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

NCT02002364 | Unknown

• 1 other identifier: Journal nr. H-3-2012-001
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

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

Conditions

General Anesthesia

Keywords

tracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Single use flexible optical scope

ACTIVE COMPARATOR

Single use flexible optical scope , Ambu aScope

Procedure: tracheal intubation

Multiple use flexible optical scope

ACTIVE COMPARATOR

Multiple use flexible optical scope

Procedure: tracheal intubation

Interventions

tracheal intubation PROCEDURE

Multiple use flexible optical scope; Single use flexible optical scope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Ambu A/S: collaborator

Study Sites (2)

Rigshospitalet, Denmark

Copenhagen, 2100, Denmark

RECRUITING

Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre

Strasbourg, 67098, France

NOT YET RECRUITING

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Michael S Kristensen

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael S Kristensen, M.D.

CONTACT

0045 35458033; michael.seltz.kristensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant anaesthetist

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 5, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

DK (1); FR (1)