Temperature Dependent Changes in I-gel Masks

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976726
• Other study ID #: 05/19
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 31, 2019
• Est. primary completion date: May 10, 2019
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Elective surgery

Exclusion Criteria:

• Contraindications for the use of i-gel masks.

• Emergency operation

• non fasted patient

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• Comparison of physcial parameters
Increasement of weight, volume expansion and decrease of density are measured.

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (8)

Chauhan G, Nayar P, Seth A, Gupta K, Panwar M, Agrawal N. Comparison of clinical performance of the I-gel with LMA proseal. J Anaesthesiol Clin Pharmacol. 2013 Jan;29(1):56-60. doi: 10.4103/0970-9185.105798. — View Citation

Dingley J, Stephenson J, Allender V, Dawson S, Williams D. Changes in hardness and resilience of i-gel(TM) cuffs with temperature: a benchtop study. Anaesthesia. 2018 Jul;73(7):856-862. doi: 10.1111/anae.14300. Epub 2018 May 3. — View Citation

Gabbott DA, Beringer R. The iGEL supraglottic airway: a potential role for resuscitation? Resuscitation. 2007 Apr;73(1):161-2. Epub 2007 Feb 7. — View Citation

Jadhav PA, Dalvi NP, Tendolkar BA. I-gel versus laryngeal mask airway-Proseal: Comparison of two supraglottic airway devices in short surgical procedures. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):221-5. doi: 10.4103/0970-9185.155153. — View Citation

Janakiraman C, Chethan DB, Wilkes AR, Stacey MR, Goodwin N. A randomised crossover trial comparing the i-gel supraglottic airway and classic laryngeal mask airway. Anaesthesia. 2009 Jun;64(6):674-8. doi: 10.1111/j.1365-2044.2009.05898.x. — View Citation

Komasawa N, Nishihara I, Tatsumi S, Minami T. Prewarming of the i-gel facilitates successful insertion and ventilation efficacy with muscle relaxation: a randomized study. J Clin Anesth. 2014 Dec;26(8):663-7. doi: 10.1016/j.jclinane.2014.08.009. Epub 2014 — View Citation

Russo SG, Cremer S, Eich C, Jipp M, Cohnen J, Strack M, Quintel M, Mohr A. Magnetic resonance imaging study of the in vivo position of the extraglottic airway devices i-gel™ and LMA-Supreme™ in anaesthetized human volunteers. Br J Anaesth. 2012 Dec;109(6) — View Citation

Theiler LG, Kleine-Brueggeney M, Kaiser D, Urwyler N, Luyet C, Vogt A, Greif R, Unibe MM. Crossover comparison of the laryngeal mask supreme and the i-gel in simulated difficult airway scenario in anesthetized patients. Anesthesiology. 2009 Jul;111(1):55- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Changes of masks weight.	Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.
Primary	Volume	Changes of masks volume.	Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.
Primary	Density	Changes of masks density.	Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.