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Evaluation of Supraglottic Airway Devices in Children and Comparison to Historic Control

NCT01625858 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2014-09-03

No results posted yet for this study

Summary

The supraglottic airway device LMA Supreme has recently been introduced for pediatric patients. The investigators will prospectively evaluate success rate and airway leak pressure in everyday's clinical pediatric anesthesia practice. Primary hypothesis is that the LMA Supreme has a leak pressure with a 95% confidence interval of 18-22cmH2O. Leak pressures will be compared to results from other pediatric supraglottic airway devices previously studied by the investigators group. Secondary Hypothesis: The primary success rate of the LMA-S is higher than 90%; therefore, performance is similar to the performance of the Ambu Aura Once™ and of the i-gel™. Study design: Prospective controlled observational cohort study.

In a second step, we will include more pediatric supraglottic airway devices. Each new arm will be handled exactly the same, assuming the same hypothesis being justified.

Conditions

  • Evaluation of Success Rate
  • Airway Leak Pressure
  • Side Effects of LMA Supreme in Pediatric Patients Undergoing General Anesthesia

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Robert Greif, MD MME · University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01625858 on ClinicalTrials.gov