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Completed

NCT Number: NCT02566291

Observational Study With Investigation of Two Second Generation Laryngeal Masks

In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.

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Key information

Conditions

Airway Remodeling Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology;

Mainz, Rhineland-Palatinate, D55131, Germany

About this study

After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 Years
  • No concurrent participation in another study
  • capacity to consent
  • Present written informed consent of the research participant
  • Elective surgery under general anesthesia

Exclusion criteria

  • Age <18 years
  • Existing pregnancy
  • Lack of consent
  • inability to consent
  • emergency patients
  • Emergency situations in the context of a Difficult Airway Management
  • ASA classification> 3
  • situations where the possibility of accumulated gastric contents
  • Participation in another study

Treatment and study plan

Success

Device

Success rate and time for insertion

Primary outcomes

  1. Success rate

    Time frame: 70-98 Percent

    overall and first attempt success rate

Secondary outcomes

  1. Time for insertion

    Time frame: 5-120 seconds

  2. Leakage in ml.min

    Time frame: 0-300 ml.min

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study

Acronym: OSSGA

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2015
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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