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Protector™ Versus Supreme® Laryngeal Mask Airway

NCT ID: NCT03214497

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-12

Study Completion Date

2017-11-28

Brief Summary

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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

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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

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Anesthesia

Keywords

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laryngeal mask Supreme Protector

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Protector group

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

Group Type ACTIVE_COMPARATOR

Protector

Intervention Type DEVICE

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

Supreme group

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

Group Type PLACEBO_COMPARATOR

Supreme

Intervention Type DEVICE

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

Interventions

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Protector

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

Intervention Type DEVICE

Supreme

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Berthold Moser, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik

Locations

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Christian Keller

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Schulthess_Anä_11

Identifier Type: -

Identifier Source: org_study_id