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

NCT01672242 | Completed Results DMC

• 1 other identifier: HP-00052656
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

• Change in End-expiratory Lung Volume

  Change in end-expiratory lung volume from baseline arbitrarily set at 0 mL.

  baseline and after 3-5 minutes after each level of flow or pressure

Study Arms (2)

HFNC

EXPERIMENTAL

High Flow Nasal Cannula (HFNC) oxygen.

Device: HFNC

CPAP

EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Device: CPAP

Interventions

HFNC 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.

Also known as: High flow nasal cannula oxygen, Precision Flow®, Vapotherm®

HFNC

CPAP 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.

Also known as: Continuous positive airway pressure, Respironics(R)

CPAP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Vapotherm, Inc.: collaborator

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Carl Shanholtz, MD
• Organization: University of Maryland School of Medicine

cshanhol@som.umaryland.edu

410.328.8141

Study Officials

• Carl B. Shanholtz, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 24, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 8, 2022
• Results First Posted: January 10, 2018

Record last verified: 2022-03

Locations

US (1)