Clinical trial NCT02856672: Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Anesthesia Outcome
Keywords: Laryngeal Tube Supreme Laryngeal Mask Airway Leak Pressure
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Italiano de Buenos Aires
First posted: 2016-08-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Primary outcome oropharyngeal seal pressures, in cm H2O
timeFrame: 5 min
Secondary outcomes:
measure: Fiberoptic position
timeFrame: 5 min
Other outcomes:
measure: Sore throat
timeFrame: 30 minutes after admission in Post Anesthetic Operative Unit ( PACU) and 24 hours postoperatively
Locations:
Study officials:
affiliation: Bnai Zion Medical Center and Hospital Italiano de Buenos Aires
name: Luis A Gaitini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.