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出境医 / 临床实验 / Temperature Dependent Changes in I-gel Masks

Temperature Dependent Changes in I-gel Masks

Study Description
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.

Condition or disease Intervention/treatment
Airway Management Device: Comparison of physcial parameters

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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Influence of Temperature on Volume, Weight and Density Changes of I-gel® Masks
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 31, 2019
Arms 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.
Outcome Measures
Primary Outcome Measures :
  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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.
Criteria

Inclusion Criteria:

  • Elective surgery

Exclusion Criteria:

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

Locations
Layout table for location information
Germany
University Hospital Frankfurt
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Florian J Raimann, Dr. University Hospital, Frankfurt
Tracking Information
First Submitted Date June 2, 2019
First Posted Date June 6, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date April 1, 2019
Actual Primary Completion Date May 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Temperature Dependent Changes in I-gel Masks
Official Title Influence of Temperature on Volume, Weight and Density Changes of I-gel® Masks
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Airway Management
Intervention Device: Comparison of physcial parameters
Increasement of weight, volume expansion and decrease of density are measured.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Device: Comparison of physcial parameters
Publications *
  • 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.
  • Gabbott DA, Beringer R. The iGEL supraglottic airway: a potential role for resuscitation? Resuscitation. 2007 Apr;73(1):161-2. Epub 2007 Feb 7.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 4, 2019) 		15
Original Actual Enrollment Same as current
Actual Study Completion Date May 31, 2019
Actual Primary Completion Date May 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Elective surgery

Exclusion Criteria:

  • Contraindications for the use of i-gel masks.
  • Emergency operation
  • non fasted patient
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03976726
Other Study ID Numbers 05/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital
Study Sponsor Johann Wolfgang Goethe University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Florian J Raimann, Dr. University Hospital, Frankfurt
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date June 2019

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