Bronchoscopic Versus Airway Exchange Catheter-Guided Endotracheal Tube Exchange (Bronchex)

Bronchoscopic Endotracheal Tube Exchange as an Alternative to Airway Exchange Catheter-Guided Tube Exchange: A Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Endotracheal Intubation; Airway Management; Reintubation; Endotracheal Tube Exchange
• Intervention / Treatment: Procedure: Airway Exchange Catheter-Guided Endotracheal Tube Exchange; Procedure: Bronchoscope-Guided Endotracheal Tube Exchange

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Léo Franchetti, MD; Phone Number: +41 61 265 25 25; Email: leo.franchetti@usb.ch
• Study Contact Backup: Name: Prof. Jürgen Hetzel, MD; Phone Number: +41 61 328 61 95; Email: juergen.hetzel@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • Recruiting
    • Unversity Hospital of Basel
    • Contact: Léo Franchetti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Human body donor preserved using the Thiel embalming method.
• Intact trachea without relevant postmortem or preparation-related lesions.
• Documented consent for scientific use of the body and confirmation of anatomical suitability by the Institute of Anatomy.
• Sufficient mobility of the neck, jaw, and laryngeal region to permit realistic tube-exchange maneuvers.

Exclusion Criteria:

• Tumor or stenosis involving the larynx, trachea, or central airways.
• Previous surgery or radiotherapy involving the larynx or oral cavity.
• Previous pneumonectomy.
• Previous tracheotomy or laryngectomy.
• Inability to achieve safe or standardized positioning of the cadaver.
• Incomplete consent documentation or unclear provenance.
• Preservation using a fixation method other than the Thiel method.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Airway Exchange Catheter; The body donors will undergo a tube exchange with the conventional airway exchange catheter-guided technique	Procedure: Airway Exchange Catheter-Guided Endotracheal Tube Exchange; 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
Experimental: Bronchoscopic tube exchange; The body donors will undergo a tube exchange with the bronchoscopic tube-exchange technique	Procedure: Bronchoscope-Guided Endotracheal 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation interruption time during endotracheal tube exchange	Time in seconds from interruption of ventilation until ventilation is resumed through the correctly positioned replacement tube	During each tube-exchange procedure, from ventilation interruption to resumption (expected duration less than 5 minutes).

Secondary Outcome Measures

Outcome Measure	Time Frame
Unsuccessful tube exchange requiring complete reintubation - number and proportion of exchanges in which the assigned technique is abandoned and full reintubation is required.	Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Duration of individual procedural steps - time in seconds for predefined components, including preparation and tube advancement.	Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Tube exchanges lasting more than 60 seconds - number and proportion of procedures with ventilation interruption exceeding 60 seconds.	Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Use of additional rescue equipment - number and proportion of exchanges requiring an additional device, such as a laryngoscope.	Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Unforeseen technical difficulties - type and frequency of technical problems not predefined in the protocol.	Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).

Collaborators and Investigators

• Sponsor: Léo Franchetti
• Collaborators: University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• McLean S, Lanam CR, Benedict W, Kirkpatrick N, Kheterpal S, Ramachandran SK. Airway exchange failure and complications with the use of the Cook Airway Exchange Catheter(R): a single center cohort study of 1177 patients. Anesth Analg. 2013 Dec;117(6):1325-7. doi: 10.1213/ANE.0b013e3182a7cd3d.
• Thiel W. [The preservation of the whole corpse with natural color]. Ann Anat. 1992 Jun;174(3):185-95. German.
• Harris K, Chalhoub M, Maroun R, Elsayegh D. Endotracheal tube exchangers: should we look for safer alternatives? Heart Lung. 2012 Jan-Feb;41(1):67-9. doi: 10.1016/j.hrtlng.2011.06.005. Epub 2011 Aug 10.
• Corso RM, Sorbello M, Mecugni D, Seligardi M, Piraccini E, Agnoletti V, Gamberini E, Maitan S, Petitti T, Cataldo R. Safety and efficacy of Staged Extubation Set in patients with difficult airway: a prospective multicenter study. Minerva Anestesiol. 2020 Aug;86(8):827-834. doi: 10.23736/S0375-9393.20.14105-1. Epub 2020 Mar 6.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: critical care; bronchoscopy; airway management; reintubation; apnea time; Airway exchange catheter; interventional pneumology; tube exchange; endotracheal tube exchange
• Other Study ID Numbers: EKNZ 2026-01277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No