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Clinical Trials/NCT03214497
NCT03214497
Completed
Not Applicable

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

Schulthess Klinik1 site in 1 country96 target enrollmentJuly 12, 2017
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ConditionsAnesthesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Schulthess Klinik
Enrollment
96
Locations
1
Primary Endpoint
OLP
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2017
End Date
November 28, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Age between 18-75
  • •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
  • •acute disease where anaesthesia is in doubt
  • •no written consent

Outcomes

Primary Outcomes

OLP

Time Frame: 5 minutes

oropharyngeal leak pressure

Secondary Outcomes

  • insertion(5 minutes)
  • suctioning fluids(5 minutes)
  • blood staining(5 minutes)
  • Brimacombe score(5 minutes)
  • respiratory pressure(5 minutes)
  • suctioning catheter(5 minutes)
  • CO2(5 minutes)
  • airway morbidity(3 hours)
  • time of insertion(5 minutes)

Study Sites (1)

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