Endotracheal Tube ExchangeBronchexNCT07706309
Bronchoscopic Versus Airway Exchange Catheter-Guided Endotracheal Tube Exchange
A study testing Airway Exchange Catheter-Guided Endotracheal Tube Exchange and Bronchoscope-Guided Endotracheal Tube Exchange in people with Endotracheal Tube Exchange and Airway Management, run by Léo Franchetti at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Tube Exchange, Airway Management, Endotracheal Intubation
- What is being tested?
- Airway Exchange Catheter-Guided Endotracheal Tube Exchange and Bronchoscope-Guided Endotracheal Tube Exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jul 2026to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Airway Exchange Catheter-Guided Endotracheal Tube Exchange, Bronchoscope-Guided Endotracheal Tube Exchange
- Keywords
- Airway exchange catheter, bronchoscopy, interventional pneumology, tube exchange, reintubation, endotracheal tube exchange, apnea time, airway management, critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Exchange Catheter-Guided Endotracheal Tube ExchangeProcedure or surgery
Also called Cook Catheter 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.
Bronchoscope-Guided Endotracheal Tube ExchangeProcedure or surgery
Also called Bronchoscopic 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.
| Study group | Role | What they receive |
|---|---|---|
| Airway Exchange Catheter | Active comparator | The body donors will undergo a tube exchange with the conventional airway exchange catheter-guided technique Receives: 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 Receives: Procedure: Bronchoscope-Guided Endotracheal Tube Exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation interruption time during endotracheal tube exchange
Time in seconds from interruption of ventilation until ventilation is resumed through the correctly positioned replacement tube
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start10 Jul 2026
- Primary completion10 Jul 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endotracheal Tube ExchangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Léo Franchetti
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Léo Franchetti, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706309
- Sponsor's protocol ID
- EKNZ 2026-01277
- Acronym
- Bronchex
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thiel W. [The preservation of the whole corpse with natural color]. Ann Anat. 1992 Jun;174(3):185-95. German.
PubMed 1503236Harris 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.
PubMed 21831436Corso 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.
PubMed 32154681McLean 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.
PubMed 24257382
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Endotracheal Tube Exchange as an Alternative to Airway Exchange Catheter-Guided Tube Exchange: A Prospective Study
- ClinicalTrials.gov ID
- NCT07706309
- Acronym / sponsor ID
- Bronchex / EKNZ 2026-01277
- Keywords
- Airway exchange catheter, bronchoscopy, interventional pneumology, tube exchange, reintubation, endotracheal tube exchange, apnea time, airway management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Léo FranchettiUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airway Exchange Catheter | Active comparator | Procedure: Airway Exchange Catheter-Guided Endotracheal Tube ExchangeThe body donors will undergo a tube exchange with the conventional airway exchange catheter-guided technique |
| Bronchoscopic tube exchange | Experimental | Procedure: Bronchoscope-Guided Endotracheal Tube ExchangeThe body donors will undergo a tube exchange with the bronchoscopic tube-exchange technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway Exchange Catheter-Guided Endotracheal Tube ExchangeAlso: Cook Catheter Tube ExchangeThe 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. | Procedure or surgery | Airway Exchange Catheter |
| Bronchoscope-Guided Endotracheal Tube ExchangeAlso: Bronchoscopic tube exchangeThe 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. | Procedure or surgery | Bronchoscopic tube exchange |
Primary outcome
Ventilation interruption time during endotracheal 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
5 secondary outcomes
Unsuccessful tube exchange requiring complete reintubation - number and proportion of exchanges in which the assigned technique is abandoned and full reintubation is required.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 1503236Thiel W. [The preservation of the whole corpse with natural color]. Ann Anat. 1992 Jun;174(3):185-95. German.
- Background: PubMed 21831436Harris 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.
- Background: PubMed 32154681Corso 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.
- Background: PubMed 24257382McLean 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway Exchange Catheter-Guided Endotracheal Tube Exchange and Bronchoscope-Guided Endotracheal Tube Exchange in people with Endotracheal Tube Exchange and Airway Management, run by Léo Franchetti at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation interruption time during endotracheal tube exchange (time frame: During each tube-exchange procedure, from ventilation interruption to resumption (expected duration less than 5 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07706309, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.