The Trachospray device gives complete anesthesia of the airway
ID
Bron
Verkorte titel
Aandoening
N/A
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Complete anesthesia of the airway as evaluated and demonstrated by awake laryngobronchoscopy with minimal discomfort for the subject.
Achtergrond van het onderzoek
Rationale:
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. 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 fine mist spray device (Trachospray) for topical anesthesia of the airway, in which optimal airflow patterns are obtained and local anesthetic aerosols are generated which will reach the target zone for anesthetizing the airway.
Objective: In this study, the Trachospray device will be evaluated to see if complete anesthesia of the airway can be obtained, to evaluate its use and comfort level for the subjects while used during awake laryngobronchoscopy.
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:
Complete anesthesia of the airway as evaluated and demonstrated by awake laryngobronchoscopy with minimal discomfort for the subject.
Nature and extent of the burden and risks associated with participation:
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.
Doel van het onderzoek
The Trachospray device gives complete anesthesia of the airway
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age between 18-60 years
- ASA physical status 1
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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 anesthetics
- No written informed consent by subject
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL8187 |
Ander register | CMO regio Arnhem-Nijmegen : 2019-5755 |