Temperature Dependent Changes in I-gel Masks

June 4, 2019 updated by: Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital

Influence of Temperature on Volume, Weight and Density Changes of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Masks used in patients (n=5 per size; #3, #4, #5) requiring general anaesthesia for elective surgery without contraindications for i-gel® were collected postoperatively.

Description

Inclusion Criteria:

  • Elective surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
i-gel size #3
Results of benchtop investigations are compared to in patient-used masks. Increasement of weight, volume expansion and decrease of density are measured.
Device: Comparison of physcial parameters
Increasement of weight, volume expansion and decrease of density are measured.
i-gel size #4
Results of benchtop investigations are compared to in patient-used masks. Increasement of weight, volume expansion and decrease of density are measured.
Device: Comparison of physcial parameters
Increasement of weight, volume expansion and decrease of density are measured.
i-gel size #5
Results of benchtop investigations are compared to in patient-used masks. Increasement of weight, volume expansion and decrease of density are measured.
Device: Comparison of physcial parameters
Increasement of weight, volume expansion and decrease of density are measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.
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.
Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.
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.
Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Florian J Raimann, Dr., University Hospital Frankfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

May 10, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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