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

Primary Purpose

Obese

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ambu AuraGain
Intersurgical i-gel
Sponsored by
Schulthess Klinik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese focused on measuring Obese, Laryngeal Mask Airway, Anaesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Schulthess Klinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ambu® AuraGain™

Intersurgical i-gel®

Arm Description

Intervention with Ambu® AuraGain™Laryngeal Mask

Intervention with Intersurgical i-gel® Laryngeal Mask

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Insertions (of the laryngeal mask)
Number of insertion attempts will be registered
Time of insertion
The time of Insertion of the laryngeal mask will be recorded.
Number of insertion attempts
Number of insertions with the stomach tube will be registered
Gastric volume
Measurement of the gastric volume
Positioning of the gastric probe
Determination of the position of the gastric probe after successful insertion by stethoscope.
Successful Ventilation
Detection of a successful Ventilation. There are two options: a tidal volume > 6mL/kg lean body mass or endtidal pCO2 < 6.7kPa
Oropharyngeal leak pressure of the Ambu®AuraGain ™
The oropharyngeal leak pressure of the AuraGain™ is measured with a measured cuff volume of 60cmH2O
Oropharyngeal leak pressure of the Intersurgical i-gel®
The oropharyngeal leak pressure of the Intersurgical i-gel® is measured.
Measurement of blood pressure
Measurement of blood pressure during 5min (1 measurement / minute).
Measurement of oxygen saturation
Measurement oxygen saturation during 5min (1 measurement / minute).
Measurement of heart rate
Measurement of heart rate during 5min (1 measurement / minute).
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
Measurement CO2 (kPa):
The exhaled CO2 is determined continuously.
Number of intubation attempts
The number of intubation attempts until successful intubation is recorded.
Reasons for the unsuccessful intubation
The reasons are listed in tabular form.
Number of esophageal intubations
The number of esophageal intubations is measured.
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
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.
Swallowing (no / little / medium / strong)
The swallowing difficulties are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Throat pain (no / little / medium / strong)
The throat pain is questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
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).
Blood on laryngeal mask after intubation
Determination of the visible blood on the laryngeal mask after removal (no, little, much).

Full Information

First Posted
March 20, 2017
Last Updated
January 5, 2018
Sponsor
Schulthess Klinik
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1. Study Identification

Unique Protocol Identification Number
NCT03110393
Brief Title
Ambu®AuraGain™ Versus I-gel® in Obese Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
September 6, 2017 (Actual)
Study Completion Date
September 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schulthess Klinik

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese
Keywords
Obese, Laryngeal Mask Airway, Anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambu® AuraGain™
Arm Type
Experimental
Arm Description
Intervention with Ambu® AuraGain™Laryngeal Mask
Arm Title
Intersurgical i-gel®
Arm Type
Active Comparator
Arm Description
Intervention with Intersurgical i-gel® Laryngeal Mask
Intervention Type
Device
Intervention Name(s)
Ambu AuraGain
Intervention Description
Insert and intubation of an Ambu® AuraGain™ laryngeal mask
Intervention Type
Device
Intervention Name(s)
Intersurgical i-gel
Intervention Description
Insert and intubation of an Intersurgical i-gel®
Primary Outcome Measure Information:
Title
Time of successful intubation
Description
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.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Number of Insertions (of the laryngeal mask)
Description
Number of insertion attempts will be registered
Time Frame
intraoperative
Title
Time of insertion
Description
The time of Insertion of the laryngeal mask will be recorded.
Time Frame
intraoperative
Title
Number of insertion attempts
Description
Number of insertions with the stomach tube will be registered
Time Frame
intraoperative
Title
Gastric volume
Description
Measurement of the gastric volume
Time Frame
intraoperative
Title
Positioning of the gastric probe
Description
Determination of the position of the gastric probe after successful insertion by stethoscope.
Time Frame
intraoperative
Title
Successful Ventilation
Description
Detection of a successful Ventilation. There are two options: a tidal volume > 6mL/kg lean body mass or endtidal pCO2 < 6.7kPa
Time Frame
intraoperative
Title
Oropharyngeal leak pressure of the Ambu®AuraGain ™
Description
The oropharyngeal leak pressure of the AuraGain™ is measured with a measured cuff volume of 60cmH2O
Time Frame
intraoperative
Title
Oropharyngeal leak pressure of the Intersurgical i-gel®
Description
The oropharyngeal leak pressure of the Intersurgical i-gel® is measured.
Time Frame
intraoperative
Title
Measurement of blood pressure
Description
Measurement of blood pressure during 5min (1 measurement / minute).
Time Frame
intraoperative
Title
Measurement of oxygen saturation
Description
Measurement oxygen saturation during 5min (1 measurement / minute).
Time Frame
intraoperative
Title
Measurement of heart rate
Description
Measurement of heart rate during 5min (1 measurement / minute).
Time Frame
intraoperative
Title
Maximum ventilation pressure
Description
The maximum ventilation pressure is measured, which must be applied in order to adequately ventilate the patients. This is measured over 5 minutes
Time Frame
intraoperative
Title
Measurement CO2 (kPa):
Description
The exhaled CO2 is determined continuously.
Time Frame
intraoperative
Title
Number of intubation attempts
Description
The number of intubation attempts until successful intubation is recorded.
Time Frame
intraoperative
Title
Reasons for the unsuccessful intubation
Description
The reasons are listed in tabular form.
Time Frame
intraoperative
Title
Number of esophageal intubations
Description
The number of esophageal intubations is measured.
Time Frame
intraoperative
Title
Resistance (for an EET):
Description
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
Time Frame
intraoperative
Title
Location of the mask (Brimacombe)
Description
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.
Time Frame
intraoperative
Title
Swallowing (no / little / medium / strong)
Description
The swallowing difficulties are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Time Frame
5hour postoperative
Title
Throat pain (no / little / medium / strong)
Description
The throat pain is questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Time Frame
5hour postoperative
Title
Hoarseness (no / little / medium / strong)
Description
The swallowing difficulties, the throat pain and the hoarseness are questioned preoperatively and postoperatively (5 (± 1) h after anesthesia end).
Time Frame
5hour postoperative
Title
Blood on laryngeal mask after intubation
Description
Determination of the visible blood on the laryngeal mask after removal (no, little, much).
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Berthold, MD
Organizational Affiliation
Schulthess Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schulthess Klinik
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30088266
Citation
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.
Results Reference
derived

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

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