Temperature Dependent Changes in I-gel Masks

NCT03976726 | Completed

• 1 other identifier: 05/19
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Management

Keywords

Laryngel Mask

Outcome Measures

Primary Outcomes (3)

• Weight

  Changes of masks weight.

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

• Volume

  Changes of masks volume.

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

• Density

  Changes of masks density.

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

Study Arms (3)

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

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

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

Interventions

Comparison of physcial parameters DEVICE

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

i-gel size #3; i-gel size #4; i-gel size #5

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Elective surgery

You may not qualify if:

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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Related 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.

  PMID: 23493414 RESULT

• Gabbott DA, Beringer R. The iGEL supraglottic airway: a potential role for resuscitation? Resuscitation. 2007 Apr;73(1):161-2. doi: 10.1016/j.resuscitation.2006.10.026. Epub 2007 Feb 7. No abstract available.

  PMID: 17289250 RESULT

• 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.

  PMID: 25948905 RESULT

• 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.

  PMID: 19453322 RESULT

• 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):996-1004. doi: 10.1093/bja/aes314. Epub 2012 Sep 25.

  PMID: 23015619 RESULT

• 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):55-62. doi: 10.1097/ALN.0b013e3181a4c6b9.

  PMID: 19512881 RESULT

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

  PMID: 29722434 RESULT

• 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 Nov 18.

  PMID: 25468575 RESULT

Study Officials

• Florian J Raimann, Dr.

  Goethe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 6, 2019
• Study Start: April 1, 2019
• Primary Completion: May 10, 2019
• Study Completion: May 31, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)