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Completed

NCT Number: NCT02856672

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

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.

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Key information

Conditions

Adverse Anesthesia Outcome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supreme Laryngeal Mask Airway

Device

Supreme Laryngeal Mask Airway

Laryngeal Tube Suction Disposable

Device

Laryngeal Tube Suction Disposable

Primary outcomes

  1. Primary outcome oropharyngeal seal pressures, in cm H2O

    Time frame: 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 outcomes

  1. Fiberoptic position

    Time frame: 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).

Other outcomes

  1. Sore throat

    Time frame: 30 minutes after admission in Post Anesthetic Operative Unit ( PACU) and 24 hours postoperatively

    Sore throat was assessed subjetively by the patient using the 0-10 Numeric Pain Rating Scale

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Collaborators

  • Hospital Italiano de Buenos Aires

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Aug 5, 2016
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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