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Clinical Trials/NCT02856672
NCT02856672
Completed
Not Applicable

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

Bnai Zion Medical Center0 sites160 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adverse Anesthesia Outcome
Sponsor
Bnai Zion Medical Center
Enrollment
160
Primary Endpoint
Primary outcome oropharyngeal seal pressures, in cm H2O
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
October 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LUIS.GAITINI

M.D.

Bnai Zion Medical Center

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

Outcomes

Primary Outcomes

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

  • Fiberoptic position(5 min)

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