Chronic Obstructive Lung DiseaseNCT01596023
Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients
A study testing Breathe NIOV Ventilator in people with Chronic Obstructive Lung Disease, run by Breathe Technologies, Inc. at 1 site in United States.
Trial summary
The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Lung Disease
- What is being tested?
- Breathe NIOV Ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is >18 years of age at time of consent.
- Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 < 50% predicted and FEV1/FVC ratio < 70% predicted.
- Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration
Who cannot join
- Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
- Subject has respiratory rate at rest > 28/min
- Subject requires > 5 L/min nasal O2/min to maintain O2sat > 90%
- Subject has severe dyspnea at rest
- Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
- Subject has history of pneumothorax secondary to lung bullae.
Show all 9Show fewer
- Subject is too cognitively impaired to give subjective ratings for visual analog scale
- Subject has sensitivity or an allergy to lidocaine
- Subject has known history of oxygen intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients
The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.
- Conditions
- Chronic Obstructive Lung Disease
- Being tested
- Breathe NIOV Ventilator
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe NIOV VentilatorDevice
Portable, non invasive open ventilation system
| Study group | Role | What they receive |
|---|---|---|
| NIOV Ventilator | Experimental | Breathe NIOV Ventilator under various volume augmentation settings Receives: Device: Breathe NIOV Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System
Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration
Measured: 10 min
Secondary outcomes (1)
Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min
Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min)
Measured: 10 Min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breathe Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center
- Responsible party
- Sponsor
- Investigators
- Nicholas Hill, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596023
- Sponsor's protocol ID
- CP-00-0033
- Status last verified
- Jan 2014
- First submitted
- 8 May 2012
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients
- ClinicalTrials.gov ID
- NCT01596023
- Acronym / sponsor ID
- CP-00-0033
- Conditions
- Chronic Obstructive Lung Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Breathe Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIOV Ventilator | Experimental | Device: Breathe NIOV VentilatorBreathe NIOV Ventilator under various volume augmentation settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is >18 years of age at time of consent.
- Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 < 50% predicted and FEV1/FVC ratio < 70% predicted.
- Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration
Key exclusion criteria (9 listed)
- Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
- Subject has respiratory rate at rest > 28/min
- Subject requires > 5 L/min nasal O2/min to maintain O2sat > 90%
- Subject has severe dyspnea at rest
- Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
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 |
|---|---|---|
| Breathe NIOV VentilatorPortable, non invasive open ventilation system | Device | NIOV Ventilator |
Primary outcome
Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System
Time frame: 10 min
Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration
1 secondary outcome
Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min
Time frame: 10 Min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
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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.
Nicholas Hill, MD principal investigator
Tufts 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 Breathe NIOV Ventilator in people with Chronic Obstructive Lung Disease, run by Breathe Technologies, Inc. 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 3 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 15 Jan 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System (time frame: 10 min). 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 15 Jan 2014.