Protector™ Versus Supreme® Laryngeal Mask Airway | NCT03214497

Studies
Protector™ Versus Supreme® Laryngeal Mask Airway

NCT03214497

Sponsor

Schulthess Klinik

Status

Completed

Last Update Posted

Dec 2, 2017Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Protector
Supreme

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2017Actual

Primary Completion Date

Nov 28, 2017Actual

Completion Date

Nov 28, 2017Actual

First Submitted Date

Jun 28, 2017

First Submission Date that Met QC Criteria

Jul 10, 2017

First Posted Date

Jul 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2017

Last Update Posted Date

Dec 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Protector	Device	All patients which are assigned to the Protector are studied with this laryngeal mask	Protector group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OLP	oropharyngeal leak pressure	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
insertion	insertion of LMA	5 minutes
time of insertion	time of Insertion of LMA	5 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Berthold Moser, MD, MBA	Schulthess Klinik	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christian Keller		Zurich		8008	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009064	Mouth Protectors

Ancestor Terms

ID	Term
D011313	Preventive Dentistry
D003813	Dentistry
D011482	Protective Devices
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided