Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway

Not Applicable

Completed

• Conditions: Adverse Anesthesia Outcome
• Interventions: Device: Supreme Laryngeal Mask Airway; Device: Laryngeal Tube Suction Disposable

• Registration Number: NCT02856672
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate oropharyngeal seal pressure in different head and neck positions and perform similarly during pressure controlled ventilation in neutral position, despite differences in their structural design.

Detailed Description

Laryngeal Tube Suction Disposable, LTS-D (VBM Medizintechnik GmbH , Sulz, Germany) and Supreme Laryngeal Mask Airway, SLMA (Intavent Orthofix, Maidenhead, UK) are second generation, single-use, supraglottic airway devices( SADs), with added gastric access, for use in spontaneously and mechanically ventilated patients undergoing general anesthesia.

The effectiveness of the LTS-D and the SLMA has been well established; however, the oropharyngeal seal pressure of both devices in different head/neck positions and the performance of these devices using positive pressure ventilation have not been evaluated. Changing the head/neck position can alter the sealing capabilities of the SAD.

To the investigators best knowledge there are no studies comparing the oropharyngeal seal pressure in different head and neck position when using these devices.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-01
• Study Completion: 2012-10
• Study First Submitted: 2016-07-25
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-04
• Last Update Submitted: 2016-08-04
• Study First Posted: 2016-08-05
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients ASA I and II with normal airways, for minor elective surgical

Exclusion Criteria

• Age <18 yr, weight <50 kg, or > 100 kg , a known difficult airway, active gastro esophageal reflux disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supreme Laryngeal Mask Airway	Supreme Laryngeal Mask Airway	Supreme Laryngeal Mask Airway
Laryngeal Tube Suction Disposable	Supreme Laryngeal Mask Airway	Laryngeal Tube Suction Disposable
Supreme Laryngeal Mask Airway	Laryngeal Tube Suction Disposable	Supreme Laryngeal Mask Airway
Laryngeal Tube Suction Disposable	Laryngeal Tube Suction Disposable	Laryngeal Tube Suction Disposable

Primary Outcome Measures

Name	Time	Method
Primary outcome oropharyngeal seal pressures, in cm H2O	5 min	Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of the 3 liters minute. The airway pressure at which an equilibrium was reached was noted( maximun allowed 40 cm H2O)

Secondary Outcome Measures

Name	Time	Method
Fiberoptic position	5 min	Scoring system of the fiberoptic view: ranged from grade 4 (full view of arytenoids and glottis), 3 (arytenoids and glottis partly visible), 2 (view of arytenoids, glottis or epiglottis), and 1 (no part of larynx identifiable).