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

Study Overview
=================
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

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

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Procedure: tracheal intubation


Participation Criteria
=================
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: Modified Mallampati score > 2 (= no parts of the Uvula is visible) a thyromental distance of less then or equal to 6.5 cms Combined movement in head and neck < 90 degrees Mouth-opening less the 4 cm (but must be larger then 2.5 cm) Inability to protrude the teeth n the lower jaw beyond the upper incisors BMI > 40 combined with a neck-circumference > 43 cms Upper-lip-bite-test > 2 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single use flexible optical scope<br>Single use flexible optical scope , Ambu aScope | Procedure: tracheal intubation<br> <br> |
| Active Comparator: Multiple use flexible optical scope<br>Multiple use flexible optical scope | Procedure: tracheal intubation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts at placing the supraglottic-airway-device (SAD) | an attempt is defined as the tip of the SAD passing the upper front teeth | From anesthesia induction and the following 10 minutes during securing of the airway | 
| number of attempts at placing the flexible endoscope in the trachea |  | From anesthesia induction and the following 10 minutes | 
| number of attempts at intubation | An intubation attempt starts when the tip of the endotracheal tube passes the entrance to the SAD | From anesthesia induction and during the following 10 minutes during airway management | 
| 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 | 
| The ease of passage of the flexible endoscope via the SAD |  | During induction and airway management | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tracheal intubation