Airway ManagementNCT03976726
Temperature Dependent Changes in I-gel Masks
An observational study of Airway Management, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Management
- What is being tested?
- Comparison of physcial parameters
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Elective surgery
Who cannot join
- Contraindications for the use of i-gel masks.
- Emergency operation
- non fasted patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Airway Management
- Being tested
- Comparison of physcial parameters
- Keywords
- Laryngel Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of physcial parametersDevice
Increasement of weight, volume expansion and decrease of density are measured.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Comparison of physcial parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Changes of masks weight.
Measured: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.
Volume
Changes of masks volume.
Measured: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.
Density
Changes of masks density.
Measured: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Apr 2019
- Primary completion10 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital
- Investigators
- Florian J Raimann, Dr., Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976726
- Sponsor's protocol ID
- 05/19
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23493414Gabbott 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.
PubMed 17289250Jadhav 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.
PubMed 25948905Janakiraman 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.
PubMed 19453322Russo 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.
PubMed 23015619Theiler 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.
PubMed 19512881Dingley 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.
PubMed 29722434Komasawa 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.
PubMed 25468575
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Temperature on Volume, Weight and Density Changes of I-gel® Masks
- ClinicalTrials.gov ID
- NCT03976726
- Acronym / sponsor ID
- 05/19
- Conditions
- Airway Management
- Keywords
- Laryngel Mask
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| i-gel size #3 | – | Device: Comparison of physcial parametersResults of benchtop investigations are compared to in patient-used masks. Increasement of weight, volume expansion and decrease of density are measured. |
| i-gel size #4 | – | Device: Comparison of physcial parametersResults of benchtop investigations are compared to in patient-used masks. Increasement of weight, volume expansion and decrease of density are measured. |
| i-gel size #5 | – | Device: Comparison of physcial parametersResults of benchtop investigations are compared to in patient-used masks. Increasement of weight, volume expansion and decrease of density are measured. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Elective surgery
Key exclusion criteria (3 listed)
- Contraindications for the use of i-gel masks.
- Emergency operation
- non fasted patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of physcial parametersIncreasement of weight, volume expansion and decrease of density are measured. | Device | i-gel size #3, i-gel size #4, i-gel size #5 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Results publication: PubMed 23493414Chauhan 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.
- Results publication: PubMed 17289250Gabbott 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.
- Results publication: PubMed 25948905Jadhav 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.
- Results publication: PubMed 19453322Janakiraman 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.
- Results publication: PubMed 23015619Russo 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.
- Results publication: PubMed 19512881Theiler 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.
- Results publication: PubMed 29722434Dingley 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.
- Results publication: PubMed 25468575Komasawa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian J Raimann, Dr. principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Two consecutive measurements within 15 minutes once the mask temperature has cooled from body temperature to room temperature.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976726, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.