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Completed

NCT Number: NCT03110393

Ambu®AuraGain™ Versus I-gel® 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

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Key information

Conditions

Obese Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schulthess Klinik

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-sober patients (last meal <6 h)
  • Symptomatic reflux disease
  • Hiatus hernia
  • Significant cardiovascular risk factors
  • Severe COPD
  • Gastric band or gastric bypass
  • 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

Treatment and study plan

Ambu AuraGain

Device

Insert and intubation of an Ambu® AuraGain™ laryngeal mask

Intersurgical i-gel

Device

Insert and intubation of an Intersurgical i-gel®

Primary outcomes

  1. Time of successful intubation

    Time frame: intraoperative

    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.

Secondary outcomes

  1. Number of Insertions (of the laryngeal mask)

    Time frame: intraoperative

    Number of insertion attempts will be registered

  2. Time of insertion

    Time frame: intraoperative

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

  3. Number of insertion attempts

    Time frame: intraoperative

    Number of insertions with the stomach tube will be registered

  4. Gastric volume

    Time frame: intraoperative

    Measurement of the gastric volume

  5. Positioning of the gastric probe

    Time frame: intraoperative

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

  6. Successful Ventilation

    Time frame: intraoperative

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

  7. Oropharyngeal leak pressure of the Ambu®AuraGain ™

    Time frame: intraoperative

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

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

    Time frame: intraoperative

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

  9. Measurement of blood pressure

    Time frame: intraoperative

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

  10. Measurement of oxygen saturation

    Time frame: intraoperative

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

  11. Measurement of heart rate

    Time frame: intraoperative

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

  12. Maximum ventilation pressure

    Time frame: intraoperative

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

  13. Measurement CO2 (kPa):

    Time frame: intraoperative

    The exhaled CO2 is determined continuously.

  14. Number of intubation attempts

    Time frame: intraoperative

    The number of intubation attempts until successful intubation is recorded.

  15. Reasons for the unsuccessful intubation

    Time frame: intraoperative

    The reasons are listed in tabular form.

  16. Number of esophageal intubations

    Time frame: intraoperative

    The number of esophageal intubations is measured.

  17. Resistance (for an EET):

    Time frame: intraoperative

    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

  18. Location of the mask (Brimacombe)

    Time frame: intraoperative

    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.

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

    Time frame: 5hour postoperative

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

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

    Time frame: 5hour postoperative

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

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

    Time frame: 5hour postoperative

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

  22. Blood on laryngeal mask after intubation

    Time frame: intraoperative

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

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2017
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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