Flexible BronchoscopyPhase 4EnkAtomizerIINCT02262442
Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer During the Bronchoscopy
A Phase 4 study testing Enk Fiberoptic Atomizer and bronchoscope in people with Flexible Bronchoscopy, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of this prospective study is to examine the benefits and risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Flexible Bronchoscopy
- What is being tested?
- Enk Fiberoptic Atomizer and bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Aug 2016
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic purposes (seed extraction in unclear infiltrates, interstitial lung disease, unexplained pulmonary opacities, inspection at hemoptysis)
- patients aged 18 years or above
- written informed consent prior to study participation
Who cannot join
- known allergy to local anesthetics, midazolam or propofol, known epilepsy, known severe neurological or psychiatric disorder, hemodynamic instability with need for vasopressor therapy, acute or chronic decompensated heart failure, respiratory failure with the need for oxygen supplementation of more than 2 l per minute at rest (pO2 > 55 mmHg) or pCO2 > 50 mmHg at ambient air, known upper airway anomalies, surgery or irradiation of the upper airways in the past, contraindication for transbronchial biopsy as published by international guidelines, e. g. bleeding disorders or severe pulmonary hypertension
- women, who are pregnant or breastfeeding
- alcohol or drug abuse
- expected non-compliance
- patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
- Participation on another clinical trial within the last 3 months
- subjects who are committed to an institution and/or penitentiary by judicial or official order.
- employees of the investigator cooperation companies.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
Tobias Müller, Dr. med., +49 241 80 36470, tobmueller@ukaachen.de
Angela Habier, M.Sc., +49 241 80 37429, ahabier@ukaachen.de
About this study
Official title: Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer on Usage of Anaesthetics and Sedatives During the Bronchoscopy
The aim of this prospective study is to examine the benefits and risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.
- Conditions
- Flexible Bronchoscopy
- Being tested
- Enk Fiberoptic Atomizer, bronchoscope
- Keywords
- flexible bronchoscopy, anaesthetics, transcutaneous pCO2, capillary pCO2, special atomizing set
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enk Fiberoptic AtomizerDevice
Also called Enk Fiberoptic Atomizer Set, Cook Medical
Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy
bronchoscopeDevice
Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Working channel | Experimental | Patients will receive local anaesthetics via the working channel of the bronchoscope. Receives: Device: bronchoscope |
| Enk Fiberoptic Atomizer | Experimental | Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer 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.
Amount of anaesthetics during flexible bronchoscopy
Validation of the total amount of administered propofol (mg) during the flexible bronchoscopy.
Usage of sedatives other than propofol (midazolam), total amount of administered lidocaine, duration of bronchoscopy.
Measured: one hour
Secondary outcomes (1)
pCO2
Determination of:
maximum transcutaneous pCO2 during bronchoscopy, mean transcutaneous pCO2 during bronchoscopy, capillary pCO2 immediately after bronchoscopy and 2 hours later, time to Aldrete Score of at least 9 after procedure
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Flexible BronchoscopyStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Müller, Dr. med., Principal investigator, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262442
- Sponsor's protocol ID
- 14-074
- Other IDs
- EK 177/14
- Acronym
- EnkAtomizerII
- Status last verified
- Feb 2016
- First submitted
- 7 Oct 2014
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller T, Cornelissen C, Dreher M. Nebulization versus standard application for topical anaesthesia during flexible bronchoscopy under moderate sedation - a randomized controlled trial. Respir Res. 2018 Nov 21;19(1):227. doi: 10.1186/s12931-018-0926-5.
PubMed 30463577
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer on Usage of Anaesthetics and Sedatives During the Bronchoscopy
- ClinicalTrials.gov ID
- NCT02262442
- Acronym / sponsor ID
- EnkAtomizerII / 14-074
- Conditions
- Flexible Bronchoscopy
- Keywords
- flexible bronchoscopy, anaesthetics, transcutaneous pCO2, capillary pCO2, special atomizing set
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 13 Oct 2014 (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 aim of this prospective study is to examine the benefits and risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working channel | Experimental | Device: bronchoscopePatients will receive local anaesthetics via the working channel of the bronchoscope. |
| Enk Fiberoptic Atomizer | Experimental | Device: Enk Fiberoptic AtomizerPatients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic purposes (seed extraction in unclear infiltrates, interstitial lung disease, unexplained pulmonary opacities, inspection at hemoptysis)
- patients aged 18 years or above
- written informed consent prior to study participation
Key exclusion criteria (8 listed)
- known allergy to local anesthetics, midazolam or propofol, known epilepsy, known severe neurological or psychiatric disorder, hemodynamic instability with need for vasopressor therapy, acute or chronic decompensated heart failure, respiratory failure with the need for oxygen supplementation of more than 2 l per minute at rest (pO2 > 55 mmHg) or pCO2 > 50 mmHg at ambient air, known upper airway anomalies, surgery or irradiation of the upper airways in the past, contraindication for transbronchial biopsy as published by international guidelines, e. g. bleeding disorders or severe pulmonary hypertension
- women, who are pregnant or breastfeeding
- alcohol or drug abuse
- expected non-compliance
- patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
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 |
|---|---|---|
| Enk Fiberoptic AtomizerAlso: Enk Fiberoptic Atomizer Set, Cook MedicalNebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy | Device | Enk Fiberoptic Atomizer |
| bronchoscopeStandard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy | Device | Working channel |
Primary outcome
Amount of anaesthetics during flexible bronchoscopy
Time frame: one hour
Validation of the total amount of administered propofol (mg) during the flexible bronchoscopy. Usage of sedatives other than propofol (midazolam), total amount of administered lidocaine, duration of bronchoscopy.
1 secondary outcome
pCO2
Time frame: two hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Derived from this study: PubMed 30463577Muller T, Cornelissen C, Dreher M. Nebulization versus standard application for topical anaesthesia during flexible bronchoscopy under moderate sedation - a randomized controlled trial. Respir Res. 2018 Nov 21;19(1):227. doi: 10.1186/s12931-018-0926-5.
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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.
Tobias Müller, Dr. med. principal investigator
Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enk Fiberoptic Atomizer and bronchoscope in people with Flexible Bronchoscopy, run by RWTH Aachen University 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Feb 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Müller, Dr. med. (+49 241 80 36470, tobmueller@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of anaesthetics during flexible bronchoscopy (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262442, which also lists 1 linked publication.
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 18 Feb 2016.