General Anesthesia
Conditions
Keywords
tracheal intubation
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
Interventions
PROCEDUREtracheal intubation
Sponsors
Ambu A/S
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen | Measured during tracheal intubation at induction of anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of attempts at placing the flexible endoscope in the trachea | From anesthesia induction and the following 10 minutes | — |
| number of attempts at intubation | From anesthesia induction and during the following 10 minutes during airway management | An intubation attempt starts when the tip of the endotracheal tube passes the entrance to the SAD |
| Total time for placement of SAD and endoscopy and intubation | During induction of anesthesia and the following 10 minutes during airway management | — |
| The best glottic view obtained | After anesthesia induction and during the following 10 minutes during airway management | — |
| Number of attempts at placing the supraglottic-airway-device (SAD) | From anesthesia induction and the following 10 minutes during securing of the airway | an attempt is defined as the tip of the SAD passing the upper front teeth |
| The anesthesiologists' satisfaction with the procedure | During induction of anesthesia and within the 30 minutes hereafter | — |
| The quality of the endoscopically obtained image | During induction of anesthesia and the following 10 minutes during airway management | — |
| Postoperative sore throat, dysphonia or dysphagia one hour after extubation | AT the time 1 hour after extubation of the trachea | — |
| The ease of passage of the flexible endoscope via the SAD | During induction and airway management | — |
Countries
Denmark, France
Contacts
Primary ContactMichael S Kristensen, M.D.
Outcome results
None listed