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OpenTrials
Completed

NCT Number: NCT02570269

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

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.

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Key information

Conditions

Adverse Anesthesia Outcome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schulthess Klinik

Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

AuraGain

Procedure

Fiberoptic Intubation

Slotted Guedeltubus

Procedure

Fiberoptic Intubation

Primary outcomes

  1. Intubation time

    Time frame: Intraoperative

    Time to complete the Intubation in seconds

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Apr 16, 2019

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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