Clinical trial NCT02002364: Comparison of a Single Use (Ambu aScope) and a Reusable Flexible Optical Scope for Intubation Through a Supraglottic Airway Device (Aura-i)
Official title: A Comparison Between Flexible Single Use Endoscopes (Ambu aScopes) and Reusable Flexible Endoscopes Used as a Standard of Car When Intubation the Trachea Via an Aura-I Supraglottic Airway Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Keywords: tracheal intubation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Ambu A/S
First posted: 2013-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


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

Primary outcomes:
measure: Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen
timeFrame: Measured during tracheal intubation at induction of anesthesia
Secondary outcomes:
measure: Number of attempts at placing the supraglottic-airway-device (SAD)
timeFrame: From anesthesia induction and the following 10 minutes during securing of the airway
measure: number of attempts at placing the flexible endoscope in the trachea
timeFrame: From anesthesia induction and the following 10 minutes
measure: number of attempts at intubation
timeFrame: From anesthesia induction and during the following 10 minutes during airway management
measure: Total time for placement of SAD and endoscopy and intubation
timeFrame: During induction of anesthesia and the following 10 minutes during airway management
measure: The best glottic view obtained
timeFrame: After anesthesia induction and during the following 10 minutes during airway management
measure: The ease of passage of the flexible endoscope via the SAD
timeFrame: During induction and airway management
measure: The anesthesiologists' satisfaction with the procedure
timeFrame: During induction of anesthesia and within the 30 minutes hereafter
measure: The quality of the endoscopically obtained image
timeFrame: During induction of anesthesia and the following 10 minutes during airway management
measure: Postoperative sore throat, dysphonia or dysphagia one hour after extubation
timeFrame: AT the time 1 hour after extubation of the trachea
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Denmark
city: Strasbourg
country: France
facility: Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre
Study officials:
affiliation: Rigshospitalet, Denmark
name: Michael S Kristensen
role: PRINCIPAL_INVESTIGATOR
References: