Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01672242
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2012-08-09
Brief Title:
Assessment of End Expiratory Lung Volumes in Healthy Subjects Using High Flow Oxygen Vapotherm
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Assessment of End Expiratory Lung Volumes in Healthy Subjects Using High Flow Oxygen Vapotherm
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Respiratory distress is a common problem in an intensive care unit There are multiple mechanisms that are used to help patients who are in respiratory distress including mechanical ventilation continuous positive airway pressure CPAP bilevel positive airway pressure BiPAP high flow oxygen and oxygen supplementation through nasal cannula or a facemask
The purpose of this study is to evaluate the mechanism by which Vapotherm a high flow oxygen system provides breathing support Vapotherm provides high flow oxygen at different flow rates meaning one can increase the amount of oxygen flow to help with breathing support The investigators believe that this high flow oxygen system may provide similar breathing support that a continuous positive airway pressure machine CPAP machine does
The purpose of this study is to evaluate the mechanism by which Vapotherm a high flow oxygen system provides breathing support Vapotherm provides high flow oxygen at different flow rates meaning one can increase the amount of oxygen flow to help with breathing support The investigators believe that this high flow oxygen system may provide similar breathing support that a continuous positive airway pressure machine CPAP machine does
Detailed Description:
High flow nasal cannula oxygen therapy HFNC is a method of oxygen delivery now commonly used in persistently hypoxic patients refractory to conventional modes of oxygen supplementation ie nasal cannula facemask non-rebreather facemask Initially used in neonates it is now increasingly popular in the adult population While the investigators know how HFNC provides oxygen supplementation the physiologic mechanism of correcting hypoxemia is still unclear There are five mechanisms of hypoxemia four which correct with oxygen supplementation - decreased fraction of inspired oxygen FiO2 hyperventilation ventilation-perfusion VQ mismatch and diffusion defect and one that does not - shunt The hypoxemia refractory to supplemental oxygen suggests the presence of physiologic shunt The conventional non-invasive therapy to reduce shunt fraction requires raising end-expiratory lung volumes by raising end-expiratory airway pressures using the application of continuous positive airway pressure CPAP or bilevel positive airway pressure BiPAP The Vapotherm Vapotherm Stevensville Maryland product of high flow oxygen therapy Precision Flow is one the investigators frequently use in intensive care units at the University of Maryland Medical Center It does not create a leak proof seal in the nose as seen in CPAP and BiPAP Positive pressure generation has been studied in another high flow oxygen system called Optiflow Fisher Paykel Healthcare Ltd Auckland New Zealand However this device differs from Vapotherm in that its nasal bores are large and create a seal in each nares thereby affected both ventilation and the level of positive end expiratory pressure PEEP generation Additionally these studies measured positive expiratory lung pressures not volume Positive end expiratory alveolar pressure and increase expiratory lung volumes in adults have not yet been demonstrated using Precision Flow
HFNC is intriguing because studies and clinical data have shown it is a relatively non-invasive method of oxygen delivery that appears to correct hypoxemia better than other non-invasive methods It is more comfortable than a CPAP machine and thus is better tolerated among patients especially those who are critically ill and possibly altered While it has been used in neonates for some time its use with adults is new and needs more research
The investigators hypothesis is that HFNC corrects persistent hypoxemia by producing increased end-expiratory lung volumes thus keeping alveoli open throughout the respiratory cycle which other oxygen supplements are unable to do Using healthy volunteers the investigators will measure end expiratory lung volumes on HFNC and compare them to those obtained with CPAP at graded pressures
HFNC is intriguing because studies and clinical data have shown it is a relatively non-invasive method of oxygen delivery that appears to correct hypoxemia better than other non-invasive methods It is more comfortable than a CPAP machine and thus is better tolerated among patients especially those who are critically ill and possibly altered While it has been used in neonates for some time its use with adults is new and needs more research
The investigators hypothesis is that HFNC corrects persistent hypoxemia by producing increased end-expiratory lung volumes thus keeping alveoli open throughout the respiratory cycle which other oxygen supplements are unable to do Using healthy volunteers the investigators will measure end expiratory lung volumes on HFNC and compare them to those obtained with CPAP at graded pressures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None