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

Fluid Overload Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05264454
• Other study ID #: HFNCIVC1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2022
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Shock is a state of decreased perfusion and inadequate oxygen delivery to tissues. This results in end organ damage and is associated with high morbidity and mortality, regardless of etiology. Shock associated with an infection is known as septic shock. In the intensive care unit (ICU) population, septic shock is the most common admission to the ICU and, with a mortality rate approaching 30%, is one of the leading causes of death. Early antibiotics and early intravenous fluid administration are a key component of resuscitation, but over-resuscitation with fluids is associated with adverse outcomes, including death. Therefore, methods to determine the ideal amount of fluid to administer are required.

Increasingly, the use of a bedside ultrasound, known as point of care ultrasound (PoCUS), can be used to determine the cause of shock and to help guide the ideal amount of fluid administration. One method for determining the appropriate amount of fluid to administer is the measurement of the size of the inferior vena cava (IVC). The IVC is a large vein that travels through the abdomen and delivers blood back to the heart. In a breathing patient, the size of the IVC varies with the breathing cycle. During inspiration the contraction of the diaphragm results in the generation of a negative pressure inside the chest cavity. This pressure change results in a decrease in size of the IVC during inspiration; contrary, during expiration, the IVC will be maximally distended. One of the best methods for determining fluid responsiveness using IVC is known as the IVC collapsibility index, which is defined as the [(Maximum diameter IVC-Minimum diameter) / Maximum diameter IVC] x 100. If the index is greater than 41% (range, 40%-42%), the LR ranged from 3.5 (95% CI, 1.1-15) to 9.3 (95% CI, 0.88-51) that the patient would respond to fluid.

One limitation to the use of PoCUS to assess the IVC is that the size of the vessel is affected by pressure inside the chest cavity. For example, patients who have obstructive sleep apnea (OSA) are often treated using a device called a continuous positive airway pressure (CPAP) machine. CPAP works by applying a constant amount of air pressure to prevent the soft tissues in the neck from collapsing and obstructing the airway. This constant pressure results in an increase of the chest cavity pressure which has been shown to increase the IVC diameter and a decreased IVC collapsibility index. This could result in an error in not administering fluid when the patient would benefit from it.

A patient population where this error may occur are those admitted to hospital with pneumonia. Pneumonia is the most common presentation of septic shock in critical care. Often times these patients present with septic shock as well as respiratory failure, which is treated with supplemental oxygen. Increasingly, high flow nasal cannulas (HFNC) have been used in the initial management of respiratory failure. Studies in the critically ill populations have demonstrated that, compared to conventional oxygen therapy, HFNC provides superior oxygenation and decreases the need for intubation. HFNC is a device that is able to generate very high flows (up to 60 L/min) at an adjustable FiO2 such that even at very high peak inspiratory flows (i.e. breathing in quickly), FiO2 remains consistent. These high flows generate a CPAP effect, with an approximately linear relationship of 1 cmH2O for every 10 L/min of flow. Therefore, it is possible that patients who are placed on HFNC may have an artificially enlarged IVC measurement by ultrasound.

Considering the increasing scope and utilization of PoCUS as well as HFNC in the treatment of respiratory failure, it is important to establish what effect HFNC has on POCUS IVC measurements. To date, only one study has examined the effect of HFNC on the size of IVC. This study was conducted in heart failure patients where the patients were all volume overloaded (distended IVC). The study placed patients in heart failure on HFNC on flows of 20 and 40L/min which resulted in a decrease in the IVC collapsibility index. However, no study has examined the effect of HFNC non-volume overloaded patients at 60L /min.

Our hypothesis is that the application of HFNC will increase in the size of the IVC and decrease the IVC collapsibility index in healthy patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluid Overload

Intervention

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

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (18)

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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. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inferior vena cava maximal diameter in millimeter		3 minutes after the intervention
Secondary	Inferior vena cava maximal collapsibility index	[(Maximum diameter Inferior vena cava -Minimum diameter) / Maximum diameter Inferior vena cava] x 100	3 minutes after the intervention