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

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02002364
• Other study ID #: Journal nr. H-3-2012-001
• Status: Recruiting
• Phase: N/A
• First received: November 24, 2013
• Last updated: May 20, 2014
• Start date: November 2013

Study information

• Verified date: May 2014
• Source: Rigshospitalet, Denmark
• Contact: Michael S Kristensen, M.D.
• Phone: 0045 35458033
• Email: michael.seltz.kristensen[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Mental Health Services in the Capital Region of Denmark
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Procedure:
• tracheal intubation

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Denmark	Copenhagen
France	Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	AMBU

Countries where clinical trial is conducted

Denmark,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen		Measured during tracheal intubation at induction of anesthesia	No
Secondary	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	No
Secondary	number of attempts at placing the flexible endoscope in the trachea		From anesthesia induction and the following 10 minutes	No
Secondary	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	No
Secondary	Total time for placement of SAD and endoscopy and intubation		During induction of anesthesia and the following 10 minutes during airway management	No
Secondary	The best glottic view obtained		After anesthesia induction and during the following 10 minutes during airway management	No
Secondary	The ease of passage of the flexible endoscope via the SAD		During induction and airway management	No
Secondary	The anesthesiologists' satisfaction with the procedure		During induction of anesthesia and within the 30 minutes hereafter	No
Secondary	The quality of the endoscopically obtained image		During induction of anesthesia and the following 10 minutes during airway management	No
Secondary	Postoperative sore throat, dysphonia or dysphagia one hour after extubation		AT the time 1 hour after extubation of the trachea	No