Chronic Obstructive Pulmonary DiseaseNCT00972868
A Novel Unidirectional Face Mask During NPPV in COPD Patients
A study testing A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask) in people with Chronic Obstructive Pulmonary Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 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
- Acute hypercapnic respiratory failure as a result of an acute exacerbation of COPD defined as PaCO2 > 50 mmHg, with or without hypoxia, and a respiratory rate of greater than 25/min with the use of accessory muscles of respiration or abdominal paradox;
- Requiring NPPV as assessed by the managing care team.
Who cannot join
- Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
- Patients who have claustrophobia and cannot wear the mask;
- Patients who are hemodynamically unstable;
- Patients who are disoriented and unable to cooperate with the study procedure;
- DNI or DNR status or patients in whom intubation is contraindicated;
- Patients who are currently intubated;
- Patients who recently (< 6months) had an MI or stroke;
- Pregnant woman; There will be no exclusion based on gender, race or ethnicity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients
The purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)
- Keywords
- Unidirectional mask, NPPV, COPD, respiratory physiology
- 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.
A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)Device
The regular face mask will be replaced with the study mask and patients will receive NPPV via the study mask for 30 min. The study mask insures a unidirectional breathing pattern, in through the nose and out through the mouth or in through the mouth and out through the nose. The sequence of these two breathing patterns with opposite flow direction will be chosen randomly. Each will be applied for 30 min with data collected during and at the end of the period.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Experimental | Thirty adult (> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV) Receives: Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in anatomical dead space and improvement in ventilatory efficiency
Measured: 30 minutes
Secondary outcomes (1)
Improvement of ventilation rate, tidal volume, end tidal CO2, arterial pH, PaCO2, and PaO2, SpO2, pulse rate, blood pressure and patient rating of comfort of each ventilatory pattern.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMar 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Inability to enrole subjucts.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yandong Jiang, Massachusetts General Hospital
- Investigators
- Yandong Jiang, MD, PhD, Principal investigator, Massachusetts General HospitalRobert Kacmarek, PhD, RRT, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972868
- Sponsor's protocol ID
- 2009P000057
- Status last verified
- Jan 2017
- First submitted
- 27 Aug 2009
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Unidirectional Face Mask During Noninvasive Positive Pressure Ventilation (NPPV) in Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT00972868
- Acronym / sponsor ID
- 2009P000057
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Unidirectional mask, NPPV, COPD, respiratory physiology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to enrole subjucts.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 9 Sep 2009 (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 purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Device: A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)Thirty adult (> 18 years of age) patients in acute hypercapnic respiratory failure resulting from COPD and requiring Noninvasive Positive Pressure Ventilation (NPPV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute hypercapnic respiratory failure as a result of an acute exacerbation of COPD defined as PaCO2 > 50 mmHg, with or without hypoxia, and a respiratory rate of greater than 25/min with the use of accessory muscles of respiration or abdominal paradox;
- Requiring NPPV as assessed by the managing care team.
Key exclusion criteria (8 listed)
- Patients with facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face;
- Patients who have claustrophobia and cannot wear the mask;
- Patients who are hemodynamically unstable;
- Patients who are disoriented and unable to cooperate with the study procedure;
- DNI or DNR status or patients in whom intubation is contraindicated;
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 |
|---|---|---|
| A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask)The regular face mask will be replaced with the study mask and patients will receive NPPV via the study mask for 30 min. The study mask insures a unidirectional breathing pattern, in through the nose and out through the mouth or in through the mouth and out through the nose. The sequence of these two breathing patterns with opposite flow direction will be chosen randomly. Each will be applied for 30 min with data collected during and at the end of the period. | Device | COPD |
Primary outcome
Reduction in anatomical dead space and improvement in ventilatory efficiency
Time frame: 30 minutes
1 secondary outcome
Improvement of ventilation rate, tidal volume, end tidal CO2, arterial pH, PaCO2, and PaO2, SpO2, pulse rate, blood pressure and patient rating of comfort of each ventilatory pattern.
Time frame: 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
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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.
Yandong Jiang, MD, PhD principal investigator
Massachusetts General Hospital
Robert Kacmarek, PhD, RRT study chair
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A unidirectional face mask (Modified 'Respironics PerformaTrak' Mask) in people with Chronic Obstructive Pulmonary Disease, run by Massachusetts General Hospital 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 8 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: withdrawn, as of the sponsor's last update on 16 Jan 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction in anatomical dead space and improvement in ventilatory efficiency (time frame: 30 minutes). 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 16 Jan 2017.