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Not yet recruiting NCT07033702

Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope)

No phase Interventional Tracheotomy Patients Airway Management Airway Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Airway-Exchange Broncholaryngoscope (AEBLScope).
Who it may be relevant to
Registry conditions: Tracheotomy Patients, Airway Management, Airway Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Study Assessing the Feasibility and Safety of the Airway Exchange Broncholaryngoscope (AEBLScope) During Routine Tracheostomy Tube Exchanges

Overview

This pilot study evaluates the safety and feasibility of a novel airway exchange broncholaryngoscope (AEBLScope) during routine tracheostomy tube exchanges in chronically tracheostomy-dependent adult outpatients.

Detailed description

The AEBLScope is a modified disposable bronchoscope designed to allow for simultaneous visualization during airway tube exchanges. This prospective, single-arm pilot study will assess the safety, feasibility, and effectiveness of the AEBLScope in low-risk airway tube exchanges.

Interventions

  • Device Airway-Exchange Broncholaryngoscope (AEBLScope)
    Airway Exchange Broncholaryngoscope (AEBLScope) - A modified disposable flexible bronchoscope designed to allow visualization during airway tube exchange procedures.

Primary outcome measures

  • Feasibility - First-pass success rate of tracheostomy tube exchange using the AEBLScope [Time frame: During procedure, at time of intervention]
Secondary outcome measures (2)
  • Feasibility - Procedure duration [Time frame: During procedure, at time of intervention]
  • Safety - Procedural complications [Time frame: During procedure, at time of intervention]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Chronically (>1 month) tracheostomy-dependent outpatients
  • Currently not requiring ventilatory or supplemental oxygen support
  • Have undergone at least one prior tracheostomy tube exchange
  • Scheduled for routine in-office tracheostomy tube exchange
  • Able to provide informed consent

Exclusion criteria

  • Active respiratory infection
  • Patients with airway tubes having an inner diameter less than 6.0 mm
  • Patients with preexisting pulmonary conditions, including chronic obstructive pulmonary disease (COPD), restrictive lung disease, untreated pneumonia, or acute respiratory distress syndrome (ARDS)
  • Patients who are tracheostomy-dependent but cannot be orotracheally intubated.
  • Patients unable to provide informed consent and who have no legally authorized representative.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 2 centers
  • Keck Hospital of USC — Los Angeles
  • Los Angeles General Medical Center — Los Angeles

Publications

  • Roddy DJ, Spaeder MC, Pastor W, Stockwell DC, Klugman D. Unplanned Extubations in Children: Impact on Hospital Cost and Length of Stay. Pediatr Crit Care Med. 2015 Jul;16(6):572-5. doi: 10.1097/PCC.0000000000000406. PMID 25901542
  • Needham DM, Pronovost PJ. The importance of understanding the costs of critical care and mechanical ventilation. Crit Care Med. 2005 Jun;33(6):1434-5. doi: 10.1097/01.ccm.0000166360.82336.75. No abstract available. PMID 15942375
  • Tabaee A, Lando T, Rickert S, Stewart MG, Kuhel WI. Practice patterns, safety, and rationale for tracheostomy tube changes: a survey of otolaryngology training programs. Laryngoscope. 2007 Apr;117(4):573-6. doi: 10.1097/MLG.0b013e318030455a. PMID 17415123
  • 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
  • Mort TC. Continuous airway access for the difficult extubation: the efficacy of the airway exchange catheter. Anesth Analg. 2007 Nov;105(5):1357-62, table of contents. doi: 10.1213/01.ane.0000282826.68646.a1. PMID 17959966
  • Mort TC, Braffett BH. Conventional Versus Video Laryngoscopy for Tracheal Tube Exchange: Glottic Visualization, Success Rates, Complications, and Rescue Alternatives in the High-Risk Difficult Airway Patient. Anesth Analg. 2015 Aug;121(2):440-8. doi: 10.1213/ANE.0000000000000825. PMID 26111264
  • Ng J, Hohman MH, Agarwal A. Tracheostomy Tube Change. 2024 Feb 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555919/ PMID 32310379

Identifiers

NCT: NCT07033702 · 23-06016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗