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Search / Trial NCT02002364

Comparison of a Single Use (Ambu aScope) and a Reusable Flexible Optical Scope for Intubation Through a Supraglottic Airway Device (Aura-i)

Launched by RIGSHOSPITALET, DENMARK · Nov 30, 2013

Trial Information

Current as of June 08, 2025

Unknown status

Keywords

Tracheal Intubation

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ASA physical status 1-3 and evaluated pre-operatively and found suitable for tracheal intubation with a flexible optical scope via the SAD and scheduled for elective surgery/anesthesia and are conscious about their rights and consequences of participating in the study.
  • * The patient must have one or two of the following predictors of difficult tracheal intubation:
  • 1. Modified Mallampati score \> 2 (= "no parts of the Uvula is visible")
  • 2. a thyromental distance of less then or equal to 6.5 cms
  • 3. Combined movement in head and neck \< 90 degrees
  • 4. Mouth-opening less the 4 cm (but must be larger then 2.5 cm)
  • 5. Inability to protrude the teeth n the lower jaw beyond the upper incisors
  • 6. BMI \> 40 combined with a neck-circumference \> 43 cms
  • 7. Upper-lip-bite-test \> 2
  • 8. Previous difficult intubation or laryngoscopy (If more then two criteria are fulfilled the patient should be considered intubated awake instead. . But the upper-lip-bite-test and the prognation-beyond the incisors test represents a similar thing, namely the inability to sub-luxate the lower jaw, the if both these findings are positive it is only considered as counting for one.
  • Exclusion Criteria:
  • ASA physical status 4 or 5
  • contraindications for use of the SAD
  • Patients in whom intubation via a SAD has previously failed
  • Patients at risk of aspiration from the gastrointestinal channel
  • diseases in mouth, pharynx or larynx that precludes the use of a SAD
  • Patients in whom the cricothyroid membrane cannot be localized preanaesthetically
  • Patients in whom the doctor making the pre-anaesthetic evaluation finds in need of an awake intubation
  • Patients with possible Creutzfeldt-Jacobs disease or contraindication against the use of non-autoclavable equipment r risk of cross contamination with prions

About Rigshospitalet, Denmark

Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.

Locations

Copenhagen, , Denmark

Strasbourg, , France

Patients applied

0 patients applied

Trial Officials

Michael S Kristensen

Principal Investigator

Rigshospitalet, Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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