Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

10 juli 2026 uppdaterad av: Léo Franchetti

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

2

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

      • Basel, Schweiz
        • Rekrytering
        • Unversity Hospital of Basel
        • Kontakt:
          • Léo Franchetti, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Airway Exchange Catheter
The body donors will undergo a tube exchange with the conventional airway exchange catheter-guided technique
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.
Andra namn:
  • Cook Catheter Tube Exchange
Experimentell: Bronchoscopic tube exchange
The body donors will undergo a tube exchange with the bronchoscopic tube-exchange technique
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.
Andra namn:
  • Bronchoscopic tube exchange

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ventilation interruption time during endotracheal tube exchange
Tidsram: 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
During each tube-exchange procedure, from ventilation interruption to resumption (expected duration less than 5 minutes).

Sekundära resultatmått

Resultatmått
Tidsram
Unsuccessful tube exchange requiring complete reintubation - number and proportion of exchanges in which the assigned technique is abandoned and full reintubation is required.
Tidsram: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
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.
Tidsram: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
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.
Tidsram: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
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.
Tidsram: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
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.
Tidsram: Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).
Assessed during each tube-exchange procedure (approximately 5 minutes per procedure).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 juli 2026

Primärt slutförande (Beräknad)

10 juli 2026

Avslutad studie (Beräknad)

10 juli 2026

Studieregistreringsdatum

Först inskickad

10 juli 2026

Först inskickad som uppfyllde QC-kriterierna

10 juli 2026

Första postat (Faktisk)

15 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera