Atelectasis Clinical Trial
Official title:
A Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy in Healthy Adult Human Subjects
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.
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.
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