Assessment of End Expiratory Lung Volumes in Healthy Subjects Using High Flow Oxygen (Vapotherm®)

NCT ID: NCT01672242

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-04-30

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.

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 (i.e. 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 (V/Q) 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.

Conditions

Healthy Adult Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

HFNC

High Flow Nasal Cannula (HFNC) oxygen.

Group Type: EXPERIMENTAL

HFNC

Intervention Type: DEVICE

Graded high flow nasal cannula oxygen at 10, 20 , 30, and 40 liters per minute (LPM) to each subject and end-expiratory lung volume measured by respiratory inductive plethysmography.

CPAP

Continuous Positive Airway Pressure (CPAP)

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

Graded contiuous positive airway pressure at 5, 10 , 15, and 20 cm H2O applied to each subject and end-expiratory lung volume measured by respiratory inductive plethysmography.

Interventions

HFNC

Graded high flow nasal cannula oxygen at 10, 20 , 30, and 40 liters per minute (LPM) to each subject and end-expiratory lung volume measured by respiratory inductive plethysmography.

Intervention Type: DEVICE

CPAP

Graded contiuous positive airway pressure at 5, 10 , 15, and 20 cm H2O applied to each subject and end-expiratory lung volume measured by respiratory inductive plethysmography.

Intervention Type: DEVICE

Other Intervention Names

High flow nasal cannula oxygen, Precision Flow®, Vapotherm®; Continuous positive airway pressure, Respironics(R)

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 75
• Able to follow and understand simple instructions to collect spirometry

Exclusion Criteria

• Younger than 18y/o
• Older than 75 years old
• History of chronic obstructive pulmonary disease (COPD)
• History of asthma
• History of congestive heart failure
• Measured ratio of forced expiratory volume at 1 second/forced vital capacity (FEV1/FVC) <70 when undergoing spirometry

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vapotherm, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Carl Shanholtz

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carl B. Shanholtz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

University of Maryland School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00052656

Identifier Type: -

Identifier Source: org_study_id