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Protector™ Versus Supreme® Laryngeal Mask Airway

Prospective Randomised Trial of the Protector™ Versus the Supreme® Laryngeal Mask Airway

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03214497
Enrollment
96
Registered
2017-07-11
Start date
2017-07-12
Completion date
2017-11-28
Last updated
2017-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

laryngeal mask, Supreme, Protector

Brief 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.

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.

Interventions

DEVICEProtector

All patients which are assigned to the Protector are studied with this laryngeal mask

DEVICESupreme

All patients which are assigned to the Supreme are studied with this laryngeal mask

Sponsors

Schulthess Klinik
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age between 18-75 * ASA 1-3 * Operation on limbs * written informed consent

Exclusion criteria

* 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 * patients with disease which impairs accurate Investigation of patient * cardiovascular risk factors * COPD * acute disease where anaesthesia is in doubt * no written consent

Design outcomes

Primary

MeasureTime frameDescription
OLP5 minutesoropharyngeal leak pressure

Secondary

MeasureTime frameDescription
CO25 minutesendtidal CO2
blood staining5 minutesvisible blood staining after removal of the laryngeal mask
airway morbidity3 hoursassess sore throat, neck pain
insertion5 minutesinsertion of LMA
suctioning fluids5 minutesml suctioned from suctioning catheter
Brimacombe score5 minutesBrimacombe score
respiratory pressure5 minutesmaximum respiratory pressure for adequate ventilation
suctioning catheter5 minutesnumber needed of insertion of suctioning catheter
time of insertion5 minutestime of Insertion of LMA

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026