- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06537388
High Frequency Jet Ventilation Versus Conventional Positive Pressure Ventilation for EBUS
May 20, 2025 updated by: Erasme University Hospital
Comparison of High Frequency Jet Ventilation and Conventional Positive Pressure Ventilation for Endobronchial Ultrasound Examinations
Endobronchial ultrasound (EBUS) is frequently used in pneumology for diagnostic procedures like mediastinal biopsies. This procedure is usually done under general anesthesia. Different methods of ventilation are used according to center and physician preferences. In this retrospective study, complications of 2 types of ventilation will be analyzed:
- High frequency jet ventilation (HFJV)
- Conventional intermittent positive pressure ventilation (IPPV) Descriptive statistics will be used to present the data. Both ventilation techniques will be compared after propensity score matching. For HFJV patients from 2019 will be analyzed and for IPPV patients from 2023, as the team changed its practice over time.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
428
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, 1070
- Hopital Universitaire de Bruxelles - Hopital Erasme
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients who underwent EBUS for any indication at Erasme University Hospital using either HFJV or IPPV between january 1st 2019 and december 31st 2019 or january 1st 2023 and december 31st 2023.
Description
Inclusion Criteria:
- All patients who underwent EBUS at Erasme University Hospital using either HFJV or IPPV between january 1st 2019 and december 31st 2019 or january 1st 2023 and december 31st 2023.
Exclusion Criteria:
- Incomplete medical chart
- Patients who expressed an opposition to the use of their medical data
- Age < 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
EBUS_cohort
All patients who underwent EBUS between January 1st 2019 and december 31st 2019 or January 1st 2023 and december 31st 2023 at Erasme University Hospital
|
Type of ventilation used during the EBUS procedure, either HFJV or IPPV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hypoxia
Time Frame: 24 hours
|
defined as an SpO2 < 90% for more than 1 min
|
24 hours
|
|
Severe hypoxia
Time Frame: 24 hours
|
defined as an SpO2 (oxygen saturation by pulse oximetry) < 85% for more than 1 min
|
24 hours
|
|
Hemodynamic instability
Time Frame: 24 hours
|
defined as a systolic arterial blood pressure < 90/60 mm Hg
|
24 hours
|
|
Cardiac arrythmia
Time Frame: 24 hours
|
Any cardiac rhythm other than sinus rhythm
|
24 hours
|
|
Laryngospasm
Time Frame: 24 hours
|
Any occurence of laryngospasm
|
24 hours
|
|
ICU admission
Time Frame: 24 hours
|
Necessity for admission to the intensive care unit (ICU)
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Prasad KT, Sehgal IS, Gupta N, Singh N, Agarwal R, Dhooria S. Endoscopic ultrasound (with an echobronchoscope)-guided fine-needle aspiration for diagnosis of a mediastinal lesion in a mechanically ventilated patient: A case report and systematic review of the literature. Indian J Crit Care Med. 2016 Oct;20(10):608-612. doi: 10.4103/0972-5229.192057.
- Anwar M, Fritze R, Base E, Wasserscheid T, Wolfram N, Koinig H, Hackner K, Lambers C, Schweiger T, Errhalt P, Hoda MA. Infraglottic versus supraglottic jet-ventilation for endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):999-1007. doi: 10.1097/EJA.0000000000001220.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2024
Primary Completion (Actual)
March 30, 2025
Study Completion (Actual)
May 1, 2025
Study Registration Dates
First Submitted
August 1, 2024
First Submitted That Met QC Criteria
August 1, 2024
First Posted (Actual)
August 5, 2024
Study Record Updates
Last Update Posted (Actual)
May 21, 2025
Last Update Submitted That Met QC Criteria
May 20, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- SRB2024173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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