NCT02859922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

July 25, 2016

Last Update Submit

August 16, 2016

Conditions

Adverse Anesthesia Outcome

Keywords

Laryngeal Tube Supreme Spontaneous Ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time to achieve an effective airway in sec

    15 sec

Other Outcomes (1)

  • Sore throat in Numeric Rating Scale.

    After the patient was released from Post Anesthesic Care Unit and 24 hours postoperatively.

Study Arms (2)

Supreme Laryngeal Mask Airway

ACTIVE COMPARATOR

Supreme Laryngeal Mask Airway

Device: Supreme Laryngeal Mask Airway

Laryngeal Tube Suction Disposable

ACTIVE COMPARATOR

Laryngeal Tube Suction Disposable

Device: Laryngeal Tube Suction Disposable

Interventions

Laryngeal Tube Suction DisposableDEVICE

Laryngeal Tube Suction Disposable

Laryngeal Tube Suction Disposable
Supreme Laryngeal Mask AirwayDEVICE

Supreme Laryngeal Mask Airway

Supreme Laryngeal Mask Airway

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luis A Gaitini M.D.

Haifa, Israel

Location

Study Officials

  • Luis A Gaitini, M.D.

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 9, 2016

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

November 1, 2012

Last Updated

August 17, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

IL(1)