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)
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 6, 2014
November 1, 2014
1 year
November 1, 2013
November 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comfort evaluation by the patient
Comparison of conventional and modified "spray as you go" technique
up to 4 weeks
Secondary Outcomes (4)
Comfort evaluation by the performing as well as assisting anesthetist
up to 4 weeks
Comfort evaluation by the present nurses
up to 4 weeks
Patient response (coughing, gagging, grimacing, defenses)
up to 4 weeks
Vital signs
up to 4 weeks
Study Arms (2)
bronchoscope
EXPERIMENTALPatients will receive local anaesthetics via the working channel of the bronchoscope.
Enk Fiberoptic Atomizer
EXPERIMENTALPatients will receive local anaesthetics for the awake fiberoptic intubation via the Enk Fiberoptic Atomizer.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johannes Gutenberg - Universität
Mainz, Rhineland-Palatinate, 55131, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Nina Pirlich
Study Record Dates
First Submitted
November 1, 2013
First Posted
November 26, 2013
Study Start
October 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 6, 2014
Record last verified: 2014-11