In this study, the Trachospray device will be evaluated with regard to blocking the airway reflexes.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Complete anesthesia of the airway as evaluated and demonstrated by awake
laryngobronchoscopy with minimal discomfort for the subject.
Secondary outcome
None
Background summary
Effective and fast topical anesthesia of the upper airway is of paramount
importance in bronchoscopy, awake fiberoptic intubations and other
instrumentations of the airway in order to avoid patient discomfort. Different
methods of anesthetizing the airway have been described. However, conventional
topical airway anesthesia is not always effective due to non-optimal flow
patterns and generation of ineffective local anesthetic aerosols. Other methods
of anesthetizing the airway are more invasive.
In order to optimize topical anesthesia of the airway we constructed an
inhalation device (Trachospray) for topical anesthesia of the airway, in which
more optimal airflow patterns are obtained and local anesthetic aerosols are
generated which will reach the target zone for anesthetizing the airway.
Study objective
In this study, the Trachospray device will be evaluated with regard to blocking
the airway reflexes.
Study design
Observational study.
Intervention
Subjects will be asked to inhale (via the Trachospray device) 4 ml lidocaine
4%
Study burden and risks
Inevitably there is some discomfort during the procedure, mainly airway
irritation which causes coughing. Some post-procedural tracheal irritation
and/or hoarseness and a dry mouth for 3±4 h may occur.
Geert Grooteplein Zuid 10 Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10 Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Healthy ASA 1 patients between the age of 18 - 60 years old, with normal
anatomy of the airways
Exclusion criteria
Pregnancy, abnormal anatomy of the airways, allergy to amide type of local
anesthetics
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70682.091.19 |