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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single use flexible optical scope

Single use flexible optical scope , Ambu aScope

Group Type ACTIVE_COMPARATOR

tracheal intubation

Intervention Type PROCEDURE

Multiple use flexible optical scope

Group Type ACTIVE_COMPARATOR

tracheal intubation

Intervention Type PROCEDURE

Interventions

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tracheal intubation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No