Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995292
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Awake Fiberoptic Intubation Device: bronchoscope Device: Enk Fiberoptic Atomizer Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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)
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: bronchoscope
Patients will receive local anaesthetics via the working channel of the bronchoscope.
 Device: bronchoscope
Other Name: 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 Name: Nebulization of local anesthetics with the Enk Fiberoptic Atomizer during awake fiberoptic intubation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Comfort evaluation by the patient [ Time Frame: up to 4 weeks ]
    Comparison of conventional and modified "spray as you go" technique


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995292


Locations
Layout table for location information
Germany
Johannes Gutenberg - Universität
Mainz, Rhineland Palatinate, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nina Pirlich, Dr. med., Dr. med. Nina Pirlich, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01995292    
Other Study ID Numbers: Atomizer1.0
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014
Keywords provided by Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz:
awake fiberoptic intubation
spray as you go technique
anesthesia
Enk Fiberoptic Atomizer Set
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents