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Prospective Comparison of Oral Intubation Via - Ambu® Aura Gain™ vs Slotted Guedel Tubus

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ClinicalTrials.gov Identifier: NCT02570269
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Berthold Moser, Schulthess Klinik

Brief Summary:
The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.

Condition or disease Intervention/treatment Phase
Adverse Anesthesia Outcome Procedure: AuraGain Procedure: Slotted Guedeltubus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison Between a Flexible Fiberoptic Intubation Via the Ambu® Aura Gain™ Airway and the Slotted Guedel Tubus in Terms of Time to a Completed Airway Management and Patient Safety.
Study Start Date : December 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: AuraGain
The patient will get a fiberoptic Intubation via the AuraGain larynxmask
Procedure: AuraGain
Fiberoptic Intubation

Placebo Comparator: Slotted Guedeltubus
The patient will get a fiberoptic intubation via the slotted Guedeltubus
Procedure: Slotted Guedeltubus
Fiberoptic Intubation




Primary Outcome Measures :
  1. Intubation time [ Time Frame: Intraoperative ]
    Time to complete the Intubation in seconds


Secondary Outcome Measures :
  1. Intubation attempts [ Time Frame: Intraoperative ]
    The number of intubation attempts will be recorded (eg 1, 2, 3...)

  2. Esophagal Intubation attempts [ Time Frame: Intraoperative ]
    The number of esophagal intubation attempts will be recorded (eg 1, 2, 3...)

  3. Resistance measurement of the Insertion as assessed by a four point scoring system [ Time Frame: Intraoperative ]
    1/2/3/4

  4. Position of the mask as assessed by the Brimacombe Score [ Time Frame: Intraoperative ]
    4/3/2/1

  5. Pain after Intubation as assessed by a Numeric Rating Scale [ Time Frame: Intraoperative/2h postoperative/24h postoperative ]
    mild/moderate/severe

  6. AE/Complications [ Time Frame: Intraoperative/postoperative until 24h ]
    Occuring AE/Complications will be recorded



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥18
  • ASA 1 -2
  • Surgery of the shoulder, elbow, hand, hip, knee or foot
  • Signed consent form

Exclusion Criteria:

  • Patients with expected difficulties regarding to the intubation
  • Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach
  • Not sober
  • Increased risk of aspiration
  • BMI > 35 kg/m2
  • Acute disease which could affect the suitability of the anesthesia
  • Patients in which the use of a laryngeal mask is contraindicated or otherwise not possible
  • Patients with a disease which prevents an accurate examination of the patients (eg neuromuscular, mentally, metabolic disease)
  • Drug abuse in the recent past
  • Legal incompetence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570269


Locations
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Switzerland
Schulthess Klinik
Zürich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
Investigators
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Principal Investigator: Berthold Moser, MD Schulthess Klinik
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Berthold Moser, Principal Investigator, Schulthess Klinik
ClinicalTrials.gov Identifier: NCT02570269    
Other Study ID Numbers: Schulthess_Anä_6
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2016