Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation

A Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation: A Randomized Prospective Study

The study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the LTS-D and the SLMA perform similarly during spontaneous ventilation 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

The Supreme Laryngeal Mask Airway (SLMA), (Intavent Orthofix, Maidenhead, UK), and Laryngeal Tube Suction -Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), are second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.

The SLMA has been compared to the Proseal Laryngeal Mask Airway (PLMA) during mechanical and spontaneous ventilation the LTS II (multiple use version of the LTS-D) with the PLMA.

Recently, the LTS-D and SLMA have been compared when used during pressure controlled mechanical ventilation.

To date, there is no published data comparing the SLMA to the LTS-D during spontaneous ventilation. The investigators hypothesized that the SLMA and LTS-D perform similarly during spontaneous ventilation despite differences in their structural design.

The chief aim of this prospective randomized study was to compare the SLMA and the LTS-D with respect to 1) Oxygen saturation and End Tidal carbone dioxide during spontaneous ventilation, 2) time to achieve an effective airway, 3) ease of insertion, 4) need for interventions to achieve an effective airway, 5) cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O, 6) ventilatory variables during spontaneous ventilation, 7) fiberoptic score, 8) adverse perioperative events.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Luis A Gaitini M.D.

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, American Society of Anesthesiologists ( ASA) physical status I and II, with normal airways for minor elective surgery.

Exclusion Criteria:

• Age <18 years,
• Weight <50 kg,
• Cervical spine disease limiting neck a known difficult airway, and
• Patients with active gastroesophageal reflux.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• 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
ACTIVE_COMPARATOR: Laryngeal Tube Suction Disposable	Device: Laryngeal Tube Suction Disposable; Laryngeal Tube Suction Disposable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation in percent	The data were recorded by the Anesthesia Delivery Unit (Datex-Ohmeda, Helsinki, Finland). monitor from starting the establishment of spontaneous ventilation until the device was removed	30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve an effective airway in sec	The time was measured in seconds after the anesthesiologist removed the facemask and insert the device and the square-wave capnograph tracing was observed.Two attempts at insertion were permitted. If unsuccessful the patient's airway was managed with a conventional endotracheal tube.	15 sec

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sore throat in Numeric Rating Scale.	Sore throat was assessed subjectively by the patient using the 0-10 Numeric Rating Scale.	After the patient was released from Post Anesthesic Care Unit and 24 hours postoperatively.

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (ESTIMATE): August 9, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Laryngeal Tube Supreme Spontaneous Ventilation
• Other Study ID Numbers: BnaiZionMC-16-LG-002

Plan for Individual participant data (IPD)

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