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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01995292
Enrollment
100
Registered
2013-11-26
Start date
2013-10-31
Completion date
2014-10-31
Last updated
2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Awake Fiberoptic Intubation

Keywords

awake fiberoptic intubation, spray as you go technique, anesthesia, Enk Fiberoptic Atomizer Set

Brief 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.

Interventions

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comfort evaluation by the patientup to 4 weeksComparison of conventional and modified spray as you go technique

Secondary

MeasureTime frameDescription
Comfort evaluation by the performing as well as assisting anesthetistup to 4 weeksComparison of conventional and modified spray as you go technique
Comfort evaluation by the present nursesup to 4 weeksComparison of conventional and modified spray as you go technique
Patient response (coughing, gagging, grimacing, defenses)up to 4 weeksComparison of conventional and modified spray as you go technique
Vital signsup to 4 weeksComparison of conventional and modified spray as you go technique

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026