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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03411655
Other study ID # Schulthess_Anä_13
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 19, 2018
Last updated January 25, 2018
Start date March 2018
Est. completion date August 2018

Study information

Verified date January 2018
Source Schulthess Klinik
Contact Christian Keller, MD M.Sc.
Phone 0041 44 3857462
Email christian.keller@kws.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators test the hypothesis that fiberoptic intubation (time and success rate) differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric patients


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Months to 6 Years
Eligibility Inclusion Criteria:

- ASA I-II

- age 1.5 - 6 years

- minor surgery

- extraglottic airway device

Exclusion Criteria:

- age (<18 months, >6 years)

- weight (<10 kg, >20 kg)

- a known difficult airway

- risk of aspiration

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ambu Aura GainTM
Time and success rate
Ambu® Aura-ITM
Time and success rate

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Schulthess Klinik Medical University Innsbruck

Outcome

Type Measure Description Time frame Safety issue
Primary Fiberoptic intubation The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen) 5 minutes
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