VentilationNCT03083379
Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy
A study testing Volumetric Incentive Spirometry and EzPAP® POSITIVE AIRWAY PRESSURE in people with Ventilation and Breathing, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation, Breathing, Atelectasis
- What is being tested?
- Volumetric Incentive Spirometry and EzPAP® POSITIVE AIRWAY PRESSURE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 21 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy- not receiving in-patient medical care
- Documentation of written informed consent
Who cannot join
- Less than 18 or greater than 79 years of age
- Body mass index > 50
- Excessive chest hair
- Inability to obtain written informed consent
- Inability to follow verbal instructions
- Pregnancy: self reported
Show all 9Show fewer
- Uncontrolled body movements
- Inability to place EIT electrodes and belt in direct contact with skin where they are projected to come into contact
- Active implants (i.e., cardiac pacemaker, implantable cardioverter-defibrillator [ICD]), or when device compatibility is in doubt.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Medical Center
Charlottesville, Virginia, 22903
About this study
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.
Read the 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.
- Conditions
- Ventilation, Breathing, Atelectasis
- Being tested
- Volumetric Incentive Spirometry, EzPAP® POSITIVE AIRWAY PRESSURE
- Keywords
- Incentive spirometry, EzPAP, Electrical impedance tomography
- Medical subject headings
- Respiratory Aspiration, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric Incentive SpirometryDevice
Also called I.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
EzPAP® POSITIVE AIRWAY PRESSUREDevice
Also called EzPAP®
- 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
| Study group | Role | What they receive |
|---|---|---|
| Volumetric Incentive Spirometry | Active comparator | Incentive Spirometry Receives: Device: Volumetric Incentive Spirometry |
| EzPAP® POSITIVE AIRWAY PRESSURE | Experimental | EzPAP Receives: Device: EzPAP® POSITIVE AIRWAY PRESSURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Distribution of Ventilation
EIT will be used to measure change in regional distribution of ventilation during lung expansion therapy.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start6 Mar 2017
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Draeger Medical, Inc
- Responsible party
- Principal investigator, Daniel D Rowley, University of Virginia
- Investigators
- Daniel D Rowley, MSc RRT-ACCS, Principal investigator, Pulmonary Diagnostics & Respiratory Therapy Servies, University of Virginia Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083379
- Sponsor's protocol ID
- 19661
- Status last verified
- Jun 2018
- First submitted
- 6 Mar 2017
- Last updated
- 14 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy in Healthy Adult Human Subjects
- ClinicalTrials.gov ID
- NCT03083379
- Acronym / sponsor ID
- 19661
- Conditions
- Ventilation, Breathing, Atelectasis
- Keywords
- Incentive spirometry, EzPAP, Electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Draeger Medical, Inc
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Posted 14 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volumetric Incentive Spirometry | Active comparator | Device: Volumetric Incentive SpirometryIncentive Spirometry |
| EzPAP® POSITIVE AIRWAY PRESSURE | Experimental | Device: EzPAP® POSITIVE AIRWAY PRESSUREEzPAP |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy- not receiving in-patient medical care
- Documentation of written informed consent
Key exclusion criteria (9 listed)
- Less than 18 or greater than 79 years of age
- Body mass index > 50
- Excessive chest hair
- Inability to obtain written informed consent
- Inability to follow verbal instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric Incentive SpirometryAlso: I.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 | Device | Volumetric Incentive Spirometry |
| EzPAP® POSITIVE AIRWAY PRESSUREAlso: EzPAP®* 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 | Device | EzPAP® POSITIVE AIRWAY PRESSURE |
Primary outcome
Regional Distribution of Ventilation
Time frame: 2 months
EIT will be used to measure change in regional distribution of ventilation during lung expansion therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel D Rowley, MSc RRT-ACCS principal investigator
Pulmonary Diagnostics & Respiratory Therapy Servies, University of Virginia Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric Incentive Spirometry and EzPAP® POSITIVE AIRWAY PRESSURE in people with Ventilation and Breathing, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Distribution of Ventilation (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018; AzTrials last refreshed its copy on 31 Oct 2026.