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Effect of High-Flow Nasal Cannula on IVC Measurements Using Point of Care Ultrasound

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ClinicalTrials.gov Identifier: NCT05264454
Recruitment Status : Not yet recruiting
First Posted : March 3, 2022
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Edmund Tan, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Fluid Overload Device: high flow nasal cannulae Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: intervention will be blinded to those assessing the size of the IVC
Primary Purpose: Diagnostic
Official Title: Effect of High-Flow Nasal Cannula on IVC Measurements Using Point of Care Ultrasound
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Placebo Comparator: 0 L
This will be the arm where the baseline IVC assessment size is conducted at
Device: high flow nasal cannulae
The plan is to examine the effects of the size of the IVC size based upon varrying levels of high flow nasal cannulae flow
Other Name: point of care ultrasound

Active Comparator: 30 L
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
The plan is to examine the effects of the size of the IVC size based upon varrying levels of high flow nasal cannulae flow
Other Name: point of care ultrasound

Active Comparator: 60 L
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
The plan is to examine the effects of the size of the IVC size based upon varrying levels of high flow nasal cannulae flow
Other Name: point of care ultrasound




Primary Outcome Measures :
  1. Inferior vena cava maximal diameter in millimeter [ Time Frame: 3 minutes after the intervention ]

Secondary Outcome Measures :
  1. Inferior vena cava maximal collapsibility index [ Time Frame: 3 minutes after the intervention ]
    [(Maximum diameter Inferior vena cava -Minimum diameter) / Maximum diameter Inferior vena cava] x 100



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ambulatory
  • 18-40 years old

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05264454


Locations
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Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3G1
Sponsors and Collaborators
Nova Scotia Health Authority
Publications:
Navaneelan T. Deaths involving sepsis in Canada. Health at a Glance. 2016;(82):11.
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.

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Responsible Party: Edmund Tan, Physician Lead, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT05264454    
Other Study ID Numbers: HFNCIVC1
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No