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ObeseNCT03110393

Ambu®AuraGain™ Versus I-gel® in Obese Patients

A study testing Ambu AuraGain and Intersurgical i-gel in people with Obese, run by Schulthess Klinik at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical i-gel® and Ambu®AuraGain™) in obese patients Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Obese
What is being tested?
Ambu AuraGain and Intersurgical i-gel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSwitzerland
Study dates
20 Apr 2017to 6 Sep 2017
Phase
Interventional
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ASA 1-3
  • Shoulder-/Elbow-/Hip-/Knee- or Foot - Surgery
  • Signed informed consent
  • BMI > 35kg/m2

Who cannot join

  • Non-sober patients (last meal <6 h)
  • Symptomatic reflux disease
  • Hiatus hernia
  • Significant cardiovascular risk factors
  • Severe COPD
  • Gastric band or gastric bypass
Show all 11Show fewer
  • Disease which allows an accurate examination of the physicians (e.g. neuromuscular, mental, metabolic disease)
  • Drug or drug abuse in the recent past
  • Legal immaturity (incompetence)
  • Acute disease, which calls into question the narcotic potential
  • Patients with whom the use of a laryngeal mask is contraindicated or otherwise not possible

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Schulthess Klinik

    Zurich, 8008

Other trials in Switzerland

About this study

Official title: Prospective Randomized Comparison Between a Fiber Optic Intubation Via the Ambu® AuraGain ™ or the i-Gel® Laryngeal Mask Until a Complete Airway Protection in Obese Patients

The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical i-gel® and Ambu®AuraGain™) in obese patients

Read the detailed description

Since the incidence of a difficult intubation lies between 4.5% -7.5%, the search for alternative airway devices has been forced in the past.

As an option, the laryngeal mask is suitable, which has been used as a universal airway with a high degree of safety in routine anesthesia.

There are numbers of different laryngeal masks available which have the characteristic to insert an endotracheal tube through the ventilation lumen.

The indications for these laryngeal masks can be extended due to continuous improvements in the laryngeal masks, these laryngeal masks can also be used in obese patients. Obese patients generally have a 4-fold increased risk of a difficult airway, and a BMI over 35 is a predictor of a difficult tracheal intubation.

There are no studies comparing the Intersurgical i-gel® Laryngeal Mask and the Ambu®AuraGain ™ Laryngeal Mask in obese patients.

Conditions
Obese
Being tested
Ambu AuraGain, Intersurgical i-gel
Keywords
Obese, Laryngeal Mask Airway, Anaesthesia
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambu AuraGainDevice

    Insert and intubation of an Ambu® AuraGain™ laryngeal mask

  • Intersurgical i-gelDevice

    Insert and intubation of an Intersurgical i-gel®

Study groups in NCT03110393
Study groupRoleWhat they receive
Ambu® AuraGain™ExperimentalIntervention with Ambu® AuraGain™Laryngeal Mask
Receives: Device: Ambu AuraGain
Intersurgical i-gel®Active comparatorIntervention with Intersurgical i-gel® Laryngeal Mask
Receives: Device: Intersurgical i-gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of successful intubation

    Measurement of a fiberoptic intubation with the laryngeal mask. Start: Insertion of the fiberoptic into the larynxmask until the intubation has been done and after the fiberoptic has been removed.

    Measured: intraoperative

Secondary outcomes (22)

  1. Number of Insertions (of the laryngeal mask)

    Number of insertion attempts will be registered

    Measured: intraoperative

  2. Time of insertion

    The time of Insertion of the laryngeal mask will be recorded.

    Measured: intraoperative

  3. Number of insertion attempts

    Number of insertions with the stomach tube will be registered

    Measured: intraoperative

  4. Gastric volume

    Measurement of the gastric volume

    Measured: intraoperative

  5. Positioning of the gastric probe

    Determination of the position of the gastric probe after successful insertion by stethoscope.

    Measured: intraoperative

  6. Successful Ventilation

    Detection of a successful Ventilation. There are two options: a tidal volume > 6mL/kg lean body mass or endtidal pCO2 < 6.7kPa

    Measured: intraoperative

  7. Oropharyngeal leak pressure of the Ambu®AuraGain ™

    The oropharyngeal leak pressure of the AuraGain™ is measured with a measured cuff volume of 60cmH2O

    Measured: intraoperative

  8. Oropharyngeal leak pressure of the Intersurgical i-gel®

    The oropharyngeal leak pressure of the Intersurgical i-gel® is measured.

    Measured: intraoperative

  9. Measurement of blood pressure

    Measurement of blood pressure during 5min (1 measurement / minute).

    Measured: intraoperative

  10. Measurement of oxygen saturation

    Measurement oxygen saturation during 5min (1 measurement / minute).

    Measured: intraoperative

  11. Measurement of heart rate

    Measurement of heart rate during 5min (1 measurement / minute).

    Measured: intraoperative

  12. Maximum ventilation pressure

    The maximum ventilation pressure is measured, which must be applied in order to adequately ventilate the patients. This is measured over 5 minutes

    Measured: intraoperative

  13. Measurement CO2 (kPa):

    The exhaled CO2 is determined continuously.

    Measured: intraoperative

  14. Number of intubation attempts

    The number of intubation attempts until successful intubation is recorded.

    Measured: intraoperative

  15. Reasons for the unsuccessful intubation

    The reasons are listed in tabular form.

    Measured: intraoperative

  16. Number of esophageal intubations

    The number of esophageal intubations is measured.

    Measured: intraoperative

  17. Resistance (for an EET):

    The resistance is measured with a score of 1- 4. 1: simple passage, no resistance, 2: little resistance for the passage, 3: significant resistance for the passage, 4: passage not possible

    Measured: intraoperative

  18. Location of the mask (Brimacombe)

    The position of the mask is determined by pushing the fiber optic to a maximum of 1cm over the LMA and then using the Brimacombe score.

    Measured: intraoperative

  19. Swallowing (no / little / medium / strong)

    The swallowing difficulties are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).

    Measured: 5hour postoperative

  20. Throat pain (no / little / medium / strong)

    The throat pain is questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).

    Measured: 5hour postoperative

  21. Hoarseness (no / little / medium / strong)

    The swallowing difficulties, the throat pain and the hoarseness are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).

    Measured: 5hour postoperative

  22. Blood on laryngeal mask after intubation

    Determination of the visible blood on the laryngeal mask after removal (no, little, much).

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start20 Apr 2017
  3. Primary completion6 Sep 2017
  4. Study completion6 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03110393
Sponsor's protocol ID
Schulthess_Anä_10
Status last verified
Jan 2018
First submitted
20 Mar 2017
Last updated
8 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moser B, Keller C, Audige L, Dave MH, Bruppacher HR. Fiberoptic intubation of severely obese patients through supraglottic airway: A prospective, randomized trial of the Ambu(R) AuraGain laryngeal mask vs the i-gel airway. Acta Anaesthesiol Scand. 2019 Feb;63(2):187-194. doi: 10.1111/aas.13242. Epub 2018 Aug 8.

    PubMed 30088266

Questions about this trial

What is this clinical trial studying?

A study testing Ambu AuraGain and Intersurgical i-gel in people with Obese, run by Schulthess Klinik at 1 site in Switzerland.

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 4 inclusion and 11 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 8 Jan 2018. 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 Switzerland. 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?

Time of successful intubation (time frame: intraoperative). 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 NCT03110393, which also lists 1 linked publication.

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 8 Jan 2018; AzTrials last refreshed its copy on 4 Nov 2026.

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