AnesthesiaEMAFNCT02778984
Facial Mask Tightness: A Comparative Study
A study testing QuadraLite masks and standard mask in people with Anesthesia, run by University Hospital, Limoges at 1 site in France.
Trial summary
A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. Most tight masks are actually sold but they have never been compared in studies. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- QuadraLite masks and standard mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Dec 2018
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- edentulous patients
- age > 55 years
Who cannot join
- pregnancy or breast-feeding, patients on tutelage or guardianship
- patient unable to understand the protocol
- anesthesia in emergency or with full stomach
Trial locations and contacts
1 site in 1 country.
About this study
A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. Most tight masks are actually sold but they have never been compared in studies. The aim of this study is to compare air leaks with standard facial mask and QuadraLite masks during preoxygenation and induction of anesthesia.
- Conditions
- Anesthesia
- Being tested
- QuadraLite masks, standard mask
- Keywords
- Anesthesia, facial mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuadraLite masksDevice
The intervention is identical in the two group
standard maskOther
| Study group | Role | What they receive |
|---|---|---|
| standard face masks | Active comparator | The standard mask is used in usual care Receives: Other: standard mask |
| QuadraLite face masks | Experimental | This study will compare tightness of 2 face masks during preoxygenation and after induction of anesthesia with propofol, sufentanil and rocuronium. During preoxygenation, a 10 l.min-1 fresh gas flow and 8 cm H2O PEEP will be applied. After induction of anesthesia, patients will receive pressure-controlled ventilation (fresh gaz flow 3 L.min-1, pressure set to obtain a 7 ml.kg-1 ideal body weight, 10 cpm, peep 5 cm H2O). Receives: Device: QuadraLite masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778984
- Sponsor's protocol ID
- I15035
- Acronym
- EMAF
- Status last verified
- May 2017
- First submitted
- 13 May 2016
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Mask Tightness: A Comparative Study
- ClinicalTrials.gov ID
- NCT02778984
- Acronym / sponsor ID
- EMAF / I15035
- Conditions
- Anesthesia
- Keywords
- Anesthesia, facial mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 May 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.
A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. Most tight masks are actually sold but they have never been compared in studies. The aim of this study is to compare air leaks with standard facial mask and QuadraLite masks during preoxygenation and induction of anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard face masks | Active comparator | Other: standard maskThe standard mask is used in usual care |
| QuadraLite face masks | Experimental | Device: QuadraLite masksThis study will compare tightness of 2 face masks during preoxygenation and after induction of anesthesia with propofol, sufentanil and rocuronium. During preoxygenation, a 10 l.min-1 fresh gas flow and 8 cm H2O PEEP will be applied. After induction of anesthesia, patients will receive pressure-controlled ventilation (fresh gaz flow 3 L.min-1, pressure set to obtain a 7 ml.kg-1 ideal body weight, 10 cpm, peep 5 cm H2O). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- edentulous patients
- age > 55 years
Key exclusion criteria (3 listed)
- pregnancy or breast-feeding, patients on tutelage or guardianship
- patient unable to understand the protocol
- anesthesia in emergency or with full stomach
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 |
|---|---|---|
| QuadraLite masksThe intervention is identical in the two group | Device | QuadraLite face masks |
| standard mask | Other | standard face masks |
Primary outcome
significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask
Time frame: 10 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 11 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuadraLite masks and standard mask in people with Anesthesia, run by University Hospital, Limoges at 1 site in France.
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 3 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 11 Jan 2019. 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 France. 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?
significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask (time frame: 10 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 11 Jan 2019.