Awake Fiberoptic IntubationNCT01995292
Comparison of Two Different Types of "Spray as You go" Technique for Awake Fiberoptic Intubation
A study testing bronchoscope and Enk Fiberoptic Atomizer in people with Awake Fiberoptic Intubation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Awake Fiberoptic Intubation
- What is being tested?
- bronchoscope and Enk Fiberoptic Atomizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes Gutenberg - Universität
Mainz, Rhineland-Palatinate, 55131
About this study
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)
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.
- Conditions
- Awake Fiberoptic Intubation
- Being tested
- bronchoscope, Enk Fiberoptic Atomizer
- Keywords
- awake fiberoptic intubation, spray as you go technique, anesthesia, Enk Fiberoptic Atomizer Set
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopeDevice
Also called Standard procedure: Instillation of local anesthetics via the working channel of the bronchoscope
Enk Fiberoptic AtomizerDevice
Also called Nebulization of local anesthetics with the Enk Fiberoptic Atomizer during awake fiberoptic intubation
| Study group | Role | What they receive |
|---|---|---|
| bronchoscope | Experimental | Patients will receive local anaesthetics via the working channel of the bronchoscope. Receives: Device: bronchoscope |
| Enk Fiberoptic Atomizer | Experimental | Patients will receive local anaesthetics for the awake fiberoptic intubation via the Enk Fiberoptic Atomizer. Receives: Device: Enk Fiberoptic Atomizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort evaluation by the patient
Comparison of conventional and modified "spray as you go" technique
Measured: up to 4 weeks
Secondary outcomes (4)
Comfort evaluation by the performing as well as assisting anesthetist
Comparison of conventional and modified "spray as you go" technique
Measured: up to 4 weeks
Comfort evaluation by the present nurses
Comparison of conventional and modified "spray as you go" technique
Measured: up to 4 weeks
Patient response (coughing, gagging, grimacing, defenses)
Comparison of conventional and modified "spray as you go" technique
Measured: up to 4 weeks
Vital signs
Comparison of conventional and modified "spray as you go" technique
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake Fiberoptic IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995292
- Sponsor's protocol ID
- Atomizer1.0
- Status last verified
- Nov 2014
- First submitted
- 1 Nov 2013
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01995292
- Acronym / sponsor ID
- Atomizer1.0
- Conditions
- Awake Fiberoptic Intubation
- Keywords
- awake fiberoptic intubation, spray as you go technique, anesthesia, Enk Fiberoptic Atomizer Set
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchoscope | Experimental | Device: bronchoscopePatients will receive local anaesthetics via the working channel of the bronchoscope. |
| Enk Fiberoptic Atomizer | Experimental | Device: Enk Fiberoptic AtomizerPatients will receive local anaesthetics for the awake fiberoptic intubation via the Enk Fiberoptic Atomizer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- no concurrent participation in another clinical trial
- German language in speaking and writing
- Capability of giving consent
- written informed consent
Key exclusion criteria (6 listed)
- Age < 18 years
- pregnant women
- patients unwilling or unable to give informed consent
- ASA classification > 3
- Known allergy to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopeAlso: Standard procedure: Instillation of local anesthetics via the working channel of the bronchoscope | Device | bronchoscope |
| Enk Fiberoptic AtomizerAlso: Nebulization of local anesthetics with the Enk Fiberoptic Atomizer during awake fiberoptic intubation | Device | Enk Fiberoptic Atomizer |
Primary outcome
Comfort evaluation by the patient
Time frame: up to 4 weeks
Comparison of conventional and modified "spray as you go" technique
4 secondary outcomes
Comfort evaluation by the performing as well as assisting anesthetist
Time frame: up to 4 weeks
Comfort evaluation by the present nurses
Time frame: up to 4 weeks
Patient response (coughing, gagging, grimacing, defenses)
Time frame: up to 4 weeks
Vital signs
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscope and Enk Fiberoptic Atomizer in people with Awake Fiberoptic Intubation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort evaluation by the patient (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.