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

Unintubated Patients in ICU and Resuscitation Room Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535038
• Other study ID #: IndonesiaUAnes023
• Status: Completed
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 1, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• BMI >35, intubated

• History of thoracic or heart surgery

• History of external and internal radiation

• Pregnant

Related Conditions & MeSH terms

• Unintubated Patients in ICU and Resuscitation Room

Intervention

Diagnostic Test:
• Inferior vena cava (IVC) diameter using USG
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)
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.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (38)

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. Review. — View Citation

Bouchard J, Soroko SB, Chertow GM, Himmelfarb J, Ikizler TA, Paganini EP, Mehta RL; Program to Improve Care in Acute Renal Disease (PICARD) Study Group. Fluid accumulation, survival and recovery of kidney function in critically ill patients with acute kidney injury. Kidney Int. 2009 Aug;76(4):422-7. doi: 10.1038/ki.2009.159. Epub 2009 May 13. — View Citation

Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. Epub 2007 Apr 18. — View Citation

Çelebi 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. — View Citation

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. — View Citation

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. — View Citation

Eisenhuber E, Schaefer-Prokop CM, Prosch H, Schima W. Bedside chest radiography. Respir Care. 2012 Mar;57(3):427-43. doi: 10.4187/respcare.01712. Review. — View Citation

Ely EW, Haponik EF. Using the chest radiograph to determine intravascular volume status: the role of vascular pedicle width. Chest. 2002 Mar;121(3):942-50. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Kent A, Patil P, Davila V, Bailey JK, Jones C, Evans DC, Boulger CT, Adkins E, Balakrishnan JM, Valiyaveedan S, Galwankar SC, Bahner DP, Stawicki SP. Sonographic evaluation of intravascular volume status: Can internal jugular or femoral vein collapsibility be used in the absence of IVC visualization? Ann Thorac Med. 2015 Jan-Mar;10(1):44-9. doi: 10.4103/1817-1737.146872. — View Citation

Lyon M, Blaivas M, Brannam L. Sonographic measurement of the inferior vena cava as a marker of blood loss. Am J Emerg Med. 2005 Jan;23(1):45-50. — View Citation

Mackenzie DC, Noble VE. Assessing volume status and fluid responsiveness in the emergency department. Clin Exp Emerg Med. 2014 Dec 31;1(2):67-77. eCollection 2014 Dec. Review. — View Citation

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. — View Citation

Marx G, Schindler AW, Mosch C, Albers J, Bauer M, Gnass I, Hobohm C, Janssens U, Kluge S, Kranke P, Maurer T, Merz W, Neugebauer E, Quintel M, Senninger N, Trampisch HJ, Waydhas C, Wildenauer R, Zacharowski K, Eikermann M. Intravascular volume therapy in adults: Guidelines from the Association of the Scientific Medical Societies in Germany. Eur J Anaesthesiol. 2016 Jul;33(7):488-521. doi: 10.1097/EJA.0000000000000447. Review. — View Citation

Michard F. Underutilized tools for the assessment of intravascular volume status. Chest. 2003 Jul;124(1):414-5; author reply 415-6. — View Citation

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. Review. — View Citation

Murphy CV, Schramm GE, Doherty JA, Reichley RM, Gajic O, Afessa B, Micek ST, Kollef MH. The importance of fluid management in acute lung injury secondary to septic shock. Chest. 2009 Jul;136(1):102-109. doi: 10.1378/chest.08-2706. Epub 2009 Mar 24. — View Citation

National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network, Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. Epub 2006 May 21. — View Citation

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. — View Citation

Rice TW, Ware LB, Haponik EF, Chiles C, Wheeler AP, Bernard GR, Steingrub JS, Hite RD, Matthay MA, Wright P, Ely EW; NIH NHLBI ARDS Network. Vascular pedicle width in acute lung injury: correlation with intravascular pressures and ability to discriminate fluid status. Crit Care. 2011;15(2):R86. doi: 10.1186/cc10084. Epub 2011 Mar 7. — View Citation

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. — View Citation

Sakurai T, Ando Y, Masunaga Y, Kusano E, Asano Y. Diameter of the inferior vena cava as an index of dry weight in patients undergoing CAPD. Perit Dial Int. 1996 Mar-Apr;16(2):183-5. — View Citation

Salahuddin N, Hussain I, Alsaidi H, Shaikh Q, Joseph M, Hawa H, Maghrabi K. Measurement of the vascular pedicle width predicts fluid repletion: a cross-sectional comparison with inferior vena cava ultrasound and lung comets. J Intensive Care. 2015 Dec 22;3:55. doi: 10.1186/s40560-015-0121-4. eCollection 2015. — View Citation

Sefidbakht S, Assadsangabi R, Abbasi HR, Nabavizadeh A. Sonographic measurement of the inferior vena cava as a predictor of shock in trauma patients. Emerg Radiol. 2007 Jul;14(3):181-5. Epub 2007 Jun 1. — View Citation

Stein A, de Souza LV, Belettini CR, Menegazzo WR, Viégas JR, Costa Pereira EM, Eick R, Araújo 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. — View Citation

Taghizadieh A, Nia KS, Moharramzadeh P, Pouraghaei M, Ghavidel A, Parsian Z, Mahmoodpoor A. The PCQP Score for Volume Status of Acutely Ill Patients: Integrating Vascular Pedicle Width, Caval Index, Respiratory Variability of the QRS Complex and R Wave Amplitude. Indian J Crit Care Med. 2017 Nov;21(11):726-732. doi: 10.4103/ijccm.IJCCM_275_17. — View Citation

Thanakitcharu P, Charoenwut M, Siriwiwatanakul N. Inferior vena cava diameter and collapsibility index: a practical non-invasive evaluation of intravascular fluid volume in critically-ill patients. J Med Assoc Thai. 2013 Mar;96 Suppl 3:S14-22. — View Citation

Thomason JW, Ely EW, Chiles C, Ferretti G, Freimanis RI, Haponik EF. Appraising pulmonary edema using supine chest roentgenograms in ventilated patients. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1600-8. — View Citation

Wang H, Shi R, Mahler S, Gaspard J, Gorchynski J, D'Etienne J, Arnold T. Vascular pedicle width on chest radiograph as a measure of volume overload: meta-analysis. West J Emerg Med. 2011 Nov;12(4):426-32. doi: 10.5811/westjem.2011.3.2023. — View Citation

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. — View Citation

Zengin S, Al B, Genc S, Yildirim C, Ercan S, Dogan M, Altunbas G. Role of inferior vena cava and right ventricular diameter in assessment of volume status: a comparative study: ultrasound and hypovolemia. Am J Emerg Med. 2013 May;31(5):763-7. doi: 10.1016/j.ajem.2012.10.013. Epub 2013 Apr 17. — View Citation

Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002. — View Citation

Zhang Z, Xu X, Ye S, Xu L. Ultrasonographic measurement of the respiratory variation in the inferior vena cava diameter is predictive of fluid responsiveness in critically ill patients: systematic review and meta-analysis. Ultrasound Med Biol. 2014 May;40(5):845-53. doi: 10.1016/j.ultrasmedbio.2013.12.010. Epub 2014 Feb 2. Review. — View Citation

Zhao J, Wang G. Inferior Vena Cava Collapsibility Index is a Valuable and Non-Invasive Index for Elevated General Heart End-Diastolic Volume Index Estimation in Septic Shock Patients. Med Sci Monit. 2016 Oct 20;22:3843-3848. — View Citation

* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravascular volume measurement	Measured by VPW and IVC diameter using USG	IVC is measured 30 minutes after VPW