NCT06537388

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

August 1, 2024

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Hypoxia

    defined as an SpO2 \< 90% for more than 1 min

    24 hours

  • Severe hypoxia

    defined as an SpO2 (oxygen saturation by pulse oximetry) \< 85% for more than 1 min

    24 hours

  • Hemodynamic instability

    defined as a systolic arterial blood pressure \< 90/60 mm Hg

    24 hours

  • Cardiac arrythmia

    Any cardiac rhythm other than sinus rhythm

    24 hours

  • Laryngospasm

    Any occurence of laryngospasm

    24 hours

  • ICU admission

    Necessity for admission to the intensive care unit (ICU)

    24 hours

Study Arms (1)

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

Procedure: Ventilation type

Interventions

Type of ventilation used during the EBUS procedure, either HFJV or IPPV

EBUS_cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Incomplete medical chart
  • Patients who expressed an opposition to the use of their medical data
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Universitaire de Bruxelles - Hôpital erasme

Brussels, 1070, Belgium

Location

Related Publications (5)

  • 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.

    PMID: 27829719BACKGROUND
  • 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.

    PMID: 32453167BACKGROUND
  • 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.

    PMID: 1138745BACKGROUND
  • 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.

    PMID: 338247BACKGROUND
  • 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.

    PMID: 10825336BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 5, 2024

Study Start

August 15, 2024

Primary Completion

March 30, 2025

Study Completion

May 1, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations