Protector™ Versus Supreme® Laryngeal Mask Airway

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214497
• Other study ID #: Schulthess_Anä_11
• Status: Completed
• Phase: N/A
• First received: June 28, 2017
• Last updated: November 30, 2017
• Start date: July 12, 2017
• Est. completion date: November 28, 2017

Study information

• Verified date: November 2017
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Protector
All patients which are assigned to the Protector are studied with this laryngeal mask
• Supreme
All patients which are assigned to the Supreme are studied with this laryngeal mask

Locations

Country	Name	City	State
Switzerland	Christian Keller	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OLP	oropharyngeal leak pressure	5 minutes
Secondary	insertion	insertion of LMA	5 minutes
Secondary	time of insertion	time of Insertion of LMA	5 minutes
Secondary	Brimacombe score	Brimacombe score	5 minutes
Secondary	respiratory pressure	maximum respiratory pressure for adequate ventilation	5 minutes
Secondary	suctioning catheter	number needed of insertion of suctioning catheter	5 minutes
Secondary	suctioning fluids	ml suctioned from suctioning catheter	5 minutes
Secondary	CO2	endtidal CO2	5 minutes
Secondary	blood staining	visible blood staining after removal of the laryngeal mask	5 minutes
Secondary	airway morbidity	assess sore throat, neck pain	3 hours