Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway
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
1 other identifier
interventional
160
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 25, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedAugust 5, 2016
August 1, 2016
1 year
July 25, 2016
August 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome oropharyngeal seal pressures, in cm H2O
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)
5 min
Secondary Outcomes (1)
Fiberoptic position
5 min
Other Outcomes (1)
Sore throat
30 minutes after admission in Post Anesthetic Operative Unit ( PACU) and 24 hours postoperatively
Study Arms (2)
Supreme Laryngeal Mask Airway
ACTIVE COMPARATORSupreme Laryngeal Mask Airway
Laryngeal Tube Suction Disposable
ACTIVE COMPARATORLaryngeal Tube Suction Disposable
Interventions
Supreme Laryngeal Mask Airway
Laryngeal Tube Suction Disposable
Eligibility Criteria
You may qualify if:
- Patients ASA I and II with normal airways, for minor elective surgical
You may not qualify if:
- Age \<18 yr, weight \<50 kg, or \> 100 kg , a known difficult airway, active gastro esophageal reflux disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bnai Zion Medical Centerlead
- Hospital Italiano de Buenos Airescollaborator
Related Publications (1)
Somri M, Vaida S, Garcia Fornari G, Mendoza GR, Charco-Mora P, Hawash N, Matter I, Swaid F, Gaitini L. 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. BMC Anesthesiol. 2016 Oct 6;16(1):87. doi: 10.1186/s12871-016-0237-7.
PMID: 27716165DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Luis A Gaitini, M.D.
Bnai Zion Medical Center and Hospital Italiano de Buenos Aires
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
July 25, 2016
First Posted
August 5, 2016
Study Start
January 1, 2009
Primary Completion
January 1, 2010
Study Completion
October 1, 2012
Last Updated
August 5, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share