Bronchoscopic Versus Airway Exchange Catheter-Guided Endotracheal Tube Exchange

NCT07706309 | Recruiting

• 1 other identifier: EKNZ 2026-01277
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endotracheal Tube Exchange; Airway Management; Endotracheal Intubation; Reintubation

Keywords

Airway exchange catheter; bronchoscopy; interventional pneumology; tube exchange; reintubation; endotracheal tube exchange; apnea time; airway management; critical care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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).

Study Arms (2)

Airway Exchange Catheter

ACTIVE COMPARATOR

The body donors will undergo a tube exchange with the conventional airway exchange catheter-guided technique

Procedure: Airway Exchange Catheter-Guided Endotracheal Tube Exchange

Bronchoscopic tube exchange

EXPERIMENTAL

The body donors will undergo a tube exchange with the bronchoscopic tube-exchange technique

Procedure: Bronchoscope-Guided Endotracheal Tube Exchange

Interventions

Airway Exchange Catheter-Guided Endotracheal Tube Exchange PROCEDURE

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.

Also known as: Cook Catheter Tube Exchange

Airway Exchange Catheter

Bronchoscope-Guided Endotracheal Tube Exchange PROCEDURE

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.

Also known as: Bronchoscopic tube exchange

Bronchoscopic tube exchange

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Léo Franchetti: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

Unversity Hospital of Basel

Basel, Switzerland

RECRUITING

Related Publications (4)

• Thiel W. [The preservation of the whole corpse with natural color]. Ann Anat. 1992 Jun;174(3):185-95. German.

  PMID: 1503236 BACKGROUND

• 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.

  PMID: 21831436 BACKGROUND

• 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.

  PMID: 32154681 BACKGROUND

• 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.

  PMID: 24257382 BACKGROUND

Central Study Contacts

Léo Franchetti, MD

CONTACT

+41 61 265 25 25; leo.franchetti@usb.ch

Prof. Jürgen Hetzel, MD

CONTACT

+41 61 328 61 95; juergen.hetzel@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, Department of Pneumology, University Hospital Basel

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 10, 2026
• Primary Completion: July 10, 2026
• Study Completion: July 10, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)