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

Not Applicable

• Conditions: General Anesthesia
• Interventions: Procedure: tracheal intubation

• Registration Number: NCT02002364
• Lead Sponsor: Rigshospitalet, Denmark

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2013-11-30
• Study First Posted: 2013-12-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single use flexible optical scope	tracheal intubation	Single use flexible optical scope , Ambu aScope
Multiple use flexible optical scope	tracheal intubation	Multiple use flexible optical scope

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (2)

Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre; 🇫🇷 Strasbourg, France

Rigshospitalet, Denmark; 🇩🇰 Copenhagen, Denmark