Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02856672
Enrollment
160
Registered
2016-08-05
Start date
2009-01-31
Completion date
2012-10-31
Last updated
2016-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Anesthesia Outcome

Keywords

Laryngeal Tube Supreme Laryngeal Mask Airway Leak Pressure

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.

Interventions

Laryngeal Tube Suction Disposable

Supreme Laryngeal Mask Airway

Sponsors

Hospital Italiano de Buenos Aires
CollaboratorOTHER
Bnai Zion Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary outcome oropharyngeal seal pressures, in cm H2O5 minOropharyngeal 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

MeasureTime frameDescription
Fiberoptic position5 minScoring 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

MeasureTime frameDescription
Sore throat30 minutes after admission in Post Anesthetic Operative Unit ( PACU) and 24 hours postoperativelySore throat was assessed subjetively by the patient using the 0-10 Numeric Pain Rating Scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026