AnesthesiaNCT03214497
Protector™ Versus Supreme® Laryngeal Mask Airway
A study testing Protector and Supreme in people with Anesthesia, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The goal of this study is to compare the oropharyngeal leak pressure of the Protector Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Protector and Supreme
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jul 2017to 28 Nov 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-75
- ASA 1-3
- Operation on limbs
- written informed consent
Who cannot join
- known difficult airway
- anatomical abnormalities on airway, Larynx, oesophagus, stomach
- not fastened
- high aspiration risk
- patients with contraindication of laryngeal mask
- BMI >35 kg/m2
Show all 11Show fewer
- patients with disease which impairs accurate Investigation of patient
- cardiovascular risk factors
- COPD
- acute disease where anaesthesia is in doubt
- no written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Trial of the Protector™ Versus the Supreme® Laryngeal Mask Airway
The goal of this study is to compare the oropharyngeal leak pressure of the Protector Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.
Read the detailed description
The OLP as the primary outcome measurement will be evaluated after insertion of the LMA in each group. We hypothesize that there will be a difference of 4 cm H2O between the 2 masks, because of the different material and slightly different form of the masks. Secondary outcomes will be measured after insertion of the LMA as by protocol. Finally postoperative airway morbidity will be evaluated 3 hours after removal of the LMA.
- Conditions
- Anesthesia
- Being tested
- Protector, Supreme
- Keywords
- laryngeal mask, Supreme, Protector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtectorDevice
All patients which are assigned to the Protector are studied with this laryngeal mask
SupremeDevice
All patients which are assigned to the Supreme are studied with this laryngeal mask
| Study group | Role | What they receive |
|---|---|---|
| Protector group | Active comparator | All patients collocated randomly to the Protector Group Primary and secondary outcome Parameters are studied Receives: Device: Protector |
| Supreme group | Placebo comparator | All patients collocated randomly to the Supreme Group, Primary and secondary outcome Parameters are studied Receives: Device: Supreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
OLP
oropharyngeal leak pressure
Measured: 5 minutes
Secondary outcomes (9)
insertion
insertion of LMA
Measured: 5 minutes
time of insertion
time of Insertion of LMA
Measured: 5 minutes
Brimacombe score
Brimacombe score
Measured: 5 minutes
respiratory pressure
maximum respiratory pressure for adequate ventilation
Measured: 5 minutes
suctioning catheter
number needed of insertion of suctioning catheter
Measured: 5 minutes
suctioning fluids
ml suctioned from suctioning catheter
Measured: 5 minutes
CO2
endtidal CO2
Measured: 5 minutes
blood staining
visible blood staining after removal of the laryngeal mask
Measured: 5 minutes
airway morbidity
assess sore throat, neck pain
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start12 Jul 2017
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berthold Moser, MD, MBA, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214497
- Sponsor's protocol ID
- Schulthess_Anä_11
- Status last verified
- Nov 2017
- First submitted
- 28 Jun 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Trial of the Protector™ Versus the Supreme® Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT03214497
- Acronym / sponsor ID
- Schulthess_Anä_11
- Conditions
- Anesthesia
- Keywords
- laryngeal mask, Supreme, Protector
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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 goal of this study is to compare the oropharyngeal leak pressure of the Protector Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.
Detailed description
The OLP as the primary outcome measurement will be evaluated after insertion of the LMA in each group. We hypothesize that there will be a difference of 4 cm H2O between the 2 masks, because of the different material and slightly different form of the masks. Secondary outcomes will be measured after insertion of the LMA as by protocol. Finally postoperative airway morbidity will be evaluated 3 hours after removal of the LMA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protector group | Active comparator | Device: ProtectorAll patients collocated randomly to the Protector Group Primary and secondary outcome Parameters are studied |
| Supreme group | Placebo comparator | Device: SupremeAll patients collocated randomly to the Supreme Group, Primary and secondary outcome Parameters are studied |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-75
- ASA 1-3
- Operation on limbs
- written informed consent
Key exclusion criteria (11 listed)
- known difficult airway
- anatomical abnormalities on airway, Larynx, oesophagus, stomach
- not fastened
- high aspiration risk
- patients with contraindication of laryngeal mask
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 |
|---|---|---|
| ProtectorAll patients which are assigned to the Protector are studied with this laryngeal mask | Device | Protector group |
| SupremeAll patients which are assigned to the Supreme are studied with this laryngeal mask | Device | Supreme group |
Primary outcome
OLP
Time frame: 5 minutes
oropharyngeal leak pressure
9 secondary outcomes
insertion
Time frame: 5 minutes
time of insertion
Time frame: 5 minutes
Brimacombe score
Time frame: 5 minutes
respiratory pressure
Time frame: 5 minutes
suctioning catheter
Time frame: 5 minutes
suctioning fluids
Time frame: 5 minutes
CO2
Time frame: 5 minutes
blood staining
Time frame: 5 minutes
airway morbidity
Time frame: 3 hours
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 2 Dec 2017.
- Individual participant dataSharing planned: Yes
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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.
Berthold Moser, MD, MBA principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protector and Supreme in people with Anesthesia, run by Schulthess Klinik at 1 site in Switzerland.
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 11 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 2 Dec 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
OLP (time frame: 5 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 2 Dec 2017.