Clinical trial NCT02859922: Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation
Official title: A Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Anesthesia Outcome
Keywords: Laryngeal Tube Supreme Spontaneous Ventilation
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxygen saturation in percent
timeFrame: 30 min
Secondary outcomes:
measure: Time to achieve an effective airway in sec
timeFrame: 15 sec
Other outcomes:
measure: Sore throat in Numeric Rating Scale.
timeFrame: After the patient was released from Post Anesthesic Care Unit and 24 hours postoperatively.
Locations:
city: Haifa
country: Israel
facility: Luis A Gaitini M.D.
Study officials:
affiliation: Bnai Zion Medical Center
name: Luis A Gaitini, M.D.
role: PRINCIPAL_INVESTIGATOR
References: