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

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

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 Overview

• Status: Unknown
• Conditions: General Anesthesia
• Intervention / Treatment: Procedure: tracheal intubation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet, Denmark
    • Contact: Michael S Kristensen, M.D.; Phone Number: 0045 3445 8033; Email: michael.seltz.kristensen@regionh.dk
    • Principal Investigator: Michael S Kristensen, M.D.
• France
  • Strasbourg, France, 67098
    • Not yet recruiting
    • Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre
    • Contact: Pierre Diemunsch, M.D.; Phone Number: 0033 3 88 12 70 76; Email: pierre.diemunsch@chrustrasbourg.fr
    • Principal Investigator: Pierre Diemunsch, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single use flexible optical scope; Single use flexible optical scope , Ambu aScope	Procedure: tracheal intubation
Active Comparator: Multiple use flexible optical scope	Procedure: tracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Ambu A/S
• Investigators: Principal Investigator: Michael S Kristensen, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 24, 2013
• First Submitted That Met QC Criteria: November 30, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Estimate): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: tracheal intubation
• Other Study ID Numbers: Journal nr. H-3-2012-001