NCT02002364UnknownNot Applicable
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
Rigshospitalet, Denmark2 sites in 2 countries100 target enrollmentStarted: November 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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:
- •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
Arms & Interventions
Single use flexible optical scope
Active Comparator
Single use flexible optical scope , Ambu aScope
Intervention: tracheal intubation (Procedure)
Multiple use flexible optical scope
Active Comparator
Multiple use flexible optical scope
Intervention: tracheal intubation (Procedure)
Outcomes
Primary Outcomes
Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen
Time Frame: Measured during tracheal intubation at induction of anesthesia
Secondary Outcomes
- Number of attempts at placing the supraglottic-airway-device (SAD)(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(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)
Investigators
Michael Seltz Kristensen
Consultant anaesthetist
Rigshospitalet, Denmark
Study Sites (2)
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