NCT03214497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

June 28, 2017

Last Update Submit

November 30, 2017

Conditions

Anesthesia

Keywords

laryngeal maskSupremeProtector

Outcome Measures

Primary Outcomes (1)

  • OLP

    oropharyngeal leak pressure

    5 minutes

Secondary Outcomes (9)

  • insertion

    5 minutes

  • time of insertion

    5 minutes

  • Brimacombe score

    5 minutes

  • respiratory pressure

    5 minutes

  • suctioning catheter

    5 minutes

  • +4 more secondary outcomes

Study Arms (2)

Protector group

ACTIVE COMPARATOR

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

Device: Protector

Supreme group

PLACEBO COMPARATOR

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

Device: Supreme

Interventions

ProtectorDEVICE

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

Protector group
SupremeDEVICE

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

Supreme group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-75
  • ASA 1-3
  • Operation on limbs
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Keller

Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Mouth Protectors

Intervention Hierarchy (Ancestors)

Preventive DentistryDentistryProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Berthold Moser, MD, MBA

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 11, 2017

Study Start

July 12, 2017

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Locations

CH(1)