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OpenTrials
Completed

NCT Number: NCT01995292

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

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.

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Key information

Conditions

Awake Fiberoptic Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bronchoscope

Device

Other names: Standard procedure: Instillation of local anesthetics via the working channel of the bronchoscope

Enk Fiberoptic Atomizer

Device

Other names: Nebulization of local anesthetics with the Enk Fiberoptic Atomizer during awake fiberoptic intubation

Primary outcomes

  1. Comfort evaluation by the patient

    Time frame: up to 4 weeks

    Comparison of conventional and modified "spray as you go" technique

Secondary outcomes

  1. Comfort evaluation by the performing as well as assisting anesthetist

    Time frame: up to 4 weeks

    Comparison of conventional and modified "spray as you go" technique

  2. Comfort evaluation by the present nurses

    Time frame: up to 4 weeks

    Comparison of conventional and modified "spray as you go" technique

  3. Patient response (coughing, gagging, grimacing, defenses)

    Time frame: up to 4 weeks

    Comparison of conventional and modified "spray as you go" technique

  4. Vital signs

    Time frame: up to 4 weeks

    Comparison of conventional and modified "spray as you go" technique

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2013
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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