Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy
Condition: Ventilation; Breathing; Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

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.
    

Detailed description: 
      Investigators will use a convenience sampling scheme to identify potential study
      participants. Documentation of informed consent will be recorded. Electrical Impedance
      Tomography (Pulmovista 500; Draeger, Lubeck, Germany), which provides non-invasive and
      radiation free monitoring, will be used to monitor and measure regional distribution of
      ventilation during I.S and EzPAP® lung expansion therapy.

      Recruitment email will be will be sent to University of Virginia Medical Center employees who
      represent the target study population. A university of Virginia email distribution list will
      be used to mass email respiratory therapy and nursing staff working in adult ICU and surgical
      acute care patient wards. Word of mouth will also be used to heighten awareness about this
      study.

      A computer generated random numbers generator will be used to randomly assign study subjects
      into an I.S. or EzPAP® lung expansion therapy group after documentation of informed consent
      has been recorded. Randomization masking/blinding will not occur in this study. The lung
      expansion therapy medical device designs and their respective operational differences are
      impossible to conceal.

      Procedure set-up and device calibration will occur according to Draeger provided PulmoVista
      500 (Draeger; Lubeck, Germany) EIT training and operation manual:

        -  Study participant preparation

             -  Investigator 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 a chest circumference measurement that aligns best to the
                manufacturer's recommended belt size identified in a belt selection table.

             -  A patient cable of the same electrode belt size will be selected and connected to
                the electrode belt before connection to study participants. Investigator 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 warm tap water will be applied to the electrode surface on the
                electrode belt before it is applied to study participants to optimize conductivity
                between the skin and electrodes.

        -  Attaching electrode belt and reference electrode to study participant while they are
           positioned at 45-degrees sitting in a reclining chair.

             -  The electrode belt/cable combination will be attached around the thorax of each
                study 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.

             -  An investigator 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 (PulmoVista
                500, Lubeck, Germany) via a color coded trunk cable orientation that aligns with
                the patient cable left and right orientation.

        -  EIT device calibration and signal check

             -  Investigator will initiate a PulmonVista 500 EIT monitoring device calibration each
                day prior to performing new study participant EELI 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.

        -  Monitoring sessions and Lung Expansion Therapy procedure

             -  Monitoring will be initiated after researcher performs PulmoVista 500 EIT device
                (Draeger; Lubeck, Germany) setup and calibration.

             -  Approximate monitoring/measurement duration is 15-minutes.

      INCENTIVE SPIROMETRY GROUP

      - A study investigator will instruct the study participant to strive for an inspiratory
      capacity volume target as determined by the I.S. device's predicted volume nomogram table.

      Incentive Spirometry procedure 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.

      EzPAP® POSITIVE AIRWAY PRESSURE GROUP

        -  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.

      REGIONAL DISTRIBUTION OF VENTILATION MONITORING:

        -  PulmoVista monitoring and lung expansion therapy will occur only one time as described
           above.

        -  Global and regional distribution of ventilation data will be displayed on the PulmoVista
           500 device's main monitoring screen during lung expansion therapy, but study
           investigator staff administering therapy and study participants will be blinded from
           information displayed on the screen's monitor during therapy session in an effort to
           reduce performance bias.

             -  Once lung expansion therapy session has ended, the investigator 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 study
                participant. Subject participation in this study is considered complete at this
                time.

             -  Inspection of electrode belt contact area will be performed to assess for evidence
                of skin irritation or bruising. Study participant will be notified by study
                investigator at the time of skin assessment if significant skin irritation or
                bruising is present. Finding will be recorded by study investigator.

        -  Electrode belt, patient cable, and PulmoVista 500 EIT device (Draeger; Lubeck, Germany)
           will be removed study participant's room and returned to a storage location outside of
           patient care areas.

        -  Following each EIT to subject 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.
    

Intervention name(s): Volumetric Incentive Spirometry; EzPAP® POSITIVE AIRWAY PRESSURE
Intervention type(s): Device; Device
Intervention description(s): 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; 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
Other intervention name(s): I.S.; EzPAP®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Incentive spirometry; EzPAP; Electrical impedance tomography