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Completed

NCT Number: NCT03214497

Protector™ Versus 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.

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Key information

Conditions

Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christian Keller

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protector

Device

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

Supreme

Device

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

Primary outcomes

  1. OLP

    Time frame: 5 minutes

    oropharyngeal leak pressure

Secondary outcomes

  1. insertion

    Time frame: 5 minutes

    insertion of LMA

  2. time of insertion

    Time frame: 5 minutes

    time of Insertion of LMA

  3. Brimacombe score

    Time frame: 5 minutes

    Brimacombe score

  4. respiratory pressure

    Time frame: 5 minutes

    maximum respiratory pressure for adequate ventilation

  5. suctioning catheter

    Time frame: 5 minutes

    number needed of insertion of suctioning catheter

  6. suctioning fluids

    Time frame: 5 minutes

    ml suctioned from suctioning catheter

  7. CO2

    Time frame: 5 minutes

    endtidal CO2

  8. blood staining

    Time frame: 5 minutes

    visible blood staining after removal of the laryngeal mask

  9. airway morbidity

    Time frame: 3 hours

    assess sore throat, neck pain

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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