Comparing the Effectiveness of Lung Expansion Therapy in Adult Human Subjects

Completed · Not applicable

Conditions studied: Atelectasis

In brief

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.

Key facts

Study ID

NCT02892773

Run by

University of Virginia

People needed

112

Starts

2017-01-01

Expected to finish

2018-11-12

Last updated by the study team

2018-11-19

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Human subjects 18 - 79 years of age
• Post-operative upper abdominal surgery
• Examples:
• Laparotomy
• Biliodigestive anastomosis
• Cholecystectomy
• Enterectomy
• Esophagectomy
• Gastrectomy
• Hepatectomy
• Pancreatectomy
• Unassisted spontaneous breathing
• Attending surgeon's approval
• Anticipated post-operative hospital length of stay greater than 3 days
• Documentation of written informed consent
• Ability to sign consent

You may not qualify if…

• Less than 18 or greater than 79 years of age
• Anticipated post-operative hospital length of stay less than 3 days
• Body mass index > 50
• Excessive chest hair
• Inability to obtain written informed consent
• Inability to follow verbal instructions
• Pregnancy-self reported
• uncontrolled body movements
• Insertion of an artificial airway
• Hemodynamic instability
• Loss of skin integrity at site where EIT electrodes and belt are projected to come into contact (i.e., chest burns, open wounds/lesions, etc…).
• Chest tube or dressings that prohibit placement of EIT electrodes and belt
• Active implants (i.e., cardiac pacemaker, implantable cardioverter-defibrillator [ICD]), diaphragm pacer, or when device compatibility is in doubt.)
• Invasive or non-invasive mechanical ventilation support
• Unstable spinal lesions or fractures
• Untreated pneumothorax
• Active hemoptysis
• Esophageal surgery
• Decision to withhold life-sustaining treatment

Where it is running

• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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