Comparing the Effectiveness of Lung Expansion Therapy in Adult Human Subjects

Summary

The purpose of this study is to better understand how air is spread throughout study participants' lungs after abdominal surgery by comparing two lung inflation treatments:

1. Incentive Spirometry (I.S.) lung expansion therapy
2. EzPAP® lung expansion therapy.

Lung expansion therapy is routinely used after upper abdominal surgery. Taking deep breaths after surgery helps lungs to stay inflated. At the University of Virginia, it is at the physician's discretion as to which treatment will be used to help with deep breathing lung inflation therapy after surgery. The investigators would like to know which of the lung inflation therapies is better at helping inflate participants' lungs.

The investigators will be using a device called Electrical Impedance Tomography (EIT) to measure how effectively air spreads in participants' lungs. This device is not currently approved by the Food and Drug Administration (FDA) for the purpose used in this study, and therefore, it is considered investigational.

Investigators are inviting eligible participants to consider participating in this study because doctors order Incentive Spirometry as a standard of care following upper abdominal surgery. Information gained from monitoring how air is spread throughout participants' lungs will help investigators to determine if there is a clinical difference and benefit when comparing Incentive Spirometry and EzPAP lung expansion therapies.

Conditions

• Atelectasis

Interventions

DEVICE

Incentive Spirometry

A respiratory therapist will provide instruction on Incentive Spirometry (I.S.) procedure performance before supervised therapy and monitoring begins. * Study participants will be asked to take 10 deep breaths through the I.S.'s mouthpiece, followed by a 60 second pause. * The 10-breath cycle will be repeated 3 times per therapy session. * Each I.S. therapy session will last about 15 minutes, 3 times per day. * Lung monitoring and deep breathing measurements will occur during a scheduled I.S. sessions on day 1, 3, and 5 after surgery.

DEVICE

EzPAP® Positive Airway Pressure

A respiratory therapist will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. * 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 3 times. * Each EzPAP® therapy sessions will last about 15 minutes, 3 times per day. * Lung monitoring will occur during a scheduled EzPAP® sessions on day 1, 3, and 5 after surgery.

Sponsors & Collaborators

• Draeger Medical, Inc

  collaborator INDUSTRY

• University of Virginia

  lead OTHER

Principal Investigators

• Daniel D Rowley, MSc RRT-ACCS · Pulmonary Diagnostics & Respiratory Therapy Services, University of Virginia Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2018-11-12

Completion

2018-11-12

Countries

• United States

Study Locations