Protector™ Versus Supreme® Laryngeal Mask Airway

Schulthess Klinik

Status: Completed

Conditions: Anesthesia

Treatments: Device: Protector; Device: Supreme

Study type: Interventional

Funder types: Other

Identifiers

NCT03214497

Schulthess_Anä_11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups, including a placebo group

Protector group

Active Comparator group

Description:

All patients collocated randomly to the Protector Group Primary and secondary outcome Parameters are studied

Treatment:

Device: Protector

Supreme group

Placebo Comparator group

Description:

All patients collocated randomly to the Supreme Group, Primary and secondary outcome Parameters are studied

Treatment:

Device: Supreme