Skip to main content
OpenTrials
Completed

NCT Number: NCT03976726

Temperature Dependent Changes in I-gel Masks

The i-gel® mask is a second generation, single use supraglottic airway device which does not have an inflatable cuff. The cuff consists of a thermoplastic elastomer and its mechanism of sealing still remains unclear. Various theories such as temperature-dependent changes in hardness and volume expansion as well as fluid absorption have been discussed.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

The i-gel® mask (Intersurgical, Workingham, UK), is a second generation, single use supraglottic airway device. In contrast to other devices its' cuff consists of a thermoplastic elastomer (styrene-ethylene-butadine-styrene) instead of an inflatable cuff.

Previous studies have shown, that over time the sealing improved compared to the moment of insertion. The sealing process may be based on various mechanisms. It is assumed, that the warming from room to body temperature leads to an improved adaptation to the patient-specific anatomy due to a softening of the elastomer. By definition, an elastomer is softened by the effect of temperature and become harder when reaching the glass transition temperature.

In this context, Dingley et al. described a change in the degree of hardness as a function of temperature. Prewarmed i-gel® masks (42°C, 30min.) seem to have smaller leak volumes compared to masks stored at room temperature postinsertion in paralyzed patients, but was not reproducible in non-paralyzed patients. Looking at the sealing pressure Chauhan et al. reported that i-gel® masks required a lower pressure compared to masks with an inflatable cuff.

At this point it is not yet clear, whether the thermoplastic cuff material only expands due to an increase in temperature. Liquid absorption and a consecutive expansion is also theoretically conceivable.

Therefore, the aim of the present study is to examine the i-gel® mask within the scope of a benchtop study for temperature-dependent volume expansion and liquid absorption.

Who can participate

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

Inclusion criteria

  • Elective surgery

Exclusion criteria

  • Contraindications for the use of i-gel masks.
  • Emergency operation
  • non fasted patient

Treatment and study plan

Comparison of physcial parameters

Device

Increasement of weight, volume expansion and decrease of density are measured.

Primary outcomes

  1. Weight

    Time frame: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.

    Changes of masks weight.

  2. Volume

    Time frame: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.

    Changes of masks volume.

  3. Density

    Time frame: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.

    Changes of masks density.

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Influence of Temperature on Volume, Weight and Density Changes of I-gel® Masks

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
Jun 6, 2019

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.

Published trials that share one or more normalized conditions with this study.