ApneaNCT02828280
NuMask Versus Traditional Mask Ventilation During Routine Care
An observational study of Apnea, run by Derek Sakata.
Trial summary
The direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Apnea
- What is being tested?
- NuMask and Traditional mask
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jan 2014
- Phase
- Observational
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients selected will be undergoing elective surgery at the University of Utah
Who may be able to join
- 44 adults total
- ASA status I-III
- aged 18-64
- elective surgery at the University of Utah under general anesthesia
- Bearded, BMI >35 or edentulous
Who cannot join
- ASA IV or higher
- Oropharyngeal or facial pathology
- Risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease)
- Known and/or documented difficulty placing an endotracheal tube in the past
- Limited neck extension or flexion
- Personal or familial history of malignant hyperthermia
- Known or predicted severe respiratory disease or compromise
- Pregnancy
About this study
Official title: A Comparison of Controlled Ventilation With the NuMask vs. Traditional Mask Ventilation.
The direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. The researchers believe that mean tidal volumes obtained by experienced providers when manually ventilating anesthetized patients with the NuMask device will be larger than when using the traditional bag-valve-mask.
- Conditions
- Apnea
- Being tested
- NuMask, Traditional mask
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuMaskDevice
The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.
Traditional maskDevice
A traditional air inflated facemark used to ventilate patients
| Study group | Role | What they receive |
|---|---|---|
| NuMask | Pt's randomized to Numask first will be ventilated for 10 breaths with the NuMask device first, followed by 10 breaths with the traditional face mask Receives: Device: NuMask; Device: Traditional mask | |
| Traditional mask | patients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask Receives: Device: NuMask; Device: Traditional mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal Volume comparison
Tidal volumes delivered between the two devices will be compared
Measured: 2 minutes (one minute for NuMask, one minute for traditional mask)
Secondary outcomes (1)
Ease of use
Provider will rate each device for ease of use on a 1-5 scale with 1 being easy and 5 being difficult.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMay 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derek Sakata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Derek Sakata, University of Utah
- Investigators
- Derek Sakata, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828280
- Sponsor's protocol ID
- IRB_00042299
- Status last verified
- May 2017
- First submitted
- 17 Jun 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.
PubMed 2339799
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Controlled Ventilation With the NuMask vs. Traditional Mask Ventilation.
- ClinicalTrials.gov ID
- NCT02828280
- Acronym / sponsor ID
- IRB_00042299
- Conditions
- Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Derek SakataUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Jul 2016 (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 direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. The researchers believe that mean tidal volumes obtained by experienced providers when manually ventilating anesthetized patients with the NuMask device will be larger than when using the traditional bag-valve-mask.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuMask | – | Device: NuMask, Device: Traditional maskPt's randomized to Numask first will be ventilated for 10 breaths with the NuMask device first, followed by 10 breaths with the traditional face mask |
| Traditional mask | – | Device: NuMask, Device: Traditional maskpatients randomized to traditional mask first will receive 10 breaths by traditional mask, followed by 10 breaths with NuMask |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients selected will be undergoing elective surgery at the University of Utah
Key inclusion criteria (5 listed)
- 44 adults total
- ASA status I-III
- aged 18-64
- elective surgery at the University of Utah under general anesthesia
- Bearded, BMI >35 or edentulous
Key exclusion criteria (8 listed)
- ASA IV or higher
- Oropharyngeal or facial pathology
- Risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease)
- Known and/or documented difficulty placing an endotracheal tube in the past
- Limited neck extension or flexion
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 |
|---|---|---|
| NuMaskThe NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006. | Device | NuMask, Traditional mask |
| Traditional maskA traditional air inflated facemark used to ventilate patients | Device | NuMask, Traditional mask |
Primary outcome
Tidal Volume comparison
Time frame: 2 minutes (one minute for NuMask, one minute for traditional mask)
Tidal volumes delivered between the two devices will be compared
1 secondary outcome
Ease of use
Time frame: 2 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 9 May 2017.
- Background: PubMed 2339799Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.
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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.
Derek Sakata, MD principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, run by Derek Sakata.
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 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: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Tidal Volume comparison (time frame: 2 minutes (one minute for NuMask, one minute for traditional mask)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828280, which also lists 1 linked publication.
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 9 May 2017.