Respiratory InsufficiencyNCT00817804
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
A study testing Use of the V60 Mask 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 7 to 18 years
- Conditions the study is for
- Respiratory Insufficiency, Respiratory Failure
- What is being tested?
- Use of the V60 Mask Ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Mar 2009
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age > 7 years and < 18 years
- Weight > 20 kg (44 lbs)
- Respiratory failure or respiratory insufficiency
- Ability to cooperate with the investigators
- Designated adult able to provide Informed Consent
Who cannot join
- An endotracheal tube or tracheostomy in place
- Hemodynamically 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
- PaO2 < 50 mmHg on present settings
- Designee unable or unwilling to provide Informed Consent
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 Pediatric 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
This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Being tested
- Use of the V60 Mask 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.
Use of the V60 Mask VentilatorDevice
Also called V60 is the Philips V60 Ventilator
The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.
| Study group | Role | What they receive |
|---|---|---|
| V60 then Conventional | Experimental | Study device first Receives: Device: Use of the V60 Mask Ventilator |
| Conventional then V60 | Experimental | Conventional device first Receives: Device: Use of the V60 Mask Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing Comfort
Comfort on visual analog scale 0 - 100, 0 is best
Measured: 30 minutes
Secondary outcomes (5)
Saturation of Arterial Oxygen
Measured: 30 minutes
Respiratory Rate
Breathing rate in breaths per minute
Measured: 30 minutes
Minute Ventilation
Liters per minute that the patient breathes
Measured: 30 minutes
Heart Rate
Beats per minute that the patient's heart is beating
Measured: 30 minutes
Blood Pressure
Systolic and diastolic blood pressure
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 posted6 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
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 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
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respironics, California, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Mink, MD, Principal investigator, University of Manitoba, Winnipeg, Manitoba, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817804
- Sponsor's protocol ID
- V60-1050766VP v 2.3
- Status last verified
- Aug 2009
- First submitted
- 3 Jan 2009
- Last updated
- 19 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. 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 Pediatric Patients With Respiratory Failure or Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT00817804
- Acronym / sponsor ID
- V60-1050766VP v 2.3
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Keywords
- noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Respironics, California, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Posted 12 Aug 2009
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
This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V60 then Conventional | Experimental | Device: Use of the V60 Mask VentilatorStudy device first |
| Conventional then V60 | Experimental | Device: Use of the V60 Mask VentilatorConventional device first |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age > 7 years and < 18 years
- Weight > 20 kg (44 lbs)
- Respiratory failure or respiratory insufficiency
- Ability to cooperate with the investigators
- Designated adult able to provide Informed Consent
Key exclusion criteria (19 listed)
- An endotracheal tube or tracheostomy in place
- Hemodynamically 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 |
|---|---|---|
| Use of the V60 Mask VentilatorAlso: V60 is the Philips V60 VentilatorThe V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed. | Device | Conventional then V60, V60 then Conventional |
Primary outcome
Breathing Comfort
Time frame: 30 minutes
Comfort on visual analog scale 0 - 100, 0 is best
5 secondary outcomes
Saturation of Arterial Oxygen
Time frame: 30 minutes
Respiratory Rate
Time frame: 30 minutes
Minute Ventilation
Time frame: 30 minutes
Heart Rate
Time frame: 30 minutes
Blood Pressure
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Use of the V60 Mask 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 5 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 19 Aug 2009. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2009). 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?
Breathing Comfort (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 19 Aug 2009.