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

November 5, 2014 updated by: Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rhineland Palatinate
      • Mainz, Rhineland Palatinate, Germany, 55131
        • Johannes Gutenberg - Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bronchoscope
Patients will receive local anaesthetics via the working channel of the bronchoscope.
Device: bronchoscope
Other Names:
  • Standard procedure: Instillation of local anesthetics via the working channel of the bronchoscope
Experimental: Enk Fiberoptic Atomizer
Patients will receive local anaesthetics for the awake fiberoptic intubation via the Enk Fiberoptic Atomizer.
Device: Enk Fiberoptic Atomizer
Other Names:
  • Nebulization of local anesthetics with the Enk Fiberoptic Atomizer during awake fiberoptic intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort evaluation by the patient
Time Frame: up to 4 weeks
Comparison of conventional and modified "spray as you go" technique
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 4 weeks
Comfort evaluation by the present nurses
Time Frame: up to 4 weeks
Comparison of conventional and modified "spray as you go" technique
up to 4 weeks
Patient response (coughing, gagging, grimacing, defenses)
Time Frame: up to 4 weeks
Comparison of conventional and modified "spray as you go" technique
up to 4 weeks
Vital signs
Time Frame: up to 4 weeks
Comparison of conventional and modified "spray as you go" technique
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atomizer1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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