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

Adverse Anesthesia Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859922
• Other study ID #: BnaiZionMC-16-LG-002
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: August 16, 2016
• Start date: January 2009
• Est. completion date: November 2012

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

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

Locations

Country	Name	City	State
Israel	Luis A Gaitini M.D.	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Yes
Primary	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	Yes
Secondary	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	Yes