostic test	Inferior vena cava (IVC) diameter
Vascular pedicle width (VPW)VPW is measured by drawing a line from the left subclavian artery exit point from aorta perpendicular to the point where superior vena cava crosses with right bronchi.	Diagnostic test	Vascular pedicle width (VPW)

Primary outcome

Intravascular volume measurement
Time frame: IVC is measured 30 minutes after VPW
Measured by VPW and IVC diameter using USG

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
Background: PubMed 27887762Beaubien-Souligny W, Bouchard J, Desjardins G, Lamarche Y, Liszkowski M, Robillard P, Denault A. Extracardiac Signs of Fluid Overload in the Critically Ill Cardiac Patient: A Focused Evaluation Using Bedside Ultrasound. Can J Cardiol. 2017 Jan;33(1):88-100. doi: 10.1016/j.cjca.2016.08.012. Epub 2016 Aug 24.
Background: PubMed 22472406Ferrada P, Anand RJ, Whelan J, Aboutanos MA, Duane T, Malhotra A, Ivatury R. Qualitative assessment of the inferior vena cava: useful tool for the evaluation of fluid status in critically ill patients. Am Surg. 2012 Apr;78(4):468-70.
Background: PubMed 22873410Cordemans C, De Laet I, Van Regenmortel N, Schoonheydt K, Dits H, Huber W, Malbrain ML. Fluid management in critically ill patients: the role of extravascular lung water, abdominal hypertension, capillary leak, and fluid balance. Ann Intensive Care. 2012 Jul 5;2(Suppl 1 Diagnosis and management of intra-abdominal hyperten):S1. doi: 10.1186/2110-5820-2-S1-S1. eCollection 2012.
Background: PubMed 22595385Dass B, Shimada M, Kambhampati G, Ejaz NI, Arif AA, Ejaz AA. Fluid balance as an early indicator of acute kidney injury in CV surgery. Clin Nephrol. 2012 Jun;77(6):438-44. doi: 10.5414/cn107278.
Background: PubMed 21393482Grams ME, Estrella MM, Coresh J, Brower RG, Liu KD; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Fluid balance, diuretic use, and mortality in acute kidney injury. Clin J Am Soc Nephrol. 2011 May;6(5):966-73. doi: 10.2215/CJN.08781010. Epub 2011 Mar 10.
Background: PubMed 19103612Rosenberg AL, Dechert RE, Park PK, Bartlett RH; NIH NHLBI ARDS Network. Review of a large clinical series: association of cumulative fluid balance on outcome in acute lung injury: a retrospective review of the ARDSnet tidal volume study cohort. J Intensive Care Med. 2009 Jan-Feb;24(1):35-46. doi: 10.1177/0885066608329850. Epub 2008 Dec 22.
Background: PubMed 22651844Stein A, de Souza LV, Belettini CR, Menegazzo WR, Viegas JR, Costa Pereira EM, Eick R, Araujo L, Consolim-Colombo F, Irigoyen MC. Fluid overload and changes in serum creatinine after cardiac surgery: predictors of mortality and longer intensive care stay. A prospective cohort study. Crit Care. 2012 May 31;16(3):R99. doi: 10.1186/cc11368.
Background: PubMed 23836999Magee G, Zbrozek A. Fluid overload is associated with increases in length of stay and hospital costs: pooled analysis of data from more than 600 US hospitals. Clinicoecon Outcomes Res. 2013 Jun 26;5:289-96. doi: 10.2147/CEOR.S45873. Print 2013.
Background: PubMed 21721445Wichansawakul S, Vilaichone W, Tongyoo S, Permpikul C, Wonglaksanapimol S, Daengnim K, Suwanboonrit G. Evaluation of correlation between vascular pedicle width and intravascular volume status in Thai critically ill patients. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S181-7.
Background: PubMed 23302716Kalantari K, Chang JN, Ronco C, Rosner MH. Assessment of intravascular volume status and volume responsiveness in critically ill patients. Kidney Int. 2013 Jun;83(6):1017-28. doi: 10.1038/ki.2012.424. Epub 2013 Jan 9.
Background: PubMed 24794471Farshidpanah S, Klein W, Matus M, Sai A, Nguyen HB. Validation of the vascular pedicle width as a diagnostic aid in critically ill patients with pulmonary oedema by novice non-radiology physicians-in-training. Anaesth Intensive Care. 2014 May;42(3):321-9. doi: 10.1177/0310057X1404200308.
Background: PubMed 26162379Nik Muhamad NA, Safferi RS, Robertson CE. Internal Jugular Vein Height and Inferior Vena Cava Diameter Measurement using Ultrasound to Determine Central Venous Pressure: A Correlation Study. Med J Malaysia. 2015 Apr;70(2):63-6.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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 17 Jan 2019. 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 Indonesia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Intravascular volume measurement (time frame: IVC is measured 30 minutes after VPW). 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 NCT03535038, which also lists 38 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 17 Jan 2019.