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Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer During the Bronchoscopy (EnkAtomizerII)

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ClinicalTrials.gov Identifier: NCT02262442
Recruitment Status : Unknown
Verified February 2016 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : October 13, 2014
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief 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.

Condition or disease Intervention/treatment Phase
Flexible Bronchoscopy Device: Enk Fiberoptic Atomizer Device: bronchoscope Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer on Usage of Anaesthetics and Sedatives During the Bronchoscopy
Study Start Date : October 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: Working channel
Patients will receive local anaesthetics via the working channel of the bronchoscope.
Device: bronchoscope
Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy

Experimental: Enk Fiberoptic Atomizer
Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer.
Device: Enk Fiberoptic Atomizer
Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy
Other Name: Enk Fiberoptic Atomizer Set, Cook Medical




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. pCO2 [ Time Frame: 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




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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262442


Contacts
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Contact: Tobias Müller, Dr. med. +49 241 80 36470 tobmueller@ukaachen.de
Contact: Angela Habier, M.Sc. +49 241 80 37429 ahabier@ukaachen.de

Locations
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Germany
Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital Recruiting
Aachen, North Rhine-Westphalia, Germany, 52074
Contact: Tobias Müller, Dr. med.    +49 241 80 36470    tobmueller@ukaachen.de   
Contact: Angela Habier, M.Sc.    +49 241 80 37429    ahabier@ukaachen.de   
Principal Investigator: Tobias Müller, Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Tobias Müller, Dr. med. Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02262442    
Other Study ID Numbers: 14-074
EK 177/14 ( Other Identifier: Ethics Committee University Hospital Aachen )
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Keywords provided by RWTH Aachen University:
flexible bronchoscopy
anaesthetics
transcutaneous pCO2
capillary pCO2
special atomizing set