Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy

NCT03083379 | Completed Results FDA Device

• 1 other identifier: 19661
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine if there is a significant difference in regional distribution of ventilation when comparing eupneic tidal ventilation with Incentive Spirometry (I.S.) and EzPAP® lung expansion therapy in healthy adult human subjects. Electrical impedance tomography (EIT) will be used to measure regional distribution of ventilation during resting tidal ventilation and during lung expansion therapy.

Conditions

Ventilation; Breathing; Atelectasis

Keywords

Incentive spirometry; EzPAP; Electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• Regional Distribution of Ventilation

  EIT will be used to measure change in regional distribution of ventilation during lung expansion therapy.

  2 months

Study Arms (2)

Volumetric Incentive Spirometry

ACTIVE COMPARATOR

Incentive Spirometry

Device: Volumetric Incentive Spirometry

EzPAP® POSITIVE AIRWAY PRESSURE

EXPERIMENTAL

EzPAP

Device: EzPAP® POSITIVE AIRWAY PRESSURE

Interventions

Volumetric Incentive Spirometry DEVICE

A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins. * Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences. * Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause. * The 10-breath cycle will be repeated three times with respiratory therapist coaching. * Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle. * Incentive Spirometry therapy and monitoring session will last about 15 minutes

Also known as: I.S.

Volumetric Incentive Spirometry

EzPAP® POSITIVE AIRWAY PRESSURE DEVICE

* A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only. * Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences. * Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause. * The 10-breath cycle will be repeated three times with respiratory therapist coaching. * Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle. * EzPAP® therapy and monitoring sessions will last about 15 minutes

Also known as: EzPAP®

EzPAP® POSITIVE AIRWAY PRESSURE

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy- not receiving in-patient medical care
• Documentation of written informed consent

You may not qualify if:

• Less than 18 or greater than 79 years of age
• Body mass index \> 50
• Excessive chest hair
• Inability to obtain written informed consent
• Inability to follow verbal instructions
• Pregnancy: self reported
• Uncontrolled body movements
• Inability to place EIT electrodes and belt in direct contact with skin where they are projected to come into contact
• Active implants (i.e., cardiac pacemaker, implantable cardioverter-defibrillator \[ICD\]), or when device compatibility is in doubt.)

Sponsors & Collaborators

• University of Virginia: lead
• Draeger Medical, Inc: collaborator

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases

Limitations and Caveats

This was a pilot study with a small enrollment sample. Study is underpowered to detect statistical significance if one exists between the primary group compared outcome measurement; Dorsal percent change in redistribution of ventilation.

Results Point of Contact

• Title: Daniel D. Rowley, MSc, RRT-ACCS, FAARC
• Organization: University of Virginia Health System

ddr8a@virginia.edu

434-465-7235

Study Officials

• Daniel D Rowley, MSc RRT-ACCS

  Pulmonary Diagnostics & Respiratory Therapy Servies, University of Virginia Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 20, 2017
• Study Start: March 6, 2017
• Primary Completion: April 21, 2017
• Study Completion: April 21, 2017
• Last Updated: June 14, 2018
• Results First Posted: June 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)