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

NCT ID: NCT02856672

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Adverse Anesthesia Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Supreme Laryngeal Mask Airway

Supreme Laryngeal Mask Airway

Group Type: ACTIVE_COMPARATOR

Supreme Laryngeal Mask Airway

Intervention Type: DEVICE

Supreme Laryngeal Mask Airway

Laryngeal Tube Suction Disposable

Intervention Type: DEVICE

Laryngeal Tube Suction Disposable

Laryngeal Tube Suction Disposable

Laryngeal Tube Suction Disposable

Group Type: ACTIVE_COMPARATOR

Supreme Laryngeal Mask Airway

Intervention Type: DEVICE

Supreme Laryngeal Mask Airway

Laryngeal Tube Suction Disposable

Intervention Type: DEVICE

Laryngeal Tube Suction Disposable

Interventions

Supreme Laryngeal Mask Airway

Supreme Laryngeal Mask Airway

Intervention Type: DEVICE

Laryngeal Tube Suction Disposable

Laryngeal Tube Suction Disposable

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role: collaborator

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

LUIS.GAITINI

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis A Gaitini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center and Hospital Italiano de Buenos Aires

References

Somri M, Vaida S, Garcia Fornari G, Mendoza GR, Charco-Mora P, Hawash N, Matter I, Swaid F, Gaitini L. A randomized prospective controlled trial comparing the laryngeal tube suction disposable and the supreme laryngeal mask airway: the influence of head and neck position on oropharyngeal seal pressure. BMC Anesthesiol. 2016 Oct 6;16(1):87. doi: 10.1186/s12871-016-0237-7.

Reference Type: DERIVED

PMID: 27716165 (View on PubMed)

Other Identifiers

BnaiZionMC-16-LG-001

Identifier Type: -

Identifier Source: org_study_id