Unversity Hospital of Basel
Basel, Switzerland
Location status: Recruiting
Location contact
Léo Franchetti, MD
CONTACT
NCT Number: NCT07706309
This prospective experimental study compares two methods for replacing an endotracheal tube in Thiel-embalmed body donors. The conventional method uses an airway exchange catheter based on the Seldinger technique, whereas the investigational method uses a flexible bronchoscope to provide direct visual guidance throughout the exchange.
The primary outcome is the duration of interrupted ventilation, measured from cessation of ventilation until ventilation is resumed through a correctly positioned replacement tube. Secondary outcomes include unsuccessful tube exchange requiring complete reintubation, duration of individual procedural steps, procedures lasting more than 60 seconds, use of additional rescue equipment, and unforeseen technical difficulties.
Both techniques will be performed in two Thiel-embalmed donated human bodies using an alternating sequence. Four experienced physicians will perform 40 tube exchanges per technique, resulting in a total of 80 procedures.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Basel, Switzerland
Location status: Recruiting
Léo Franchetti, MD
CONTACT
Endotracheal tube exchange may be required because of cuff failure, inappropriate tube size, tube damage, luminal obstruction, or the need for a planned intervention. During conventional tube exchange over an airway exchange catheter, continuous visualization of the subglottic airway and trachea is not possible. Consequently, advancement of the replacement tube may fail or may result in airway injury.
The bronchoscopic tube-exchange technique is intended to provide continuous visual control throughout the procedure and immediate confirmation of the replacement tube position.
The study will be conducted using two human bodies donated for medical education and research and preserved using the Thiel embalming method. Before each experimental series, the donated body will be intubated with a 7.5-mm endotracheal tube, and tracheobronchial secretions will be suctioned.
Two experienced physicians in intensive care medicine and anesthesiology will perform the conventional airway exchange catheter-guided technique, and two experienced pulmonologists will perform the bronchoscopic technique. To minimize order, learning, and tissue-wear effects, the techniques will be alternated. The starting technique will differ between the two body donors.
Each physician will perform 10 tube exchanges per body donor using the assigned technique, resulting in 20 procedures per physician, 40 procedures per technique, and 80 procedures overall.
Procedure timing will be based on predefined start and end points. The primary interval begins when ventilation is interrupted and ends when ventilation is resumed through the correctly positioned replacement tube. A trained observer will record procedural times, individual procedural steps, technical difficulties, use of additional equipment, and unsuccessful exchanges using a standardized source document.
Where feasible, video or photographic documentation may be used to verify procedure timing and technical events. The face will remain covered to prevent identification of the body donor.
Continuous outcomes will be analyzed using the paired Wilcoxon signed-rank test. Paired dichotomous outcomes will be analyzed using the McNemar test. Descriptive statistics will include medians, interquartile ranges, and ranges.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The existing tube fixation is released. A Cook airway exchange catheter is advanced through the in-situ endotracheal tube into the tracheobronchial tree. Ventilation is interrupted, the cuff is deflated, and the old tube is removed over the catheter. A new endotracheal tube is advanced over the catheter, the catheter is removed, the cuff is inflated, ventilation is resumed, and tube position is verified by lung auscultation.
Other names: Cook Catheter Tube Exchange
The replacement tube is preloaded onto a therapeutic flexible bronchoscope. The bronchoscope is advanced alongside the in-situ tube through the larynx into the trachea, and proximal tracheal secretions are suctioned. Ventilation is interrupted and the old tube is removed. The replacement tube is advanced over the bronchoscope into the trachea under direct visual control. The bronchoscope is removed, the cuff is inflated, and ventilation is resumed.
Other names: Bronchoscopic tube exchange
Time frame: During each tube-exchange procedure, from ventilation interruption to resumption (expected duration less than 5 minutes).
Time in seconds from interruption of ventilation until ventilation is resumed through the correctly positioned replacement tube
Time frame: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Time frame: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Time frame: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Time frame: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Time frame: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Contact information is provided by the study sponsor or research team.
Léo Franchetti, MD
CONTACT
Prof. Jürgen Hetzel, MD
CONTACT
Léo Franchetti
Other
Bronchoscopic Endotracheal Tube Exchange as an Alternative to Airway Exchange Catheter-Guided Tube Exchange: A Prospective Study
Acronym: Bronchex
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.
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