Laryngeal MasksEVGNCT03619057
Voice Tessitura and Size of the Required Laryngeal Mask
An observational study of Laryngeal Masks, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Laryngeal Masks
- What is being tested?
- General anesthesia with laryngeal mask i-gel
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 24 Sep 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients up to 10 years old with planned surgery and anticipated use of laryngeal mask i-gel.
Who may be able to join
- Age ≥ 10 years
- Planned surgical procedure with the use of a laryngeal mask
Who cannot join
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.
The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).
Read more
I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.
Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.
The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.
This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.
- Conditions
- Laryngeal Masks
- Being tested
- General anesthesia with laryngeal mask i-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia with laryngeal mask i-gelOther
General anesthesia with laryngeal mask i-gel
| Study group | Role | What they receive |
|---|---|---|
| > 18 years | Not described Receives: Other: General anesthesia with laryngeal mask i-gel | |
| 10 to 18 years | Not described Receives: Other: General anesthesia with laryngeal mask i-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between the weight and the tessitura threshold
Concordance between the size of the mask proposed as a function of the weight and that determined after determination of the tessitura threshold for each mask size by ROC curves.
Measured: 1 day
Secondary outcomes (1)
Determining the tessitura threshold corresponding to each mask size
tessitura threshold (the most serious sound emitted by the patient) corresponding to each mask size
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Oct 2018
- Primary completion23 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal MasksStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619057
- Sponsor's protocol ID
- EVG
- Acronym
- EVG
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Tessitura and Size of the Required Laryngeal Mask
- ClinicalTrials.gov ID
- NCT03619057
- Acronym / sponsor ID
- EVG / EVG
- Conditions
- Laryngeal Masks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 7 Aug 2018 (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 choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.
The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).
I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.
Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.
The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.
This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| > 18 years | – | Other: General anesthesia with laryngeal mask i-gel |
| 10 to 18 years | – | Other: General anesthesia with laryngeal mask i-gel |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients up to 10 years old with planned surgery and anticipated use of laryngeal mask i-gel.
Key inclusion criteria (2 listed)
- Age ≥ 10 years
- Planned surgical procedure with the use of a laryngeal mask
Key exclusion criteria (1 listed)
- Refusal to participate in the study.
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 |
|---|---|---|
| General anesthesia with laryngeal mask i-gelGeneral anesthesia with laryngeal mask i-gel | Other | 10 to 18 years, > 18 years |
Primary outcome
Concordance between the weight and the tessitura threshold
Time frame: 1 day
Concordance between the size of the mask proposed as a function of the weight and that determined after determination of the tessitura threshold for each mask size by ROC curves.
1 secondary outcome
Determining the tessitura threshold corresponding to each mask size
Time frame: 1 day
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 9 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Laryngeal Masks, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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 2 inclusion and 1 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 9 Jul 2020. 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 France. 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?
Concordance between the weight and the tessitura threshold (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2020.