Respiratory InsufficiencyNCT00817297
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
A study testing noninvasive ventilator in people with Respiratory Insufficiency and Respiratory Failure, run by Respironics, California, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Insufficiency, Respiratory Failure
- What is being tested?
- noninvasive ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2009to 7 Apr 2009
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 85 years
- Weight > 20 kg (44 lbs)
- Respiratory failure or respiratory insufficiency
- Ability to cooperate with the investigators
Who cannot join
- An endotracheal tube or tracheostomy in place
- Hemodynamic instability
- Prolonged apnea
- Inability to maintain the airway
- A recent history of cardiac and or respiratory arrest
- Acute hemorrhage
Show all 19Show fewer
- Multiple organ system failure
- Undrained pneumothorax
- High risk for aspiration
- Metastatic or terminal cancer
- Do-not-resuscitate orders
- Inability to clear respiratory secretions
- Inability to fit a mask
- Facial surgery, trauma, or deformity
- Upper gastrointestinal or airway surgery
- Pregnancy
- Refractory delirium
- Inability or unwillingness to provide Informed Consent
- PaO2 < 50 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Adult Patients With Respiratory Failure or Respiratory Insufficiency
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
Read the detailed description
The primary objective of this study was to compare the performance (i.e., patient self-reported Comfort score) of the V60 device and a conventional noninvasive ventilator (patient's current ventilator). For the User Needs Assessment, the primary objective of the study was to validate the V60 to user needs. All patients were volunteers from the Respiratory Section of the Health Sciences Centre at the University of Manitoba. The study utilized a randomized 2-period cross-over study design to compare the V60 System to the patients' existing conventional noninvasive ventilator in different ventilation modes.
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Being tested
- noninvasive ventilator
- Keywords
- noninvasive ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive ventilatorDevice
Experimental V60 Mask noninvasive Ventilator for treating patients with COPD, then Comparator Conventional Mask noninvasive Ventilator for treating patients with COPD in crossover study design
| Study group | Role | What they receive |
|---|---|---|
| V60 Mask, Then Conventional Mask | Other | Experimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD Receives: Device: noninvasive ventilator |
| Conventional Mask, Then V60 Mask | Other | Comparator Conventional Mask noninvasive Ventilator for treating adult patients with COPD, then Experimental V60 Mask noninvasive Ventilator for treating adult patients with COPD. Receives: Device: noninvasive ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing comfort
Measured: 0, 15, and 30 minutes
Secondary outcomes (1)
Physiological variables
Measured: 0, 15, and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study start17 Jan 2009
- Primary completion3 Mar 2009
- Study completion7 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respironics, California, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Mink, MD, Principal investigator, University of Manitoba, Winnipeg, Manitoba, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817297
- Sponsor's protocol ID
- V60-1050767VP v 2.4
- Status last verified
- Apr 2017
- First submitted
- 3 Jan 2009
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Adult Patients With Respiratory Failure or Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT00817297
- Acronym / sponsor ID
- V60-1050767VP v 2.4
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Keywords
- noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Respironics, California, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2009 (actual)
- Primary completion
- 3 Mar 2009 (actual)
- Study completion
- 7 Apr 2009 (actual)
- First posted
- 6 Jan 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 compare a new noninvasive ventilator to existing ventilators already used for patient care.
Detailed description
The primary objective of this study was to compare the performance (i.e., patient self-reported Comfort score) of the V60 device and a conventional noninvasive ventilator (patient's current ventilator). For the User Needs Assessment, the primary objective of the study was to validate the V60 to user needs. All patients were volunteers from the Respiratory Section of the Health Sciences Centre at the University of Manitoba. The study utilized a randomized 2-period cross-over study design to compare the V60 System to the patients' existing conventional noninvasive ventilator in different ventilation modes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V60 Mask, Then Conventional Mask | Other | Device: noninvasive ventilatorExperimental V60 Mask Ventilator for treating adult patients with COPD, then Comparator Conventional Mask Ventilator for treating adult patients with COPD |
| Conventional Mask, Then V60 Mask | Other | Device: noninvasive ventilatorComparator Conventional Mask noninvasive Ventilator for treating adult patients with COPD, then Experimental V60 Mask noninvasive Ventilator for treating adult patients with COPD. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years and < 85 years
- Weight > 20 kg (44 lbs)
- Respiratory failure or respiratory insufficiency
- Ability to cooperate with the investigators
Key exclusion criteria (19 listed)
- An endotracheal tube or tracheostomy in place
- Hemodynamic instability
- Prolonged apnea
- Inability to maintain the airway
- A recent history of cardiac and or respiratory arrest
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 |
|---|---|---|
| noninvasive ventilatorExperimental V60 Mask noninvasive Ventilator for treating patients with COPD, then Comparator Conventional Mask noninvasive Ventilator for treating patients with COPD in crossover study design | Device | Conventional Mask, Then V60 Mask, V60 Mask, Then Conventional Mask |
Primary outcome
Breathing comfort
Time frame: 0, 15, and 30 minutes
1 secondary outcome
Physiological variables
Time frame: 0, 15, and 30 minutes
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 17 Nov 2017.
- 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.
Steven Mink, MD principal investigator
University of Manitoba, Winnipeg, Manitoba, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive ventilator in people with Respiratory Insufficiency and Respiratory Failure, run by Respironics, California, Inc. at 1 site in Canada.
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 4 inclusion and 19 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 17 Nov 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 Canada. 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?
Breathing comfort (time frame: 0, 15, and 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 17 Nov 2017.