Protector™ Versus Supreme® Laryngeal Mask Airway

November 30, 2017 updated by: Schulthess Klinik

Prospective Randomised Trial of the Protector™ Versus the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8008
        • Christian Keller

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Protector group
All patients collocated randomly to the Protector Group Primary and secondary outcome Parameters are studied
Device: Protector
All patients which are assigned to the Protector are studied with this laryngeal mask
Placebo Comparator: Supreme group
All patients collocated randomly to the Supreme Group, Primary and secondary outcome Parameters are studied
Device: Supreme
All patients which are assigned to the Supreme are studied with this laryngeal mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OLP
Time Frame: 5 minutes
oropharyngeal leak pressure
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion
Time Frame: 5 minutes
insertion of LMA
5 minutes
time of insertion
Time Frame: 5 minutes
time of Insertion of LMA
5 minutes
Brimacombe score
Time Frame: 5 minutes
Brimacombe score
5 minutes
respiratory pressure
Time Frame: 5 minutes
maximum respiratory pressure for adequate ventilation
5 minutes
suctioning catheter
Time Frame: 5 minutes
number needed of insertion of suctioning catheter
5 minutes
suctioning fluids
Time Frame: 5 minutes
ml suctioned from suctioning catheter
5 minutes
CO2
Time Frame: 5 minutes
endtidal CO2
5 minutes
blood staining
Time Frame: 5 minutes
visible blood staining after removal of the laryngeal mask
5 minutes
airway morbidity
Time Frame: 3 hours
assess sore throat, neck pain
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Investigators

  • Principal Investigator: Berthold Moser, MD, MBA, Schulthess Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2017

Primary Completion (Actual)

November 28, 2017

Study Completion (Actual)

November 28, 2017

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Schulthess_Anä_11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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