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

Adverse Anesthesia Outcome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856672
• Other study ID #: BnaiZionMC-16-LG-001
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: August 4, 2016
• Start date: January 2009
• Est. completion date: October 2012

Study information

• Verified date: August 2016
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

Device:
• Supreme Laryngeal Mask Airway
Supreme Laryngeal Mask Airway
• Laryngeal Tube Suction Disposable
Laryngeal Tube Suction Disposable

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bnai Zion Medical Center	Hospital Italiano de Buenos Aires

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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