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High-Frequency Jet VentilationNCT06285994

Complications of High Frequency Jet Ventilation

An observational study of High-Frequency Jet Ventilation and Bronchoscopy, run by Erasme University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High-Frequency Jet Ventilation, Bronchoscopy
What is being tested?
High frequency jet ventilation
Type of treatment
Surgery or procedure
How many people
1,385 participants
Where
1 siteBelgium
Study dates
3 Mar 2024to 1 Feb 2025
Phase
Observational
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

Study population: All patients who underwent a bronchoscopy with the use of high frequency jet ventilation

Who may be able to join

  • All patients who underwent a bronchoscopy with the use of high frequency jet ventilation between January 1st, 2019 and December 31st, 2023 at Erasme University Hospital, Brussels

Who cannot join

  • Incomplete medical chart
  • Patient who expressed their opposition to the use of their medical data

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Hôpital Universitaire de Bruxelles - Hôpital erasme

    Brussels, 1070

Other trials in Belgium

About this study

Official title: Complications of High Frequency Jet Ventilation During Bronchoscopy - a Retrospective Cohort Study

High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:

  • Hypoxia: SpO2 < 90% for 1 min
  • Severe hypoxia: SpO2 < 85% for 1 min
  • Hemodynamic instability, defined as Arterial pressure < 90/60
  • Cardiac arrhythmia
  • Laryngospasm or bronchospasm
  • Barotrauma or volutrauma
  • Need for ICU admission
Read more

A model predicting the risk for developing any complication will be developped using 2 mathematical methods:

  • a multivariate analysis
  • a data mining approach

For both approaches, the following variables will be included in the model:

  • Age
  • Gender
  • Weight
  • Height
  • BMI
  • Smoking
  • Alcohol consumption
  • Consumption of Other drugs
  • ASA class
  • Obstructive pulmonary disease
  • Restrictive lung disease
  • COPD status (1, 2, 3, 4)
  • Interstitial lung disease
  • Lung tumor
  • Trachea location
  • Carina location
  • Bronchial location
  • Pulmonary or tracheal stenosis
  • Presence of stridor
  • Severe stenosis (< 6 mm)
  • Baseline SpO2 (pre-intervention)
  • Pre-intervention oxygen requirement Procedure
  • Duration (min)
  • Stent placement
  • Dilation
  • Laser treatment
  • Length of hospital stay Lung function tests
  • FEV1 (forced expiratory volume)
  • VC (Vital Capacity)
  • FEV1/VC (Tiffeneau ratio)
  • CPT (total lung capacity)
  • DLCO (carbon monoxide diffusion)
Being tested
High frequency jet ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High frequency jet ventilationProcedure or surgery

    Use of high frequency jet ventilation during bronchoscopy

Study groups in NCT06285994
Study groupRoleWhat they receive
HFJVAll patients who underwent bronchoscopy with the use of high frequency jet ventilation between January 1st 2019 and december 31st 2023.
Receives: Procedure: High frequency jet ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of complications

    The occurence (%) of complications of HFJV will be analyzed. Definition of complications is one or more of the following events:

    • Hypoxia: SpO2 < 90% for 1 min (%)
    • Severe hypoxia: SpO2 < 85% for 1 min (%)
    • Hemodynamic instability, defined as Arterial pressure < 90/60 (%)
    • Cardiac arrhythmia (%)
    • Laryngospasm or bronchospasm (%)
    • Barotrauma or volutrauma (%)
    • Need for ICU admission (%)

    Complications will be reported as overall complications (%) defined as the occurence of one or more of the listed events.

    Frequency of single events will be reported separately (%). Descriptive statistics ( %, mean, standard deviation, median, interquartile range) will be used as appropriate.

    Measured: 6 hours

Secondary outcomes (1)

  1. Prediction model of complications

    A model predicting the risk for developing any complication will be developped using 2 mathematical methods:

    • a multivariate analysis
    • a data mining approach

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start3 Mar 2024
  3. Primary completion19 Mar 2024
  4. Study completion1 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06285994
Sponsor's protocol ID
SRB2024016
Status last verified
May 2025
First submitted
12 Feb 2024
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aravena C, Mehta AC, Almeida FA, Lamb C, Maldonado F, Gildea TR. Innovation in rigid bronchoscopy-past, present, and future. J Thorac Dis. 2023 May 30;15(5):2836-2847. doi: 10.21037/jtd-22-779. Epub 2023 Apr 25.

    PubMed 37324083

  • Putz L, Mayne A, Dincq AS. Jet Ventilation during Rigid Bronchoscopy in Adults: A Focused Review. Biomed Res Int. 2016;2016:4234861. doi: 10.1155/2016/4234861. Epub 2016 Oct 26.

    PubMed 27847813

  • Poling HE, Wolfson B, Siker ES. A technique of ventilation during laryngoscopy and bronchoscopy. Br J Anaesth. 1975 Mar;47(3):382-4. doi: 10.1093/bja/47.3.382.

    PubMed 1138745

  • Klain M, Smith RB. High frequency percutaneous transtracheal jet ventilation. Crit Care Med. 1977 Nov-Dec;5(6):280-7. doi: 10.1097/00003246-197711000-00007. No abstract available.

    PubMed 338247

  • Hautmann H, Gamarra F, Henke M, Diehm S, Huber RM. High frequency jet ventilation in interventional fiberoptic bronchoscopy. Anesth Analg. 2000 Jun;90(6):1436-40. doi: 10.1097/00000539-200006000-00034.

    PubMed 10825336

  • Ost DE, Ernst A, Grosu HB, Lei X, Diaz-Mendoza J, Slade M, Gildea TR, Machuzak M, Jimenez CA, Toth J, Kovitz KL, Ray C, Greenhill S, Casal RF, Almeida FA, Wahidi M, Eapen GA, Yarmus LB, Morice RC, Benzaquen S, Tremblay A, Simoff M; AQuIRE Bronchoscopy Registry. Complications Following Therapeutic Bronchoscopy for Malignant Central Airway Obstruction: Results of the AQuIRE Registry. Chest. 2015 Aug;148(2):450-471. doi: 10.1378/chest.14-1530.

    PubMed 25741903

  • Goudra BG, Singh PM, Borle A, Farid N, Harris K. Anesthesia for Advanced Bronchoscopic Procedures: State-of-the-Art Review. Lung. 2015 Aug;193(4):453-65. doi: 10.1007/s00408-015-9733-7. Epub 2015 Apr 29.

    PubMed 25921014

  • Fernandez-Bustamante A, Ibanez V, Alfaro JJ, de Miguel E, German MJ, Mayo A, Jimeno A, Perez-Cerda F, Escribano PM. High-frequency jet ventilation in interventional bronchoscopy: factors with predictive value on high-frequency jet ventilation complications. J Clin Anesth. 2006 Aug;18(5):349-56. doi: 10.1016/j.jclinane.2005.12.011.

    PubMed 16905080

  • Maeyens C, Leduc D, Fils JF, Tuna T, Schmartz D. Complications during interventional rigid bronchoscopy with general anaesthesia and high-frequency jet ventilation: a 5-year retrospective pilot study. Eur J Anaesthesiol Intensive Care. 2026 Apr 1;5(3):e0105-18. doi: 10.1097/EA9.0000000000000105. eCollection 2026 Jun.

    PubMed 42244831

Questions about this trial

What is this clinical trial studying?

An observational study of High-Frequency Jet Ventilation and Bronchoscopy, run by Erasme University Hospital at 1 site in Belgium.

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 1 inclusion and 2 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 21 May 2025. 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 Belgium. 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?

Occurence of complications (time frame: 6 hours). 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 NCT06285994, which also lists 9 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 21 May 2025.

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