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

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

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.

Study Overview

• Status: Completed
• Conditions: Adverse Anesthesia Outcome
• Intervention / Treatment: Device: Supreme Laryngeal Mask Airway; Device: Laryngeal Tube Suction Disposable

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supreme Laryngeal Mask Airway	Device: Supreme Laryngeal Mask Airway; Supreme Laryngeal Mask Airway; Device: Laryngeal Tube Suction Disposable; Laryngeal Tube Suction Disposable
Active Comparator: Laryngeal Tube Suction Disposable	Device: Supreme Laryngeal Mask Airway; Supreme Laryngeal Mask Airway; Device: Laryngeal Tube Suction Disposable; Laryngeal Tube Suction Disposable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome oropharyngeal seal pressures, in cm H2O	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)	5 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fiberoptic position	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).	5 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sore throat	Sore throat was assessed subjetively by the patient using the 0-10 Numeric Pain Rating Scale	30 minutes after admission in Post Anesthetic Operative Unit ( PACU) and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Collaborators: Hospital Italiano de Buenos Aires
• Investigators: Principal Investigator: Luis A Gaitini, M.D., Bnai Zion Medical Center and Hospital Italiano de Buenos Aires

Publications and helpful links

General Publications

• 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. Erratum In: BMC Anesthesiol. 2016 Dec 13;16(1):123.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 4, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Laryngeal Tube Supreme Laryngeal Mask Airway Leak Pressure
• Other Study ID Numbers: BnaiZionMC-16-LG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES