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

Rigshospitalet

Status: Unknown

Conditions: General Anesthesia

Treatments: Procedure: tracheal intubation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02002364

Journal nr. H-3-2012-001

Details and patient eligibility

About

In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope.

We hypothesize that intubation is obtained equally effective with both types of flexible scopes

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Single use flexible optical scope

Active Comparator group

Description:

Single use flexible optical scope , Ambu aScope

Treatment:

Procedure: tracheal intubation

Multiple use flexible optical scope

Active Comparator group

Description:

Multiple use flexible optical scope

Treatment:

Procedure: tracheal intubation