Protector™ Versus Supreme® Laryngeal Mask Airway

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: Supreme; Device: Protector

• Registration Number: NCT03214497
• Lead Sponsor: Schulthess Klinik

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.

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Study Start: 2017-07-12
• Status Verified: 2017-11
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
OLP	5 minutes	oropharyngeal leak pressure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Christian Keller; 🇨🇭 Zürich, Switzerland