Comparing the Effectiveness of Lung Expansion Therapy in Adult Human Subjects
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

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.
    

Detailed description: 
      Investigators will use a convenience sampling scheme to identify potential study
      participants. Documentation of informed consent will be recorded. Electrical Impedance
      Tomography (EIT), which provides non-invasive and radiation free monitoring, will be used to
      monitor and measure regional distribution of ventilation during Incentive Spirometry (I.S.)
      and EzPAP® lung expansion therapy. The PulmoVista 500 EIT device has a reported high patient
      safety profile and poses minimal patient risk.

      The potential benefit for study participants will not be realized directly since the
      investigators' aim is to only monitor regional distribution of ventilation in response to
      I.S. or EzPAP® lung expansion therapy. While I.S. is considered to be a standard of
      post-operative care, there is low quality evidence documenting I.S. effectiveness in
      preventing pulmonary complications after upper abdominal surgery.

      Loss of dorsal lung volume (i.e., atelectasis) is an example of a post-operative pulmonary
      complication. EzPAP® is a lung expansion therapy that is used as an alternative to I.S. lung
      expansion therapy for increasing dorsal regional lung volume (i.e., Functional Residual
      Volume [FRC]) in an effort to prevent or reverse atelectasis. When expiratory positive airway
      pressures of 5, 10, and 15 cmH2O was administered to a small group of healthy human subjects,
      medical researchers identified that a positive pressure of 15 cmH2O was associated with the
      greatest FRC increase when compared to zero pressure and baseline FRC measurements.

      While study participants may not benefit directly from this study, investigators anticipate
      that important information will be gained from EIT monitoring of regional distribution of
      ventilation. Future upper abdominal post-operative surgical patients may benefit from this
      study's findings as investigators hope to advance clinical understanding associated with
      these therapies with use of EIT.

      Procedure set-up and device calibration will occur according to Draeger provided PulmoVista
      500 EIT training and operation manual instructions:

        -  Study participant preparation

             -  Investigators will assess the participant's thorax to ensure that the skin's
                surface is free of body fluids that may prevent or impede electrode contact. Skin
                surface will be wiped clean with a dry cloth if necessary.

             -  Investigators will select an electrode belt and respective patient cable sizes
                after measuring participant's chest circumference with paper measurement tape
                placed across the midclavicular line at intercostal space 4 -5. Electrode belt size
                will be selected according to chest circumference measurement.

             -  A patient cable of the same electrode belt size will be selected and connected to
                the electrode belt before connection to participant. Investigators will align and
                snap connect the patient cable snaps over the electrode belt studs by aligning
                respective snaps and studs in ascending numerical order from 1 to 16 .

             -  A light spray of water may be applied to the black electrode surface on the
                electrode belt before it is applied to participant if natural moisture from the
                skin does not result in sufficient conductivity between the skin and electrodes.

        -  Investigators will attach an electrode belt and reference electrode to participant while
           they are lying supine in bed. Participant's head of bed will be positioned at
           45-degrees.

             -  The electrode belt/cable combination will be attached around the thorax of each
                participant at the level of the 4th - 5th intercostal space, unless mammary tissue
                prevents this site of application. An alternative application site will be located
                immediately below the mammary tissue if necessary. Left to right belt orientation
                will be maintained with color coded patient cable ports signifying left and right
                side.

             -  Investigators will snap the electrode belt closed after verifying proper belt
                position. The belt's black electrodes should have close contact with the study
                participant's skin at this point.

             -  An adhesive ECG electrode will be place on the study participant's right upper
                abdominal quadrant and then the patient cable reference electrode snap will be
                attached to the ECG electrode.

             -  The patient cable will then be connected to the EIT monitoring device via a color
                coded trunk cable orientation that aligns with the patient cable left and right
                orientation

        -  EIT device calibration and signal check

             -  Investigators will initiate a PulmonVista 500 EIT monitoring device calibration
                each day prior to performing new study participant end-expiratory lung impedance
                measurements.

             -  A skin-electrode signal check will be performed to ensure that a minimum of 15 of
                16 electrodes have sufficient contact with the participant's skin surface and
                signal quality is stable. Investigators will use the following status display and
                explanation to determine adequacy of electrode contact and signal quality.

        -  Monitoring sessions and Lung Expansion Therapy procedure

             -  Monitoring will be initiated after investigators perform PulmoVista 500 EIT device
                setup and calibration prior to one of the three scheduled lung expansion therapy
                sessions on day 1, 3, and 5 (if not discharged from hospital) after surgery.

             -  Approximate monitoring/measurement duration is 15-minutes.

        -  Lung expansion therapies will occur as follows:

             -  Participants will be positioned supine in bed or bedside chair with head of bed or
                bedside chair positioned at 45-degrees.

      Incentive Spirometry Procedure Group:

        -  A respiratory therapist will provide instruction on Incentive Spirometry procedure
           performance before supervised therapy and monitoring begins.

        -  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.

        -  Each Incentive Spirometry therapy session will last about 15 minutes three times per
           day.

        -  EIT monitoring and deep breathing measurements will occur during one of the three
           scheduled Incentive Spirometry sessions on day 1, 3, and 5 (if not discharged from
           hospital) after surgery.

      EzPAP® Positive Airway Pressure Group:

        -  A respiratory therapist will provide instruction on EzPAP® procedure performance before
           supervised therapy and monitoring begins.

        -  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.

        -  Each TID EzPAP® therapy sessions will last about 15 minutes three times per day.

        -  EIT monitoring and deep breathing measurements will occur during one of the three
           scheduled Incentive Spirometry sessions on day 1, 3, and 5 (if not discharged from
           hospital) after surgery.

           • PulmoVista set-up and monitoring sessions will be coordinated in collaboration with
           each participant's bedside nurse and a respiratory therapist. Initial setup and
           monitoring commitment time is approximately 15 - 20 minutes.

        -  Electrical Impedance Tomography lung monitoring and measurements will occur during one
           of three scheduled EzPAP® therapies on day 1, 3, and 5 (if not discharged from hospital)
           after surgery. Participants will continue to receive respective lung expansion therapy
           as ordered three times per day, but without EIT monitoring.

           • Regional distribution of ventilation information will be displayed on the PulmoVista
           500 device's main monitoring screen during lung expansion therapy. Clinical staff
           administering therapy and participants will be blinded from information displayed on the
           screen's monitor in an effort to reduce performance bias.

        -  Once lung expansion therapy session has ended, investigators will detach trunk cables
           from electrode cables, detach reference electrode snap from adhesive ECG electrode,
           unclamp the electrode belt, and then remove belt from the participant.

        -  Investigators will inspect the electrode belt contact area to assess for evidence of
           skin irritation or bruising. Participant's physician will be notified of any significant
           findings.

           • Displaying changes

        -  Once the PulmoVista 500 EIT device is removed from participant's room, the investigator
           will change from main screen view to Display change view. Regional distribution of
           ventilation information displayed on the PulmoVista 500 EIT device's screen will be used
           to record pre and post lung expansion therapy end-expiratory lung impedance changes.

        -  PulmoVista 500 EIT device will be removed participant's room and returned to a storage
           location outside of patient care areas.

             -  Following each EIT to participant interface disconnect, an alcohol, aldehyde, or
                quaternary ammonium based compound will be soaked on a wipe cloth to disinfect the
                surfaces of the patient cable, electrode belt, trunk cable, and EIT unit.

             -  Participant's head of bed will be returned to original position or to an elevation
                that is preferred by the participant after therapy and monitoring session is
                complete.

             -  Participant will continue with assigned lung expansion therapy as scheduled.
    

Intervention name(s): Incentive Spirometry; EzPAP® Positive Airway Pressure
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: electrical impedance tomography; incentive spirometry; EzPAP; lung volume; atelectasis; positive airway pressure; pulmonary complication; abdominal surgery; end-expiratory lung volume