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

Bnai Zion Medical Center

Status: Completed

Conditions: Adverse Anesthesia Outcome

Treatments: Device: Laryngeal Tube Suction Disposable; Device: Supreme Laryngeal Mask Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT02856672

BnaiZionMC-16-LG-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Supreme Laryngeal Mask Airway

Active Comparator group

Description:

Supreme Laryngeal Mask Airway

Treatment:

Device: Laryngeal Tube Suction Disposable

Device: Supreme Laryngeal Mask Airway

Laryngeal Tube Suction Disposable

Active Comparator group

Description:

Laryngeal Tube Suction Disposable

Treatment:

Device: Laryngeal Tube Suction Disposable

Device: Supreme Laryngeal Mask Airway