AirwayCT2TrachosprayNCT05478122
Soft Mist Spray Device for Airway Anaesthesia During Awake Videolaryngoscopy
A study testing Trachospray for awake videolaryngoscopy in people with Airway and Anesthesia, Local, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Effective and fast topical anaesthesia of the upper airway is of paramount importance in awake (conscious) videolaryngoscopy of the airway in order to avoid patient discomfort. Different methods of anesthetizing the airway have been described. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway, Anesthesia, Local
- What is being tested?
- Trachospray for awake videolaryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jul 2022to 11 Feb 2023
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-60 years
- Lean body weight >= 50 kg
- ASA physical status 1
Who cannot join
- Inability to cooperate with adequate airway assessment,
- History of hepatic, renal and coagulation diseases,
- Respiratory tract pathology
- Pregnancy
- Risk of regurgitation or aspiration
- Allergy to amide type of local anaesthetics
- No written informed consent by subject
Trial locations and contacts
1 site in 1 country.
About this study
Rationale:
Effective and fast topical anaesthesia of the upper airway is of paramount importance in awake (conscious) videolaryngoscopy of the airway in order to avoid patient discomfort. Different methods of anesthetizing the airway have been described. Conventional topical airway anaesthesia is not always effective due to non-optimal flow patterns and generation of ineffective local anaesthetic aerosols. Other methods of anaesthetizing the airway are more invasive. In order to optimize topical anaesthesia of the airway a soft mist spray device (Trachospray) for topical anaesthesia of the airway has been developed, in which optimal airflow patterns are obtained and local anaesthetic aerosols are generated which will reach the target zone for anesthetizing the airway.
Read more
Objective: In this study, the Trachospray will be used for awake videolaryngoscopy, to evaluate its use, effectiveness and comfort level for patients and anaesthesiologist.
Study design: Interventional study.
Study population: 20 healthy human volunteers, ASA 1, 18-60 years old.
Intervention: Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device
Main study parameters/endpoints:
Anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal discomfort for the subject.
Nature and extent of the burden and risks associated with participation:
Risk management on the Trachospray device shows that all user risks are mitigated and no residual risks remain for the use of the device. Testing of the device and the application of the device in daily practice has no additional risks than the present technique of performing anaesthesia of the airways.There may be some discomfort during the procedure, mainly airway irritation which may cause coughing or gag reflex.
- Conditions
- Airway, Anesthesia, Local
- Being tested
- Trachospray for awake videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trachospray for awake videolaryngoscopyDevice
Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device Receives: Device: Trachospray for awake videolaryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal discomfort for the subject
Discomfort and level of anesthesia will be measured with a numerical rating scale (NRS). 60 / 5.000 Vertaalresultaten So the result will be displayed in whole numbers.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start25 Jul 2022
- Primary completion11 Feb 2023
- Study completion11 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AirwayStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geert-Jan van Geffen, Principal investigator, Radboud University Medical Center (Radboudumc)Hielke Markerink, Study director, Radboud University Medical Center (Radboudumc)Jorgen Bruhn, Study chair, Radboud University Medical Center (Radboudumc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478122
- Sponsor's protocol ID
- CT2 Trachospray
- Acronym
- CT2Trachospray
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Mist Spray Device for Airway Anaesthesia During Awake Videolaryngoscopy
- ClinicalTrials.gov ID
- NCT05478122
- Acronym / sponsor ID
- CT2Trachospray / CT2 Trachospray
- Conditions
- Airway, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 11 Feb 2023 (actual)
- Study completion
- 11 Feb 2023 (actual)
- First posted
- 28 Jul 2022 (actual)
- 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.
Rationale:
Effective and fast topical anaesthesia of the upper airway is of paramount importance in awake (conscious) videolaryngoscopy of the airway in order to avoid patient discomfort. Different methods of anesthetizing the airway have been described. Conventional topical airway anaesthesia is not always effective due to non-optimal flow patterns and generation of ineffective local anaesthetic aerosols. Other methods of anaesthetizing the airway are more invasive. In order to optimize topical anaesthesia of the airway a soft mist spray device (Trachospray) for topical anaesthesia of the airway has been developed, in which optimal airflow patterns are obtained and local anaesthetic aerosols are generated which will reach the target zone for anesthetizing the airway.
Objective: In this study, the Trachospray will be used for awake videolaryngoscopy, to evaluate its use, effectiveness and comfort level for patients and anaesthesiologist.
Study design: Interventional study.
Study population: 20 healthy human volunteers, ASA 1, 18-60 years old.
Intervention: Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device
Main study parameters/endpoints:
Anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal discomfort for the subject.
Nature and extent of the burden and risks associated with participation:
Risk management on the Trachospray device shows that all user risks are mitigated and no residual risks remain for the use of the device. Testing of the device and the application of the device in daily practice has no additional risks than the present technique of performing anaesthesia of the airways.There may be some discomfort during the procedure, mainly airway irritation which may cause coughing or gag reflex.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Trachospray for awake videolaryngoscopySubjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-60 years
- Lean body weight >= 50 kg
- ASA physical status 1
Key exclusion criteria (7 listed)
- Inability to cooperate with adequate airway assessment,
- History of hepatic, renal and coagulation diseases,
- Respiratory tract pathology
- Pregnancy
- Risk of regurgitation or aspiration
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 |
|---|---|---|
| Trachospray for awake videolaryngoscopySubjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device | Device | Interventional |
Primary outcome
Complete anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal discomfort for the subject
Time frame: 3 months
Discomfort and level of anesthesia will be measured with a numerical rating scale (NRS). 60 / 5.000 Vertaalresultaten So the result will be displayed in whole numbers.
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 21 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Geert-Jan van Geffen principal investigator
Radboud University Medical Center (Radboudumc)
Hielke Markerink study director
Radboud University Medical Center (Radboudumc)
Jorgen Bruhn study chair
Radboud University Medical Center (Radboudumc)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trachospray for awake videolaryngoscopy in people with Airway and Anesthesia, Local, run by Radboud University Medical Center at 1 site in Netherlands.
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 7 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 21 Feb 2023. 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 Netherlands. 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?
Complete anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal discomfort for the subject (time frame: 3 months). 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 21 Feb 2023.