Administration of Local Anaesthetics With a Special Atomizing Set Durching Fexible Bronchoscopy
Conditions
Keywords
felxible bronchoscopy, anaesthetics, transcutaneous pCO2, capillary pCO2
Brief summary
The aim of this prospective study is to examine the benefits und risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.
Interventions
DEVICEEnk Fiberoptic Atomizer
Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the felxible bronchoscopy
DEVICEbronchoscope
Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the felxible bronchoscopy
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic purposes (suspected lung cancer, interstitial lung disease, unexplained pulmonary opacities) * hospitalized patients * patients aged 18 years or above * written informed consent prior to study participation
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of anaesthetics during fexible bronchoscopy | one hour | Valdiation of the total amount of administered propofol (mg) during the fexible bronchoscopy. Usage of sedatives other than propofol (midazolam), total amount of administered lidocaine, duration of bronchoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pCO2 | two hours | 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 |
Countries
Germany
Outcome results
None listed