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OpenTrials
Completed

NCT Number: NCT01969045

Effect of the EnkFiberoptic Atomizer Set on Usage of Anaesthetics During the Bronchoscopy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enk Fiberoptic Atomizer

Device

Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the felxible bronchoscopy

Other names: Enk Fiberoptic Atomizer Set, Cook Medical

bronchoscope

Device

Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the felxible bronchoscopy

Primary outcomes

  1. Amount of anaesthetics during fexible bronchoscopy

    Time frame: 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: EnkAtomizer

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2013
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.