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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Awake Fiberoptic Intubation | Device: bronchoscope Device: Enk Fiberoptic Atomizer | Not Applicable |
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 |
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 |
- Comfort evaluation by the patient [ Time Frame: up to 4 weeks ]Comparison of conventional and modified "spray as you go" technique
- 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
- Comfort evaluation by the present nurses [ Time Frame: up to 4 weeks ]Comparison of conventional and modified "spray as you go" technique
- Patient response (coughing, gagging, grimacing, defenses) [ Time Frame: up to 4 weeks ]Comparison of conventional and modified "spray as you go" technique
- Vital signs [ Time Frame: up to 4 weeks ]Comparison of conventional and modified "spray as you go" technique

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
Germany | |
Johannes Gutenberg - Universität | |
Mainz, Rhineland Palatinate, Germany, 55131 |
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 |
awake fiberoptic intubation spray as you go technique anesthesia Enk Fiberoptic Atomizer Set |
Anesthetics Anesthetics, Local Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |