NCT05264454

Brief Summary

The size of the inferior vena cava (IVC) using point of care ultrasound is used in resuscitation of patients who are critically ill and is now being used as a standard part of resuscitation in many clinical situations. Multiple factors can effect the size of the IVC including the type of oxygen devices the patient is currently on. In the ICU setting, the use of High Flow Nasal Cannula (HFNC) is often used to help in patients who are critically ill. There is some evidence to suggest that the use of HFNC can effect the size of the IVC measurement but the extent of the effect has not been well characterized. The purpose of this study is to determine the effect HFNC has on the size of the IVC measured using a point of care ultrasound.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 2, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

December 2, 2021

Last Update Submit

August 19, 2024

Conditions

Fluid Overload

Outcome Measures

Primary Outcomes (1)

  • Inferior vena cava maximal diameter in millimeter

    3 minutes after the intervention

Secondary Outcomes (1)

  • Inferior vena cava maximal collapsibility index

    3 minutes after the intervention

Study Arms (3)

0 L

PLACEBO COMPARATOR

This will be the arm where the baseline IVC assessment size is conducted at

Device: high flow nasal cannulae

30 L

ACTIVE COMPARATOR

The HFNC flow will be set at 30 L / min. The IVC size will then be assessed using a POCUS

Device: high flow nasal cannulae

60 L

ACTIVE COMPARATOR

The HFNC flow will be set at 60 L / min. The IVC size will then be assessed using a POCUS

Device: high flow nasal cannulae

Interventions

high flow nasal cannulaeDEVICE

The plan is to examine the effects of the size of the IVC size based upon varrying levels of high flow nasal cannulae flow

Also known as: point of care ultrasound
0 L30 L60 L

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ambulatory
  • years old

You may not qualify if:

  • Severe lung disease (e.g. poorly controlled asthma, COPD with FEV1 \<40%)
  • Congestive heart failure (diastolic dysfunction, ejection fraction \< 50%, severe valvular disorders)
  • Renal failure
  • Complete nasal obstruction or facial deformities
  • BMI \> 30
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3G1, Canada

Location

Related Publications (18)

  • Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2014 Feb 6;370(6):583. doi: 10.1056/NEJMc1314999. No abstract available.

    PMID: 24499231BACKGROUND

  • Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.

    PMID: 23984731BACKGROUND

  • Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

    PMID: 11445675BACKGROUND

  • Navaneelan T. Deaths involving sepsis in Canada. Health at a Glance. 2016;(82):11.

    BACKGROUND

  • Mayr FB, Yende S, Angus DC. Epidemiology of severe sepsis. Virulence. 2014 Jan 1;5(1):4-11. doi: 10.4161/viru.27372. Epub 2013 Dec 11.

    PMID: 24335434BACKGROUND

  • Marik PE, Linde-Zwirble WT, Bittner EA, Sahatjian J, Hansell D. Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med. 2017 May;43(5):625-632. doi: 10.1007/s00134-016-4675-y. Epub 2017 Jan 27.

    PMID: 28130687BACKGROUND

  • Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

    PMID: 28101605BACKGROUND

  • 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. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

    PMID: 16714767BACKGROUND

  • Chaves RCF, Correa TD, Neto AS, Bravim BA, Cordioli RL, Moreira FT, Timenetsky KT, de Assuncao MSC. Assessment of fluid responsiveness in spontaneously breathing patients: a systematic review of literature. Ann Intensive Care. 2018 Feb 9;8(1):21. doi: 10.1186/s13613-018-0365-y.

    PMID: 29427013BACKGROUND

  • Perera P, Mailhot T, Riley D, Mandavia D. The RUSH exam: Rapid Ultrasound in SHock in the evaluation of the critically lll. Emerg Med Clin North Am. 2010 Feb;28(1):29-56, vii. doi: 10.1016/j.emc.2009.09.010.

    PMID: 19945597BACKGROUND

  • Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will This Hemodynamically Unstable Patient Respond to a Bolus of Intravenous Fluids? JAMA. 2016 Sep 27;316(12):1298-309. doi: 10.1001/jama.2016.12310.

    PMID: 27673307BACKGROUND

  • Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.

    PMID: 23043910BACKGROUND

  • Airapetian N, Maizel J, Alyamani O, Mahjoub Y, Lorne E, Levrard M, Ammenouche N, Seydi A, Tinturier F, Lobjoie E, Dupont H, Slama M. Does inferior vena cava respiratory variability predict fluid responsiveness in spontaneously breathing patients? Crit Care. 2015 Nov 13;19:400. doi: 10.1186/s13054-015-1100-9.

    PMID: 26563768BACKGROUND

  • Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.

    PMID: 20620859BACKGROUND

  • Jenkinson C, Davies RJ, Mullins R, Stradling JR. Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial. Lancet. 1999 Jun 19;353(9170):2100-5. doi: 10.1016/S0140-6736(98)10532-9.

    PMID: 10382693BACKGROUND

  • Au SY, Lau CL, Chen KK, Cheong AP, Tong YT, Chan LK. Hemodynamic Effects of Noninvasive Positive-Pressure Ventilation Assessed Using Transthoracic Echocardiography. J Cardiovasc Echogr. 2018 Apr-Jun;28(2):114-119. doi: 10.4103/jcecho.jcecho_53_17.

    PMID: 29911008BACKGROUND

  • Lee CC, Mankodi D, Shaharyar S, Ravindranathan S, Danckers M, Herscovici P, Moor M, Ferrer G. High flow nasal cannula versus conventional oxygen therapy and non-invasive ventilation in adults with acute hypoxemic respiratory failure: A systematic review. Respir Med. 2016 Dec;121:100-108. doi: 10.1016/j.rmed.2016.11.004. Epub 2016 Nov 3.

    PMID: 27888983BACKGROUND

  • Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.

    PMID: 26329355BACKGROUND

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
intervention will be blinded to those assessing the size of the IVC
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

March 3, 2022

Study Start

July 1, 2022

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)