Comparison of Two Different Types of "Spray as You go" Technique for Awake Fiberoptic Intubation

Awake Fiberoptic Intubation Clinical Trial

Official title:

Comparative Clinical Trial of Conventional and Modified "Spray as You go" Technique With the "Enk Fiberoptic Atomizer Set" for Awake Fiberoptic Intubation (Atomizer Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995292
• Other study ID #: Atomizer1.0
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: November 5, 2014
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether modified "spray as you go" technique using the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for the patient.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Age =18 years

• no concurrent participation in another clinical trial

• German language in speaking and writing

• Capability of giving consent

• written informed consent

• an elective surgery under general anesthesia, in which an awake fiberoptic intubation is indicated

Exclusion Criteria:

• Age < 18 years

• pregnant women

• patients unwilling or unable to give informed consent

• ASA classification > 3

• Known allergy to local anesthetics

• Participation in another clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Awake Fiberoptic Intubation

Intervention

Device:
• bronchoscope

• Enk Fiberoptic Atomizer

Locations

Country	Name	City	State
Germany	Johannes Gutenberg - Universität	Mainz	Rhineland Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort evaluation by the patient	Comparison of conventional and modified "spray as you go" technique	up to 4 weeks	No
Secondary	Comfort evaluation by the performing as well as assisting anesthetist	Comparison of conventional and modified "spray as you go" technique	up to 4 weeks	No
Secondary	Comfort evaluation by the present nurses	Comparison of conventional and modified "spray as you go" technique	up to 4 weeks	No
Secondary	Patient response (coughing, gagging, grimacing, defenses)	Comparison of conventional and modified "spray as you go" technique	up to 4 weeks	No
Secondary	Vital signs	Comparison of conventional and modified "spray as you go" technique	up to 4 weeks	No